RecruitingPhase 1Phase 2NCT05293600

Rescue Pharmacotherapy for OSA

Treating Residual OSA With Endotype-directed Pharmacotherapy (Aim 3)


Sponsor

Brigham and Women's Hospital

Enrollment

70 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.


Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetazolamide, a drug called Atomoxetine and eszopiclone, and others for people with obstructive sleep apnea. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Placebo capsule 30 min before bedtime

DRUGAcetazolamide

The intervention drug will be determined based on altered endotype and administered 30 min before bedtime. Patients will only take one drug of this intervention, which will be subsequently compared to placebo. Patients with increased loop gain will be given Acetazolamide 500 mg.

DRUGTrazodone

The intervention drug will be determined based on altered endotype and administered 30 min before bedtime. Patients will only take one drug of this intervention, which will be subsequently compared to placebo. Patients with decreased arousal threshold will be given Trazodone 100 mg.

DRUGAtomoxetine and eszopiclone

The intervention drug will be determined based on altered endotype and administered 30 min before bedtime. Patients will only take one drug of this intervention, which will be subsequently compared to placebo. Patients with decreased muscle responsiveness will be given Atomoxetine and Eszopiclone 80 + 3 mg.


Locations(1)

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT05293600


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