Recruiting
Phase 1
Phase 2

Trazodone

Sponsor:

Brigham and Women's Hospital

Code:

NCT06286189

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Placebo oral tablet

Trazodone Hydrochloride

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06286189

Start date

Jan 1, 2024

Status verified date

Feb, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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, uncontrolled thyroid disease
  • Severe claustrophobia.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo capsule 30 min before sleep

experimental: Trazodone

Trazodone capsule 30 min before sleep

Interventions

Placebo oral tablet

Placebo capsule taken 30 min before sleep

Trazodone Hydrochloride

Trazodone 100 mg 30 min before sleep

Primary outcome measure

  • Effect of trazodone on arousal threshold (%eupnea) [ Time Frame: 1 night ]

Central Contacts and Locations

Central contacts

Ludovico Messineo

(617) 732-4013lmessineo@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Nicole Calianese, BS

617-732-8976ncalianese@mgb.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-02-06.