CURE: Controlling Urgency Through Relaxation Exercises

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02202031
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 161
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:

1. practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urgency Urinary Symptoms; Urgency Incontinence	Behavioral: Paced Respiration; Behavioral: Music Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Therapy Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.	Behavioral: Music Therapy; Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
Experimental: Paced Respiration Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.	Behavioral: Paced Respiration; Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks. [Baseline to 12 weeks]

   Self-reported on voiding diary.

Secondary Outcome Measures

1. Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks. [Baseline to 12 weeks]

   Self-reported on voiding diary

2. Change From Baseline in Urgency Incontinence Episodes at 12 Weeks. [Baseline to 12 weeks.]

   Self-reported on voiding diary

3. Change From Baseline in Total Voiding Episodes at 12 Weeks. [Baseline to 12 weeks]

   Self-reported on voiding diary.

4. Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks [Baseline to 12 weeks.]

   A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.

5. Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks. [Baseline to 12 weeks.]

   A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.

6. Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks. [Baseline to 12 weeks]

   A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.

7. Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks. [Baseline to 12 weeks]

   A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.

8. Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks. [Baseline to 12 weeks]

   A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.

9. Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks. [Baseline to 12 Weeks]

   A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.

10. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks. [Baseline to 12 Weeks]

    A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.

11. Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks. [Baseline to 12 weeks]

    A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.

12. Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks. [Baseline to 12 weeks]

    A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.

13. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks. [Baseline to 12 weeks]

    An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.

14. Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks. [Baseline to 12 weeks]

    Resting (neutral) state

15. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks. [Baseline to 12 weeks]

    Change in autonomic control as assessed by high frequency heart rate variability (RSA)

16. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks. [Baseline to 12 weeks]

    High frequency heart rate variability

17. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks [Baseline to 12 weeks]

    high frequency heart rate variability

18. Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks. [Baseline to 12 weeks]

    PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .

19. Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks. [Baseline to 12 weeks]

    The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

20. Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks [Baseline to 12 weeks]

    The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Women aged 21 years or older who are able to walk to the bathroom without assistance

2. Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at least 3 months prior to screening

3. Able to record all voiding and incontinence episodes on a screening 3-day voiding diary29,30 and rate the severity of urgency associated with each episode using a validated urgency severity scale31

4. Document at least 9 voiding or incontinence episodes on the above 3-day voiding diary that are associated with at least moderate sensation of urgency (using the above validated urgency severity scale) 31

5. Willing to refrain from initiating other treatments that may affect voiding pattern during the trial period

Exclusion Criteria:

1. Use of anticholinergic OAB medications or other medications known to affect urinary function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening

2. Current urinary tract infection (detected via screening dipstick urinalysis or urine culture) or a history more than 3 urinary tract infections in the preceding 1 year

3. Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or other pelvic or abdominal surgery within 6 months of screening

4. History of interstitial cystitis, fistula in the bladder or rectum, or congenital or childhood defect leading to chronic urinary incontinence, retention, or other chronic urinary symptoms

5. Known history of major neurologic conditions likely to have major or permanent effects on bladder function such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease

6. Use of bladder botulinum injections, electrostimulation, or other invasive therapies for OAB or incontinence within 3 months of screening

7. Formal pelvic floor rehabilitation or other formal behavioral therapy for bladder symptoms involving a physical therapist or other certified practitioner within 3 months of screening

8. Started, stopped, or changed dosage of a psychoactive medication likely to affect anxiety (SSRIs/SNRIs, tricyclics) within 3 months of screening, or plans to start, stop, or change dosage during the trial

9. Resting blood pressure (average of 2 measures) less than 100/60 at screening (women with baseline low blood pressure may theoretically be at increased risk of hypotension with use of RESPeRATE)

10. Resting breathing rate already below 10 breaths/minute before treatment (as measured during run-in)

11. History of chronic pulmonary disease likely to interfere with breathing exercises (e.g., emphysema)

12. Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period

13. Unable or willing to sign an informed consent, fill out questionnaires, or undergo study procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115

Sponsors and Collaborators

• University of California, San Francisco
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Alison Huang, MD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2016

More Information

Publications

None provided.

