Johns Hopkins Bayview Campus, Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT03307005
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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Notify Me21 year–79 year
All sexes
Interventional
Phase 4
Baltimore, Maryland, 21224, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
Placebo capsule one per night taken for 7 nights
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.
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.
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.
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
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.
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.
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
Johns Hopkins University
Other
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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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