NCT06286189

Trazodone on OSA Endotypes

Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Placebo oral tablet	Placebo capsule taken 30 min before sleep
DRUG	Trazodone Hydrochloride	Trazodone 100 mg 30 min before sleep

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-02-29
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study