Trazodone on OSA Endotypes

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID: NCT06286189
Run by: Brigham and Women's Hospital
People needed: 18
Starts: 2024-01-01
Expected to finish: 2026-06-01
Last updated by the study team: 2025-02-06

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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