Trial · NCT02387710

Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea

NCT02387710, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2017-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea. Trials, record NCT02387710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02387710

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
NCT number: NCT02387710
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Sleep Apnea, Obstructive
Interventions: Tiagabine, Placebo
First posted: 2015-03-13
Last updated: 2017-08-15
Results first posted: 2017-06-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apnea Hypopnea Index (AHI)	1 night	Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.
Secondary	Slow Wave Sleep (% Total Sleep Time)	1 night	Fraction of sleep spent in stage N3
Secondary	Arousal Threshold (Esophageal Pressure Swing)	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Apnea Hypopnea Index (AHI)	1 night	events/hour	MEDIAN
SECONDARY	Slow Wave Sleep (% Total Sleep Time)	1 night	% total sleep time	MEDIAN
SECONDARY	Arousal Threshold (Esophageal Pressure Swing)	1 night	cmH2O	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Apnea Hypopnea Index (AHI)	Tiagabine	39.1	Inter-Quartile Range 32.1 to 48.7	events/hour
Apnea Hypopnea Index (AHI)	Placebo	40.8	Inter-Quartile Range 31.4 to 51.7	events/hour
Slow Wave Sleep (% Total Sleep Time)	Tiagabine	8.3	Inter-Quartile Range 4.52 to 20.6	% total sleep time
Slow Wave Sleep (% Total Sleep Time)	Placebo	8.8	Inter-Quartile Range 5.2 to 15.7	% total sleep time
Arousal Threshold (Esophageal Pressure Swing)	Tiagabine	-27.6	Inter-Quartile Range -28.6 to -23.6	cmH2O
Arousal Threshold (Esophageal Pressure Swing)	Placebo	-26.5	Inter-Quartile Range -27.9 to -23	cmH2O

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Study Night	STARTED	Tiagabine First, Placebo Second	9
First Study Night	STARTED	Placebo First, Tiagabine Second	9
First Study Night	COMPLETED	Tiagabine First, Placebo Second	9
First Study Night	COMPLETED	Placebo First, Tiagabine Second	9
First Study Night	NOT COMPLETED	Tiagabine First, Placebo Second	0
First Study Night	NOT COMPLETED	Placebo First, Tiagabine Second	0
Second Study Night	STARTED	Tiagabine First, Placebo Second	9
Second Study Night	STARTED	Placebo First, Tiagabine Second	7
Second Study Night	COMPLETED	Tiagabine First, Placebo Second	9
Second Study Night	COMPLETED	Placebo First, Tiagabine Second	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Tiagabine	14
Total, all-cause mortality	Placebo	14
Total, other adverse events	Tiagabine	14
Total, other adverse events	Placebo	14
Total, serious adverse events	Tiagabine	14
Total, serious adverse events	Placebo	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28364504	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tiagabine vs Placebo: deaths from any cause	Trial comparisons
Tiagabine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02387710

GET https://conductscience.org/api/trials/v1/NCT02387710/registered

API reference For AI assistants