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Improving Sleep Quality in Heart Failure

Primary Purpose

Sleep Disturbance, Heart Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zolpidem Tartrate
Placebo oral capsule
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Campus, Asthma and Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2017
Last Updated
February 10, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03307005
Brief Title
Improving Sleep Quality in Heart Failure
Official Title
Improving Sleep Quality in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Single-site, randomized, parallel, placebo controlled, double blind study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zolpidem Tartrate
Intervention Description
Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo capsule one per night taken for 7 nights
Primary Outcome Measure Information:
Title
Sleep Latency
Description
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
Title
Total Sleep Time
Description
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
Title
Sleep Efficiency
Description
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
Other Pre-specified Outcome Measures:
Title
Insomnia Severity Index
Description
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
Title
Kansas City Cardiomyopathy Questionnaire
Description
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
Title
Epworth Sleepiness Scale
Description
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
Title
Pittsburgh Sleep Quality Index
Description
a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashmi Aurora, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Campus, Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improving Sleep Quality in Heart Failure

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