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OpenTrials
Completed

NCT Number: NCT03307005

Improving Sleep Quality in Heart Failure

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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Key information

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Bayview Campus, Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolpidem Tartrate

Drug

Zolpidem tartrate 5 mg capsule one per night taken for 7 nights

Placebo oral capsule

Drug

Placebo capsule one per night taken for 7 nights

Primary outcomes

  1. Sleep Latency

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Insomnia Severity Index

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2017
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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