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Recruiting Phase 1, Phase 2 NCT06286189

Trazodone on OSA Endotypes

Trial Parameters

Condition Obstructive Sleep Apnea
Sponsor Brigham and Women's Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 18
Sex ALL
Min Age 21 Years
Max Age 70 Years
Start Date 2024-01-01
Completion 2026-01-01
Interventions
Placebo oral tabletTrazodone Hydrochloride

Brief 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 Criteria

Inclusion Criteria: * Moderate-to-severe OSA (AHI ≥ 15 events/hr) Exclusion Criteria: * 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, uncontrol

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