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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sleep Disturbance
• Intervention / Treatment: Drug: Zolpidem Tartrate; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Campus, Asthma and Allergy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Drug: Zolpidem Tartrate; Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
Placebo Comparator: Control	Drug: Placebo oral capsule; Placebo capsule one per night taken for 7 nights

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week
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.	1 week
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.	1 week
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	1 week

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Rashmi Aurora, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Sleep Wake Disorders; Heart Failure; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: IRB00142395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No