Trial Outcomes & Findings for Improving Sleep Quality in Heart Failure (NCT NCT03307005)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

1 week

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Zolpidem Tartrate Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights	Placebo Placebo oral capsule: Placebo capsule one per night taken for 7 nights
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo	Total n=5 Participants Total of all reporting groups
Age, Continuous	60.3 years n=3 Participants	67.5 years n=2 Participants	63.2 years n=5 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	2 Participants n=2 Participants	4 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Sleep Latency	-73.3 minutes Interval -143.0 to 0.2	21.9 minutes Interval -5.5 to 49.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Total Sleep Time	67.8 minutes Interval 36.5 to 125.3	-87.3 minutes Interval -184.5 to 10.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Sleep Efficiency	7.3 sleep efficiency percentage Interval 0.0 to 17.0	-5.5 sleep efficiency percentage Interval -33.0 to 22.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores \>=15 are signify the presence of insomnia

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Insomnia Severity Index Baseline ISI score	16.7 score on a scale Interval 11.0 to 24.0	14 score on a scale Interval 12.0 to 16.0
Insomnia Severity Index Final ISI score	11 score on a scale Interval 4.0 to 23.0	13.5 score on a scale Interval 11.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Kansas City Cardiomyopathy Questionnaire Baseline KCCQ-23 Score	91.7 score on a scale Interval 77.0 to 120.0	99 score on a scale Interval 85.0 to 113.0
Kansas City Cardiomyopathy Questionnaire Final KCCQ-23 Score	97.3 score on a scale Interval 80.0 to 117.0	100 score on a scale Interval 95.0 to 105.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Epworth Sleepiness Scale Baseline ESS score	10.3 score on a scale Interval 5.0 to 16.0	12.5 score on a scale Interval 8.0 to 17.0
Epworth Sleepiness Scale Final ESS score	7 score on a scale Interval 1.0 to 16.0	13 score on a scale Interval 7.0 to 19.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Participants received seven nights of zolpidem 5 mg	Control n=2 Participants Participants received seven nights of placebo
Pittsburgh Sleep Quality Index Baseline PSQI score	10.7 score on a scale Interval 8.0 to 14.0	12 score on a scale Interval 10.0 to 14.0
Pittsburgh Sleep Quality Index Final PSQI score	11.3 score on a scale Interval 9.0 to 15.0	11 score on a scale Interval 10.0 to 12.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rashmi Nisha Aurora, MD, MHS

Johns Hopkins University

Phone: 443-513-6535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place