Improving Sleep Quality in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Improving Sleep Quality in Heart Failure

Conditions
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Sleep Disturbance, Heart Failure

Intervention / Treatment
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* Drug: Zolpidem Tartrate
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-site, randomized, parallel, placebo controlled, double blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Drug: Zolpidem Tartrate<br>* Zolpidem tartrate 5 mg capsule one per night taken for 7 nights<br>|
| Placebo Comparator: Control<br> | Drug: Placebo oral capsule<br>* Placebo capsule one per night taken for 7 nights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |