CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Tiagabine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02387710
NCT02387710Phase 2Completed
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Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea

Brigham and Women's Hospital·interventional·Posted Mar 13, 2015·Updated Aug 15, 2017

In Brief

A Phase 2 clinical trial evaluating Tiagabine and Placebo for Sleep Apnea, Obstructive. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with this intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obstructive
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 13, 2015
Enrollment StartMar 1, 2015
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.3 years ago

Interventions

Tiagabinedrug

GABA reuptake inhibitor

Placebodrug

Placebo comparator