Improving Sleep Quality in Heart Failure
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|ClinicalTrials.gov Identifier: NCT03307005|
Recruitment Status : Completed
First Posted : October 11, 2017
Results First Posted : February 10, 2020
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disturbance Heart Failure||Drug: Zolpidem Tartrate Drug: Placebo oral capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-site, randomized, parallel, placebo controlled, double blind study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Improving Sleep Quality in Heart Failure|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||January 25, 2019|
|Actual Study Completion Date :||January 25, 2019|
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
- Sleep Latency [ Time Frame: 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.
- Total Sleep Time [ Time Frame: 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.
- Sleep Efficiency [ Time Frame: 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.
- Insomnia Severity Index [ Time Frame: 1 week ]a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia
- Kansas City Cardiomyopathy Questionnaire [ Time Frame: 1 week ]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.
- Epworth Sleepiness Scale [ Time Frame: 1 week ]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.
- Pittsburgh Sleep Quality Index [ Time Frame: 1 week ]a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality
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
|United States, Maryland|
|Johns Hopkins Bayview Campus, Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Rashmi Aurora, MD||Johns Hopkins University|