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Rescue Pharmacotherapy for Obstructive Sleep Apnea

This study is for people with Obstructive Sleep Apnea (OSA) whose current treatments, like a mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS), haven't fully worked. Researchers want to see if adding a specific drug can help. You would receive either a placebo (inactive pill) or one of three drugs: Acetazolamide, Trazodone, or a combination of Atomoxetine and Eszopiclone. The drug you receive depends on your specific type of OSA. The main goal is to see if these drugs can reduce the Apnea Hypopnea Index (AHI), which measures how often your breathing stops or gets shallow during sleep. The study aims to enroll 70 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 70 participants, comparing active drugs to a placebo.
What's involved
You would take a capsule 30 minutes before bedtime. The primary endpoint, Apnea Hypopnea Index, is measured after one night.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at one night, suggesting a short follow-up period.

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NCT05293600

Rescue Pharmacotherapy for OSA

Recruiting
PHASE1Ages 21–70InterventionalTreatment
Brigham and Women's Hospital
~70 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:PlaceboAcetazolamideTrazodoneAtomoxetine and eszopiclone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Measured over 1 night

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

David Andrew Wellman, MD
[email protected]
5089827401
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.

Exclusion

Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
Any unstable major medical condition.
Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Use of SSRIs/SNRIs.
Contraindications for atomoxetine, including:
pheochromocytoma
use of monoamine oxidase inhibitors
benign prostatic hypertrophy, urinary retention
untreated narrow angle glaucoma
bipolar disorder, mania, psychosis
clinically significant constipation, gastric retention
pre-existing seizure disorders
clinically-significant kidney disorders
clinically-significant liver disorders
clinically-significant cardiovascular conditions
severe hypertension (SBP\>180 mmHg or DBP\>110 mmHg measured at baseline)
cardiomyopathy (LVEF\<50%) or heart failure
advanced atherosclerosi
history of cerebrovascular events
history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
myasthenia gravis
pregnancy/breast-feeding
Contraindications for eszopiclone, including:
Hypersensitivity to eszopiclone
Chronic Obstructive Pulmonary Disease (COPD)
Pregnancy
Breast feeding
Liver disease
Contraindications for acetazolamide, including:
Hyperchloremic acidosis
Hypokalemia
Hyponatremia
Adrenal insufficiency
Impaired kidney function
Hypersensitivity to acetazolamide or other sulfonamides.
Marked liver disease or impairment of liver function, including cirrhosis.
Contraindications for trazodone, including:
suicidal ideation
bipolar disorder, mania
use of monoamine oxidase inhibitors
coronary artery disease
cardiac arrhythmias
QT prolongation
hepatic disease
renal failure or impairment
closed angle glaucoma
priapism
pregnancy/breast-feeding

What this trial measures

  • Apnea Hypopnea Index (AHI, Events/Hour of Sleep)1 night

    Based on previous studies the investigators anticipate that the interventional arm will reduce AHI through a positive effect on the abnormal endotype.