CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 17 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Eszopiclone 3mgfrom 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/NCT01102270
NCT01102270Early Ph 1Completed
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A Double-Blind Randomized Physiological Study Examining the Effects of Eszopiclone on the Arousal Threshold and Obstructive Sleep Apnea Severity

Brigham and Women's Hospital·interventional·Posted Apr 13, 2010·Updated Apr 18, 2017

In Brief

A Early Phase 1 clinical trial evaluating Eszopiclone and Placebo for Obstructive Sleep Apnea. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc., National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Early Ph 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2010
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.2 years ago

Interventions

Eszopiclonedrug

3mg tablet once prior to sleep

Placebodrug

1 placebo capsule prior to sleep