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Trazodone for Obstructive Sleep Apnea

Phase 1 & 2
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Be older than 18 years old
Must not have
Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure, or any other unstable major medical condition
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 night

Summary

This trial aims to test if giving trazodone before sleep can help improve symptoms and severity of obstructive sleep apnea by allowing the upper airway muscles to work effectively during sleep.

Who is the study for?
This trial is for individuals with Obstructive Sleep Apnea (OSA), particularly those who wake up too early during an obstructive event, preventing their airway muscles from responding properly. Specific eligibility criteria are not provided.
What is being tested?
The study tests the effect of Trazodone Hydrochloride, a medication given before sleep, on OSA severity and traits compared to a placebo. The goal is to see if Trazodone can improve sleep quality in OSA patients.
What are the potential side effects?
While specific side effects for this trial aren't listed, common side effects of Trazodone may include drowsiness, dizziness, constipation, blurred vision, and dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate-to-severe sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major neurological disorders, heart failure, or other unstable conditions.
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I have a sleep or breathing disorder that is not obstructive sleep apnea.
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I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.
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I do not have any major organ disease that would prevent me from undergoing tests.
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I am not taking medications that affect my breathing.
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I am taking medication that affects my heart's electrical cycle.
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I am not allergic or unable to take DAW2020 due to health reasons.
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I do not have low potassium, low magnesium, or uncontrolled thyroid issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 night
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of trazodone on arousal threshold (%eupnea)
Secondary study objectives
Effect of trazodone on apnea hypopnea index (events/h)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TrazodoneExperimental Treatment1 Intervention
Trazodone capsule 30 min before sleep
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule 30 min before sleep

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,606 Total Patients Enrolled
~1 spots leftby Jan 2025
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