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Taking people in United StatesPhase 1/2

Trazodone for obstructive sleep apnea and how it affects breathing during sleep

Tests trazodone taken before sleep in people with obstructive sleep apnea.

Key facts

Who runs it
Brigham and Women's Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Trazodone on OSA Endotypes
Status
Recruiting
Phase
Phase 1/2
People taking part
18 people, planned
Started
1 Jan 2024
Planned end
1 Jun 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo oral tablet
  • Trazodone Hydrochloride
Record updated
6 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate-to-severe obstructive sleep apnea, where the airway closes again and again during sleep. It tests trazodone taken before sleep against a placebo (dummy pill).

Age
21 Years to 70 Years
Sex
All sexes can join.
Disease stage
Moderate-to-severe obstructive sleep apnea (AHI ≥ 15 events/hr, meaning at least 15 breathing pauses or shallow-breathing events per hour of sleep).
Earlier treatment
People cannot join if they use medicines that speed up or slow down breathing (such as opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid), SNRIs/SSRIs, or medicines that lengthen the QTc interval.

Main reasons for not taking part

  • Major organ disease, neuromuscular or major neurological disease, heart failure, or another unstable major medical condition.
  • Breathing problems during sleep, or lung and breathing disorders, other than obstructive sleep apnea.
  • Other sleep disorders: periodic limb movements (arousal index > 10/hr), narcolepsy, or parasomnias.
  • Allergy to the study drug (angioedema or urticaria), or contraindications to DAW2020.
  • Low potassium, low magnesium, uncontrolled thyroid disease, or severe claustrophobia.

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Who cannot take part

  • Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid)
  • All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements
  • 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)
  • Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
  • Use of medications that lengthen QTc interval
  • Use of SNRIs/SSRIs
  • Contraindications to DAW2020
  • Severe claustrophobia

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 70 years old?

Where in United States

  • Brigham and Women's HospitalBoston, United StatesContact: Nicole Calianese, BSTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    Placebo capsule 30 min before sleep

    Treatment: Placebo oral tablet

  • TrazodoneTreatment being tested

    Trazodone capsule 30 min before sleep

    Treatment: Trazodone Hydrochloride

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
Plain-language title
Trazodone for obstructive sleep apnea and how it affects breathing during sleepGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06286189, who can take part
Record updated
6 February 2025