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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem Tartrate | Drug | Zolpidem tartrate 5 mg capsule one per night taken for 7 nights |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency | 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. | 1 week |
| Total Sleep Time | 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. | 1 week |
| Sleep Efficiency | 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. | 1 week |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia | 1 week |
| Kansas City Cardiomyopathy Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Aurora, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Campus, Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zolpidem Tartrate | Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights |
| FG001 | Placebo | Placebo oral capsule: Placebo capsule one per night taken for 7 nights |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Persons with heart failure and insomnia
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants received seven nights of zolpidem 5 mg |
| BG001 | Control | Participants received seven nights of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Latency | 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. | Posted | Mean | Full Range | minutes | 1 week |
|
|
15 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rashmi Nisha Aurora, MD, MHS | Johns Hopkins University | 443-513-6535 | rnaurora@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2018 | Feb 10, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single-site, randomized, parallel, placebo controlled, double blind study
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| Placebo oral capsule |
| Drug |
Placebo capsule one per night taken for 7 nights |
|
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.
| 1 week |
| Epworth Sleepiness Scale | 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. | 1 week |
| Pittsburgh Sleep Quality Index | a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality | 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Total Sleep Time | 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. | Posted | Mean | Full Range | minutes | 1 week |
|
|
|
| Primary | Sleep Efficiency | 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. | Posted | Mean | Full Range | sleep efficiency percentage | 1 week |
|
|
|
| Other Pre-specified | Insomnia Severity Index | a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia | Posted | Mean | Full Range | score on a scale | 1 week |
|
|
|
| Other Pre-specified | Kansas City Cardiomyopathy Questionnaire | 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. | Posted | Mean | Full Range | score on a scale | 1 week |
|
|
|
| Other Pre-specified | Epworth Sleepiness Scale | 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. | Posted | Mean | Full Range | score on a scale | 1 week |
|
|
|
| Other Pre-specified | Pittsburgh Sleep Quality Index | a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality | Posted | Mean | Full Range | score on a scale | 1 week |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Control | Placebo oral capsule: Placebo capsule one per night taken for 7 nights | 0 | 2 | 0 | 2 | 0 | 2 |
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| D002318 |
| Cardiovascular Diseases |