CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Desipramine +1 moredrug
Likely dose
Desipramine 200 mg orally administered 2 hours before normal sleep timeAI-extracted
Key inclusion· 1
  • Diagnosed moderate-to-severe obstructive sleep apnea with apnea hypopnea index >15 events/hr
Key exclusion· 2
  • Cardiovascular disease other than well controlled hypertension
  • Depression

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

Search/NCT02436031
NCT02436031Phase 2Completed

The Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity During Sleep in Patients With Obstructive Sleep Apnea - Study B

Brigham and Women's Hospital·interventional·Posted May 6, 2015·Updated Mar 30, 2017

In Brief

A Phase 2 clinical trial evaluating Desipramine and Placebo for Sleep Apnea, Obstructive. Completed, enrolled 16 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 upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA patients.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 6, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 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