Trazodone on OSA Endotypes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06286189
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo oral tablet — DRUG
    Placebo capsule taken 30 min before sleep
  • Trazodone Hydrochloride — DRUG
    Trazodone 100 mg 30 min before sleep

Study Details

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 Dates

Start date
Jan 1, 2024
Status verified
Feb 2025
Primary completion
Jan 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo capsule 30 min before sleep
  • Experimental: Trazodone
    Trazodone capsule 30 min before sleep

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Nicole Calianese, BS
[email protected]
617-732-8976

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By research site
Brigham and Women's Hospital· Boston, MA

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