RecruitingPhase 1Phase 2NCT06286189

Trazodone on OSA Endotypes

Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity

Sponsor

Brigham and Women's Hospital

Enrollment

18 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Obstructive Sleep Apnea

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.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Inclusion Criteria1

Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Exclusion Criteria11

All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Use of SNRIs/SSRIs.
Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
Hypersensitivity to the study drug (angioedema or urticaria)
Contraindications to DAW2020
Use of medications that lengthen QTc interval
Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
Severe claustrophobia.