Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 70Years
All Genders
NCT06286189

Trazodone on OSA Endotypes

Led by Brigham and Women's Hospital · Updated on 2025-02-06

18

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Trazodone on OSA Endotypes

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate-to-severe obstructive sleep apnea with an apnea-hypopnea index (AHI) of 15 or more events per hour
  • Age between 21 and 70 years
Not Eligible

You will not qualify if you...

  • Presence of major organ system diseases that prevent physiological measurements
  • Use of medications that stimulate or depress respiration, including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, or 4-hydroxybutanoic acid
  • Use of SSRIs or SNRIs
  • Neuromuscular diseases or major neurological disorders
  • Heart failure or other unstable major medical conditions
  • Sleep or respiratory disorders other than obstructive sleep apnea
  • Other sleep disorders such as periodic limb movements with arousal index over 10 per hour, narcolepsy, or parasomnias
  • Hypersensitivity to trazodone, including angioedema or urticaria
  • Contraindications to the DAW2020 device
  • Use of medications that lengthen QTc interval
  • Low potassium or magnesium levels, or uncontrolled thyroid disease
  • Severe claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

L

Ludovico Messineo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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