Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A — DESOSA  

Sleep Apnea, Obstructive Clinical Trial

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

Status Completed

Clinical Trial 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 subjects. 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 subjects.

Clinical Trial Description

Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 2 hours before lights out. At least 15 minutes of quiet wakefulness will be recorded to quantify the subject's awake EMG GG activity. Subjects will then sleep in the lateral position to minimize pharyngeal resistance similar to previous studies of this kind.

The same will be done for stable NREM and REM sleep (free of arousals and other artifacts). Both NREM and REM sleep will be analyzed, recognizing that REM is less frequent on these drugs.

During the second part of the night, the subjects will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

• NCT number: NCT02428478
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Completion date: March 2016