Sleep apnea combo therapy shows promise in early trial
NCT ID NCT07577661
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
This study tests whether combining a nerve-stimulating implant with two medications (atomoxetine and oxybutynin) can improve breathing during sleep more than either treatment alone. Twenty-four adults with obstructive sleep apnea who already have the implant will try each combination in random order. The goal is to see if the combo reduces breathing pauses better than the implant or medication by itself.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hypoglossal nerve stimulation device and atomoxetine plus oxybutynin
- What this could lead to
- If it works, this could point toward a more effective treatment for obstructive sleep apnea that combines a device and medication.
- What could go wrong
- This is a very small, early-phase trial with only 24 people. The combination may not work better than either treatment alone, and the medications can cause side effects like dry mouth or dizziness.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Sep 2028
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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18 to 79 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 for Enrolment: * Ages 18 - 79 years * Diagnosed OSA * Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization) * Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off \[with/without pharmacotherapy\] to assess benefits of HGNS therapy). Exclusion Criteria: * Any uncontrolled medical condition * Current use of the medications under investigation. * Issues relating to short-term withdrawal of HGNS therapy * Excluded: Occupational driving (truck drivers, fork-lift operation, taxi/uber drivers) * Excluded: History of traffic accidents attributable to sleepiness or fatigue (\<2 years). * Use of SNRIs/SSRIs or anticholinergic medications during the study. * Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition. * Respiratory disorders other than sleep disordered breathing: chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * Other sleep disorders: narcolepsy, parasomnias. Insomnia * Contraindications for atomoxetine and oxybutynin, including: * hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria) * pheochromocytoma * use of monoamine oxidase inhibitors * diagnosed benign prostatic hypertrophy, urinary retention * suspected benign prostatic hypertrophy / urinary retention based on a positive answer to either of the following questions: 1. "During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?" 2. "During the last month, have you had a weak urinary stream more often than 1 out of 5 times? * known untreated narrow angle glaucoma * known bipolar disorder, mania, psychosis * known history of major depressive disorder (age\<24). * known history of attempted suicide or suicidal ideation within one year prior to screening * known clinically significant constipation, gastric retention * known pre-existing seizure disorders * known clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2) * known clinically-significant liver disorders * known clinically-significant cardiovascular conditions * moderate-to-severe hypertension (SBP\>160 mmHg or DBP\>100 mmHg measured at baseline; average of evening and morning measures) * known cardiomyopathy (LVEF\<50%) or heart failure * known advanced atherosclerosis * recent cerebrovascular events (within 2 years) * recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years) * other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate * myasthenia gravis * 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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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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