Personalized pills may rescue sleep apnea patients failed by standard devices
NCT ID NCT05293600
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study tests whether adding a drug tailored to a person's specific sleep apnea subtype can help when a mouthpiece or tongue nerve stimulator still leaves them with breathing pauses. Participants whose device did not fully control their apnea will receive either a placebo or one of three drugs—acetazolamide, trazodone, or atomoxetine-plus-eszopiclone—chosen based on their individual sleep apnea cause. The goal is to see if the drug can further reduce the number of breathing interruptions during sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acetazolamide, trazodone, or atomoxetine-plus-eszopiclone depending on the person's sleep apnea subtype
- What this could lead to
- If successful, this could offer a drug-based rescue option for people whose mouthpiece or nerve stimulator does not fully control their sleep apnea.
- What could go wrong
- This is an early-phase trial with only 70 participants, so results may not apply to everyone. The drugs also have side effects and may not work for all subtypes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy. Exclusion Criteria: * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sleep Disorders Research Program Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Hypercapnic burden in adults with obesity undergoing diagnostic polysomnography for suspected obstructive sleep apnea: a prospective observational cohort study
- Real-world evaluation of the clinical performance and safety of apneal dx for the screening and aid in the diagnosis of obstructive sleep apnea-hypopnea syndrome in adults: a post-market clinical follow-up study
- Can a small breathing hurdle ease sleep apnea?
- Can a weekly shot ease sleep apnea in obesity?
- Can a Mini-Dose drug combo rescue Post-Surgery sleep for sleep apnea patients?
- Could a treadmill tame sleep apnea and calm brain inflammation?