Heart Failure, Sleep Disturbance
Conditions
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.
Interventions
Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
DRUGPlacebo oral capsule
Placebo capsule one per night taken for 7 nights
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Single-site, randomized, parallel, placebo controlled, double blind study
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants received seven nights of zolpidem 5 mg | 3 |
| Control Participants received seven nights of placebo | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 67.5 years | 63.2 years | 60.3 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Sleep Efficiency | 7.3 sleep efficiency percentage |
| Control | Sleep Efficiency | -5.5 sleep efficiency percentage |
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Sleep Latency | -73.3 minutes |
| Control | Sleep Latency | 21.9 minutes |
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Total Sleep Time | 67.8 minutes |
| Control | Total Sleep Time | -87.3 minutes |
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.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Epworth Sleepiness Scale | Baseline ESS score | 10.3 score on a scale |
| Intervention | Epworth Sleepiness Scale | Final ESS score | 7 score on a scale |
| Control | Epworth Sleepiness Scale | Baseline ESS score | 12.5 score on a scale |
| Control | Epworth Sleepiness Scale | Final ESS score | 13 score on a scale |
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
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Insomnia Severity Index | Final ISI score | 11 score on a scale |
| Intervention | Insomnia Severity Index | Baseline ISI score | 16.7 score on a scale |
| Control | Insomnia Severity Index | Final ISI score | 13.5 score on a scale |
| Control | Insomnia Severity Index | Baseline ISI score | 14 score on a scale |
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.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Kansas City Cardiomyopathy Questionnaire | Baseline KCCQ-23 Score | 91.7 score on a scale |
| Intervention | Kansas City Cardiomyopathy Questionnaire | Final KCCQ-23 Score | 97.3 score on a scale |
| Control | Kansas City Cardiomyopathy Questionnaire | Baseline KCCQ-23 Score | 99 score on a scale |
| Control | Kansas City Cardiomyopathy Questionnaire | Final KCCQ-23 Score | 100 score on a scale |
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
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Pittsburgh Sleep Quality Index | Baseline PSQI score | 10.7 score on a scale |
| Intervention | Pittsburgh Sleep Quality Index | Final PSQI score | 11.3 score on a scale |
| Control | Pittsburgh Sleep Quality Index | Baseline PSQI score | 12 score on a scale |
| Control | Pittsburgh Sleep Quality Index | Final PSQI score | 11 score on a scale |