Improving Sleep Quality in Heart Failure

Heart Failure Clinical Trial

Official title:

Improving Sleep Quality in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307005
• Other study ID #: IRB00142395
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: January 25, 2019

Study information

• Verified date: February 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Heart Failure
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Drug:
• Zolpidem Tartrate
Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
• Placebo oral capsule
Placebo capsule one per night taken for 7 nights

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Campus, Asthma and Allergy Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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