Improving Sleep Quality in Heart Failure

Phase 4

Completed

• Conditions: Heart Failure; Sleep Disturbance
• Interventions: Drug: Zolpidem Tartrate; Drug: Placebo oral capsule

• Registration Number: NCT03307005
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Study Start: 2017-11-01
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Results First Submitted: 2020-01-23
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Results First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Zolpidem Tartrate	-
Control	Placebo oral capsule	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Johns Hopkins Bayview Campus, Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States