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Improving Sleep Quality in Heart Failure

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ClinicalTrials.gov Identifier: NCT03307005
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Heart Failure Drug: Zolpidem Tartrate Drug: Placebo oral capsule Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-site, randomized, parallel, placebo controlled, double blind study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Improving Sleep Quality in Heart Failure
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Sleep architecture [ Time Frame: 1 week ]
    change in sleep latency as measured on a home sleep study measured in minutes

  2. Sleep architecture [ Time Frame: 1 week ]
    change in total sleep time as measured on a home sleep study measured in minutes

  3. Sleep architecture [ Time Frame: 1 week ]
    change in sleep efficiency as measured on a home sleep study measured as a percentage


Other Outcome Measures:
  1. Insomnia Severity Index [ Time Frame: 1 week ]
    a questionnaire that assesses insomnia severity

  2. Kansas City Cardiomyopathy Questionnaire [ Time Frame: 1 week ]
    a validated, disease specific, health status measure for patients with heart failure

  3. Epworth Sleepiness Scale [ Time Frame: 1 week ]
    a validated questionnaire that assesses chronic subjective sleepiness

  4. Pittsburgh Sleep Quality Index [ Time Frame: 1 week ]
    a self report questionnaire that assess sleep quality



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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307005


Contacts
Contact: Rashmi Aurora, MD 410-550-4891 rnaurora@jhmi.edu
Contact: Jasmine Jaber, BA 410-550-4891 jjaber1@jhu.edu

Locations
United States, Maryland
Johns Hopkins Bayview Campus, Asthma and Allergy Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Rashmi N Aurora, MD    410-550-4891    rnaurora@jhmi.edu   
Contact: Jasmine Jasber, BS    410-550-4891    jjaber1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Rashmi Aurora, MD Johns Hopkins University, School of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03307005     History of Changes
Other Study ID Numbers: IRB00142395
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Heart Failure
Dyssomnias
Sleep Wake Disorders
Parasomnias
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action