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NCT Number: NCT06286189

Trazodone on OSA Endotypes

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Nicole Calianese, BS

CONTACT

[email protected]

617-732-8976

About this study

Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oral tablet

Drug

Placebo capsule taken 30 min before sleep

Trazodone Hydrochloride

Drug

Trazodone 100 mg 30 min before sleep

Primary outcomes

  1. Effect of trazodone on arousal threshold (%eupnea)

    Time frame: 1 night

    Arousal threshold will be calculated non invasively from the home sleep test flow signal

Secondary outcomes

  1. Effect of trazodone on apnea hypopnea index (events/h)

    Time frame: 1 night

    Apnea hypopnea index will be calculated from the home sleep test

Study contacts

Contact information is provided by the study sponsor or research team.

Ludovico Messineo

CONTACT

[email protected]

(617) 732-4013

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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