Effect of Trazodone on Obstructive Sleep Apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of trazodone on patients with obstructive sleep apnea (OSA) by conducting two overnight home sleep studies, one with trazodone and one with a placebo. Participants will be monitored using full polygraphy to assess sleep and respiratory events without the use of CPAP. Trazodone will be administered 30 minutes before sleep to evaluate its effects on OSA traits and severity. A washout period will allow for a crossover to the alternative treatment after the initial study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Ludovico Messineo
• Email: lmessineo@bwh.harvard.edu
• Phone: (617) 732-4013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.