Improving Sleep Quality in Heart Failure

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03307005
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance; Heart Failure	Drug: Zolpidem Tartrate; Drug: Placebo oral capsule	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-site, randomized, parallel, placebo controlled, double blind studySingle-site, randomized, parallel, placebo controlled, double blind study
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Improving Sleep Quality in Heart Failure
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Jan 25, 2019
• Actual Study Completion Date: Jan 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Drug: Zolpidem Tartrate; Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
Placebo Comparator: Control	Drug: Placebo oral capsule; Placebo capsule one per night taken for 7 nights

Outcome Measures

Primary Outcome Measures

1. Sleep Latency [1 week]

   Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.

2. Total Sleep Time [1 week]

   Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.

3. Sleep Efficiency [1 week]

   Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.

Other Outcome Measures

1. Insomnia Severity Index [1 week]

   a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia

2. Kansas City Cardiomyopathy Questionnaire [1 week]

   a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.

3. Epworth Sleepiness Scale [1 week]

   a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.

4. Pittsburgh Sleep Quality Index [1 week]

   a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 21-79 years old

• HFrEF, EF ≤ 45% (by echocardiography)

• NYHA functional class I to III

• Able to give written consent

• On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment

• No hospitalizations for HF within the past month

• Positive response to experiencing any of the following sleep-related symptoms at least once a week:

• Difficulty falling asleep

• Waking up during the night and having difficulty getting back to sleep

• Waking up too early in the morning and being unable to get back to sleep.

Exclusion Criteria:

• Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks

• Current treatment with other sedating medications such as opioids

• On therapy for pharmacological therapy for depression

• History of alcohol/drug dependence

• History of liver disease, HIV, or severe COPD

• On Thorazine

• Current use of ketoconazole

• Current use of tricyclic antidepressants

• Current use of macrolide antibiotics

• Current use of anticonvulsant medications

• Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Campus, Asthma and Allergy Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Rashmi Aurora, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 27, 2018

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03307005
• Other Study ID Numbers: IRB00142395
• First Posted: Oct 11, 2017
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Heart Failure; Zolpidem

Study Results

Participant Flow

Arm/Group Title	Zolpidem Tartrate	Placebo
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Period Title: Overall Study
STARTED	3	2
COMPLETED	3	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	Participants received seven nights of zolpidem 5 mg	Participants received seven nights of placebo	Total of all reporting groups
Overall Participants	3	2	5
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60.3	67.5	63.2
Sex: Female, Male (Count of Participants)
Female	1 33.3%	0 0%	1 20%
Male	2 66.7%	2 100%	4 80%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%	2 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Sleep Latency
Description	Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Participants received seven nights of zolpidem 5 mg	Participants received seven nights of placebo
Measure Participants	3	2
Mean (Full Range) [minutes]	-73.3	21.9

2. Primary Outcome

Title	Total Sleep Time
Description	Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Mean (Full Range) [minutes]	67.8	-87.3

3. Primary Outcome

Title	Sleep Efficiency
Description	Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Mean (Full Range) [sleep efficiency percentage]	7.3	-5.5

4. Other Pre-specified Outcome

Title	Insomnia Severity Index
Description	a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Baseline ISI score	16.7	14
Final ISI score	11	13.5

5. Other Pre-specified Outcome

Title	Kansas City Cardiomyopathy Questionnaire
Description	a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Baseline KCCQ-23 Score	91.7	99
Final KCCQ-23 Score	97.3	100

6. Other Pre-specified Outcome

Title	Epworth Sleepiness Scale
Description	a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Baseline ESS score	10.3	12.5
Final ESS score	7	13

7. Other Pre-specified Outcome

Title	Pittsburgh Sleep Quality Index
Description	a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Measure Participants	3	2
Baseline PSQI score	10.7	12
Final PSQI score	11.3	11

Adverse Events

Time Frame	15 months.
Arm/Group Title	Intervention		Control
Arm/Group Description	Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights		Placebo oral capsule: Placebo capsule one per night taken for 7 nights
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)

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.