Trial Outcomes & Findings for Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea (NCT NCT02387710)

Results Overview

Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

1 night

Results posted on

2017-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tiagabine First, Placebo Second Tiagabine 12 mg administered at normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching tiagabine administered at normal sleep time on second study night.	Placebo First, Tiagabine Second Placebo-matching tiagabine administered at normal sleep timeon first study night, then a 1-week non-treatment, then tiagabine 12 mg administered at normal sleep time on second study night
First Study Night STARTED	9	9
First Study Night COMPLETED	9	9
First Study Night NOT COMPLETED	0	0
Second Study Night STARTED	9	7
Second Study Night COMPLETED	9	7
Second Study Night NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Analyzed Participants n=14 Participants All patients who were randomized, completed both study nights and were included in the analysis
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.

Outcome measures

Outcome measures
Measure	Tiagabine n=14 Participants Tiagabine 12 mg administered at sleep time on the first or second study night	Placebo n=14 Participants Placebo administered at sleep time on the first or second study night
Apnea Hypopnea Index (AHI)	39.1 events/hour Interval 32.1 to 48.7	40.8 events/hour Interval 31.4 to 51.7

SECONDARY outcome

Timeframe: 1 night

Fraction of sleep spent in stage N3

Outcome measures

Outcome measures
Measure	Tiagabine n=14 Participants Tiagabine 12 mg administered at sleep time on the first or second study night	Placebo n=14 Participants Placebo administered at sleep time on the first or second study night
Slow Wave Sleep (% Total Sleep Time)	8.3 % total sleep time Interval 4.52 to 20.6	8.8 % total sleep time Interval 5.2 to 15.7

SECONDARY outcome

Timeframe: 1 night

The arousal threshold was quantified as the mean of all the nadir negative esophageal pressure swings immediately preceding an arousal at the end of an obstructive apnea or hypopnea during both placebo and tiagabine nights.

Outcome measures

Outcome measures
Measure	Tiagabine n=14 Participants Tiagabine 12 mg administered at sleep time on the first or second study night	Placebo n=14 Participants Placebo administered at sleep time on the first or second study night
Arousal Threshold (Esophageal Pressure Swing)	-27.6 cmH2O Interval -28.6 to -23.6	-26.5 cmH2O Interval -27.9 to -23.0

Adverse Events

Tiagabine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Andrew Wellman, MD, PhD

Brigham and women's Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place