Trazodone on OSA Endotypes

Status Recruiting

Clinical Trial Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.

Clinical Trial Description

Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06286189
Study type	Interventional
Source	Brigham and Women's Hospital
Contact	Ludovico Messineo
Phone	(617) 732-4013
Email	lmessineo@bwh.harvard.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 1, 2024
Completion date	June 1, 2025

View Details

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