CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Desipramine +1 moredrug
Likely dose
Desipramine 200 mgfrom 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/NCT02428478
NCT02428478Phase 2Completed

The Effect of Desipramine on Genioglossus Muscle Activity During Sleep in Healthy Control Subjects

Brigham and Women's Hospital·interventional·Posted Apr 28, 2015·Updated Mar 30, 2017

In Brief

A Phase 2 clinical trial evaluating Desipramine and Placebo for Sleep Apnea, Obstructive. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 28, 2015
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.2 years ago

Interventions

Desipraminedrug

200 mg administered 2 hours before normal sleep time

Placebodrug

Placebo-matching desipramine administered 2 hours before normal sleep time