Trial Outcomes & Findings for The Role of Partial Reinforcement in the Long Term Management of Insomnia (NCT NCT00662155)

Results Overview

The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

129 participants

Primary outcome timeframe

12-week average during Phase 3

Results posted on

2017-08-07

Participant Flow

129 individuals were eligible for Phase 1 (2-week assessment period) of the study. 12 participants were withdrawn for non-compliance, 14 dropped out, 28 did not experience a treatment response during Phase 2, and 1 discontinued due to a minor adverse event. In total, 74 participants advanced to phase 3 of the study.

Participant milestones

Participant milestones
Measure	QHS-10 nightly dosing with 10 mg zolpidem	IDS-10 intermittent dosing (3-5 days per week) with 10mg zolpidem	PRS-10 nightly "pill use" (50% 10mg zolpidem and 50% placebos)	QHS-5 nightly dosing with 5mg zolpidem
Overall Study STARTED	16	20	20	18
Overall Study COMPLETED	13	15	13	14
Overall Study NOT COMPLETED	3	5	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Partial Reinforcement in the Long Term Management of Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QHS-10 n=13 Participants nightly dosing with 10 mg zolpidem	IDS-10 n=15 Participants intermittent dosing (3-5 days per week) with 10mg zolpidem	PRS-10 n=13 Participants nightly "pill use" (50% 10mg zolpidem and 50% placebos)	QHS-5 n=14 Participants nightly dosing with 5mg zolpidem	Total n=55 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 2.8 • n=93 Participants	34.0 years STANDARD_DEVIATION 2.6 • n=4 Participants	39.2 years STANDARD_DEVIATION 2.8 • n=27 Participants	34.5 years STANDARD_DEVIATION 2.7 • n=483 Participants	37 years STANDARD_DEVIATION 2.8 • n=36 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	11 Participants n=4 Participants	11 Participants n=27 Participants	11 Participants n=483 Participants	43 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	12 Participants n=36 Participants
Region of Enrollment United States	13 participants n=93 Participants	15 participants n=4 Participants	13 participants n=27 Participants	14 participants n=483 Participants	55 participants n=36 Participants

PRIMARY outcome

Timeframe: 12-week average during Phase 3

Population: These were participants that meant compliance criteria and were included in all analyses.

The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.

Outcome measures

Outcome measures
Measure	QHS-10 n=13 Participants nightly dosing with 10 mg zolpidem	IDS-10 n=15 Participants intermittent dosing (3-5 days per week) with 10mg zolpidem	PRS-10 n=13 Participants nightly "pill use" (50% 10mg zolpidem and 50% placebos)	QHS-5 n=14 Participants nightly dosing with 5mg zolpidem
Overall Average Sleep Continuity Profile Sleep Latency	28.8 minutes Standard Error 3.4	33.8 minutes Standard Error 4.2	19.1 minutes Standard Error 3.8	20.7 minutes Standard Error 2.0
Overall Average Sleep Continuity Profile Wake After Sleep Onset	21.8 minutes Standard Error 2.6	28.4 minutes Standard Error 5.2	20.0 minutes Standard Error 4.3	11.3 minutes Standard Error 3.6
Overall Average Sleep Continuity Profile Total Sleep Time	465 minutes Standard Error 14.4	426.1 minutes Standard Error 9.4	463.6 minutes Standard Error 12.7	486.6 minutes Standard Error 11.1

PRIMARY outcome

Timeframe: 12-week average during Phase 3

Population: These were participants that meant compliance criteria and were included in all analyses.

The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep efficiency (total sleep time/time in bed x 100) as a function of treatment.

Outcome measures

Outcome measures
Measure	QHS-10 n=13 Participants nightly dosing with 10 mg zolpidem	IDS-10 n=15 Participants intermittent dosing (3-5 days per week) with 10mg zolpidem	PRS-10 n=13 Participants nightly "pill use" (50% 10mg zolpidem and 50% placebos)	QHS-5 n=14 Participants nightly dosing with 5mg zolpidem
Overall Average Sleep Efficiency (%)	90.1 percent sleep efficiency Standard Error 0.8	87.5 percent sleep efficiency Standard Error 1.6	92.0 percent sleep efficiency Standard Error 1.2	93.8 percent sleep efficiency Standard Error 0.9

Adverse Events

QHS-10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IDS-10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRS-10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

QHS-5

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

Michael Perlis

University of Pennsylvania

Phone: (215) 746-3577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place