CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Placebo pill +3 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/NCT01633827
NCT01633827N/ACompleted

Combination Therapy for the Treatment of Obstructive Sleep Apnea

Brigham and Women's Hospital·interventional·Posted Jul 4, 2012·Updated Mar 3, 2017

In Brief

A clinical study evaluating Placebo pill, Sedative, and 2 other interventions for Sleep Apnea, Obstructive. Completed, enrolled 22 participants across 1 site.

Detailed Summary

In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure \[CPAP\] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will improve OSA severity by altering some of the traits that are responsible for the disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 4, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.0 years ago

Interventions

Placebo pilldrug

Subjects will receive a sugar pill (in combination with room air) during their placebo arm studies

Sedativedrug

Subjects will receive eszopiclone (in combination with medical oxygen) during their treatment arm studies

Room airother

Subjects will receive room air (in combination with a sugar pill) during their placebo arm studies

Oxygenother

Subjects will receive medical grade oxygen (in combination with eszopiclone) during their treatment arm studies