• Responsible Party: Alison Huang, MD, Assistant Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02202031
• Other Study ID Numbers: 14-13319; 1R01AG047894
• First Posted: Jul 28, 2014
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Urinary Bladder, Overactive

Study Results

Participant Flow

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Period Title: Overall Study
STARTED	82	79
COMPLETED	77	74
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Music Therapy	Paced Respiration	Total
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration	Total of all reporting groups
Overall Participants	82	79	161
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.67 (10.9)	60.35 (11.4)	61.02 (11.1)
Sex: Female, Male (Count of Participants)
Female	82 100%	79 100%	161 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian/Asian-American	6 7.3%	7 8.9%	13 8.1%
Latina	6 7.3%	12 15.2%	18 11.2%
Mixed	7 8.5%	3 3.8%	10 6.2%
Non-Latina African-American	12 14.6%	12 15.2%	24 14.9%
Non-Latina White	49 59.8%	40 50.6%	89 55.3%
Unknown	2 2.4%	5 6.3%	7 4.3%
Region of Enrollment (participants) [Number]
United States	82 100%	79 100%	161 100%
Incontinence Frequency (Episodes per day) [Mean (Standard Deviation) ]
Urgency Incontinence	1.19 (1.6)	1.37 (2.0)	1.28 (1.8)
Moderate Sensation of Urgency Incontinence or Void	6.77 (3.8)	7.10 (2.9)	6.93 (3.4)
Severe Sensation of Urgency Incontinence or Void	2.42 (2.3)	3.01 (2.6)	2.71 (2.4)
Daytime voiding	9.70 (3.8)	9.81 (2.8)	9.76 (3.3)
Nighttime voiding	1.42 (1.0)	1.25 (1.0)	1.34 (1.0)
Total voiding	11.12 (3.9)	11.06 (2.9)	11.09 (3.4)
Overactive Bladder Questionnaire (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	27.59 (11.4)	29.12 (9.9)	28.35 (10.7)
Urgency Severity and Impact Questionnaire (score on scale) [Mean (Standard Deviation) ]
Severity Subscale	58.51 (11.7)	58.45 (14.5)	58.48 (13.1)
Health-Related Quality of Life Subscale	21.94 (15.4)	24.57 (19.4)	23.23 (17.5)
Urogenital Distress Inventory Short Form (UDI-6) (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	45.19 (17.3)	45.57 (19.6)	45.38 (18.4)
Patient Perception of Bladder Condition (PPBC) (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	2.65 (1.0)	2.61 (1.1)	2.63 (1.0)
Spielberger State Trait Anxiety Inventory (STAI), Trait Component (Score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on scale]	36.82 (10.2)	38.49 (10.5)	37.64 (10.3)
Hospital Anxiety and Depression Scale (HADS), Anxiety Subscale (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	6.22 (3.8)	6.72 (4.0)	6.47 (3.9)
Center for Epidemiologic Studies Depression Scale (CES-D) (Score on Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on Scale]	10.17 (8.5)	11.87 (10.1)	11.01 (9.3)
Perceived Stress Scale (PSS) (Score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on scale]	13.40 (6.6)	14.41 (7.0)	13.89 (6.8)
Pittsburgh Sleep Quality Index (PSQI) (Score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on scale]	7.11 (3.2)	7.42 (3.8)	7.26 (3.5)
Respiratory Sinus Arrhythmia (RSA) (msec^2) [Mean (Standard Deviation) ]
Change from rest to dot task	0.35 (0.6)	-0.11 (0.6)	0.08 (0.6)
Change from rest to maze task	-0.10 (0.6)	-0.56 (1.0)	-0.37 (0.9)
Resting (neutral) state	4.75 (1.2)	5.69 (1.6)	5.29 (1.5)
Pre-ejection Period (PEP) (msec) [Mean (Standard Deviation) ]
Change from rest to dot task	-3.84 (9.7)	-0.02 (6.1)	-1.67 (8.0)
Change from rest to maze task	-4.21 (11.6)	-0.81 (8.7)	-2.27 (10.1)
Resting (neutral) state	123.07 (11.5)	117.11 (14.8)	119.68 (13.7)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.
Description	Self-reported on voiding diary.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	73	74
Least Squares Mean (95% Confidence Interval) [episodes]	-1.06	-0.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6222
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95%; -0.73 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.
Description	Self-reported on voiding diary
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	73	74
Least Squares Mean (95% Confidence Interval) [episodes]	-0.85	-0.94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7695
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.
Description	Self-reported on voiding diary
Time Frame	Baseline to 12 weeks.

