Understanding the Sleep Apnea/Insomnia Interaction

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01824472
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 45
• Location: 1
• Arms: 3
• Actual Duration (Months): 48
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders	Device: CPAP; Behavioral: CBT; Device: sham CPAP; Behavioral: CC	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CPAP+CC Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)	Device: CPAP; Treatment for sleep apnea; Other Names: Continuous positive airway pressure therapy ; Behavioral: CC; Placebo (sham) for insomnia; Other Names: Contact control
Sham Comparator: sham CPAP+CC sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)	Device: sham CPAP; Placebo for sleep apnea; Other Names: Sham (placebo) continuous positive airway pressure ; Behavioral: CC; Placebo (sham) for insomnia; Other Names: Contact control
Active Comparator: CPAP+CBT CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia	Device: CPAP; Treatment for sleep apnea; Other Names: Continuous positive airway pressure therapy ; Behavioral: CBT; Treatment for insomnia; Other Names: Cognitive-Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index Score [Between Baseline and Day 42.]

   Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Sleep Apnea

2. Insomnia

3. Age >18

Exclusion Criteria:

1. Sedative/psychoactive drug use recently

2. Other clinically significant sleep disorders

3. Previous treatment for obstructive sleep apnea (OSA)

4. Requires oxygen or bilevel PAP therapy

5. Clinically unstable medical condition

6. Recent shift work

7. Significant alcohol use

8. Other clinically significant causes of insomnia

9. Illicit drug use

10. Prescription stimulants

11. Safety restrictions

12. Unable to treat sleep apnea with positive airway pressure therapy

13. Communication barriers

14. Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 11, 2011

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01824472
• Other Study ID Numbers: 814153; R34HL109462
• First Posted: Apr 4, 2013
• Last Update Posted: Aug 5, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	CPAP+CC	Sham CPAP+CC	CPAP+CBT
Arm/Group Description	CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) CPAP: Treatment for sleep apnea CC: Placebo (sham) for insomnia	sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) sham CPAP: Placebo for sleep apnea CC: Placebo (sham) for insomnia	CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia
Period Title: Overall Study
STARTED	17	13	15
COMPLETED	16	6	11
NOT COMPLETED	1	7	4

Baseline Characteristics

Arm/Group Title	CPAP+CC	Sham CPAP+CC	CPAP+CBT	Total
Arm/Group Description	CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) CPAP: Treatment for sleep apnea CC: Placebo (sham) for insomnia	sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) sham CPAP: Placebo for sleep apnea CC: Placebo (sham) for insomnia	CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia	Total of all reporting groups
Overall Participants	17	13	15	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.9 (11.1)	49.4 (14.6)	48.5 (14.6)	48.2 (12.9)
Sex: Female, Male (Count of Participants)
Female	9 52.9%	5 38.5%	8 53.3%	22 48.9%
Male	8 47.1%	8 61.5%	7 46.7%	23 51.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 5.9%	0 0%	0 0%	1 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	9 52.9%	8 61.5%	5 33.3%	22 48.9%
White	5 29.4%	5 38.5%	8 53.3%	18 40%
More than one race	1 5.9%	0 0%	1 6.7%	2 4.4%
Unknown or Not Reported	1 5.9%	0 0%	1 6.7%	2 4.4%
Insomnia Severity Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	22.4 (3.5)	22.2 (3.1)	21.4 (3.0)	21.9 (3.2)

Outcome Measures

1. Primary Outcome

Title	Insomnia Severity Index Score
Description	Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Time Frame	Between Baseline and Day 42.

Outcome Measure Data

Analysis Population Description

Study participants who completed protocol

Arm/Group Title	CPAP+CC	Sham CPAP+CC	CPAP+CBT
Arm/Group Description	CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) CPAP: Treatment for sleep apnea CC: Placebo (sham) for insomnia	sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) sham CPAP: Placebo for sleep apnea CC: Placebo (sham) for insomnia	CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia
Measure Participants	16	6	11
Mean (Standard Deviation) [score on a scale]	-8.2 (6.49)	-7.33 (7.28)	-6.27 (5.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CPAP+CC, Sham CPAP+CC, CPAP+CBT
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	Kruskal-Wallis
	Comments
Method of Estimation	Estimation Parameter	Mean difference compared across 3 groups
	Estimated Value	0.43
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Kruskal-Wallis test implemented as "PROC NPAR1WAY" in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups.

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	We used the clinical trials website definitions
Arm/Group Title	CPAP+CC		Sham CPAP+CC		CPAP+CBT
Arm/Group Description	CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) CPAP: Treatment for sleep apnea CC: Placebo (sham) for insomnia		sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) sham CPAP: Placebo for sleep apnea CC: Placebo (sham) for insomnia		CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia
All Cause Mortality
	CPAP+CC		Sham CPAP+CC		CPAP+CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/13 (0%)		0/15 (0%)
Serious Adverse Events
	CPAP+CC		Sham CPAP+CC		CPAP+CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		2/13 (15.4%)		0/15 (0%)
Gastrointestinal disorders
Gastroenteritis	0/17 (0%)		1/13 (7.7%)	2	0/15 (0%)	2
Renal and urinary disorders
Kidney problems	0/17 (0%)		1/13 (7.7%)	1	0/15 (0%)	1
Other (Not Including Serious) Adverse Events
	CPAP+CC		Sham CPAP+CC		CPAP+CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/17 (23.5%)		1/13 (7.7%)		1/15 (6.7%)
Cardiac disorders
Atrial Fibrillation	0/17 (0%)		1/13 (7.7%)	1	0/15 (0%)	1
Ear and labyrinth disorders
Ear ache	1/17 (5.9%)	1	0/13 (0%)	1	0/15 (0%)	1
General disorders
Mouth pain	1/17 (5.9%)	1	0/13 (0%)	1	0/15 (0%)	1
Infections and infestations
Sinus infection	1/17 (5.9%)	1	0/13 (0%)	1	0/15 (0%)	1
Musculoskeletal and connective tissue disorders
Neck pain	1/17 (5.9%)	1	0/13 (0%)	1	0/15 (0%)	1
Nervous system disorders
Dizziness	0/17 (0%)		0/13 (0%)		1/15 (6.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.