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	73	74
Least Squares Mean (95% Confidence Interval) [episodes]	-0.63	-0.55

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6456
	Comments
	Method	ANCOVA
	Comments	change from baseline value, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Total Voiding Episodes at 12 Weeks.
Description	Self-reported on voiding diary.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	73	74
Least Squares Mean (95% Confidence Interval) [episodes]	-1.04	-1.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9190
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks
Description	A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.
Time Frame	Baseline to 12 weeks.

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-15.45	-14.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5358
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; -2.51 to 4.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.
Description	A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.
Time Frame	Baseline to 12 weeks.

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-15.56	-13.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4663
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.72
	Confidence Interval	(2-Sided) 95%; -2.90 to 6.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.
Description	A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participants randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	73	71
Least Squares Mean (95% Confidence Interval) [score on a scale]	-12.35	-10.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3134
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.17
	Confidence Interval	(2-Sided) 95%; -2.05 to 6.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.
Description	A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-15.35	-17.11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5146
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.76
	Confidence Interval	(2-Sided) 95%; -7.05 to 3.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.
Description	A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-0.74	-0.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3611
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.44 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.
Description	A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-2.42	-2.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6722
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -2.43 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.
Description	A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-0.71	-1.38

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0786
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -1.4 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.
Description	A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-1.97	-3.01

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2284
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 95%; -2.87 to 0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.
Description	A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-1.12	-2.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0335
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.71
	Confidence Interval	(2-Sided) 95%; -3.28 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.
Description	An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	76	74
Least Squares Mean (95% Confidence Interval) [score on a scale]	-1.22	-1.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8408
	Comments
	Method	ANCOVA
	Comments	change from baseline, adjusted for baseline value
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.
Description	Resting (neutral) state
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	19	25
Least Squares Mean (95% Confidence Interval) [msec^2]	-0.40	-0.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments	adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic
Statistical Test of Hypothesis	p-Value	0.5578
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.
Description	Change in autonomic control as assessed by high frequency heart rate variability (RSA)
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	19	25
Least Squares Mean (95% Confidence Interval) [msec^2]	-0.40	-0.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5578
	Comments
	Method	ANCOVA
	Comments	Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.

17. Secondary Outcome

Title	Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.
Description	High frequency heart rate variability
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	19	25
Least Squares Mean (95% Confidence Interval) [msec2]	0.58	0.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7301
	Comments
	Method	ANCOVA
	Comments	adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks
Description	high frequency heart rate variability
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	19	25
Least Squares Mean (95% Confidence Interval) [msec^2]	0.69	0.26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6646
	Comments
	Method	ANCOVA
	Comments	adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.89 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.
Description	PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	18	24
Least Squares Mean (95% Confidence Interval) [msec]	-3.41	0.34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4993
	Comments
	Method	ANCOVA
	Comments	Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.

20. Secondary Outcome

Title	Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.
Description	The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	18	24
Least Squares Mean (95% Confidence Interval) [msec]	1.28	1.87

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7506
	Comments
	Method	ANCOVA
	Comments	adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; -3.05 to 4.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks
Description	The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.

Arm/Group Title	Music Therapy	Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy	Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
Measure Participants	18	24
Least Squares Mean (95% Confidence Interval) [msec]	-4.79	-6.35

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Music Therapy, Paced Respiration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6268
	Comments
	Method	ANCOVA
	Comments	adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.55
	Confidence Interval	(2-Sided) 95%; -6.98 to 3.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline to 12 weeks.
Adverse Event Reporting Description	At each phone and in-person contact, participants were asked about any negative changes in their health.
Arm/Group Title	Music Therapy		Paced Respiration
Arm/Group Description	Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy		Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration
All Cause Mortality
	Music Therapy		Paced Respiration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/79 (0%)
Serious Adverse Events
	Music Therapy		Paced Respiration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/79 (0%)
Other (Not Including Serious) Adverse Events
	Music Therapy		Paced Respiration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/82 (14.6%)		10/79 (12.7%)
Respiratory, thoracic and mediastinal disorders
Cold/Flu	12/82 (14.6%)	13	10/79 (12.7%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.