Scientists uncover how two drugs team up to fight sleep apnea
NCT ID NCT05944965
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two drugs, atomoxetine and oxybutynin, affect throat muscles in people with obstructive sleep apnea (OSA). The goal was to understand why the combination works better than either drug alone. 27 adults with OSA took part, and researchers measured muscle activity during sleep. The findings help explain the mechanism behind this potential new treatment.
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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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27 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jun 2025
- 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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Accepted
You do not need to have the condition being studied to take part.
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: * diagnosed OSA (AHI≥15 events/h reported in PSG performed within one year) or Suspected OSA (snoring, sleepiness, witness apneas, other clinical symptoms) * not using CPAP (\>1 week) Exclusion Criteria: * Any uncontrolled medical condition * Current use of the medications under investigation * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid). * Current use of SNRIs/SSRIs or anticholinergic medications. * 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: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias. * 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: * "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?" * "During the last month, have you had a weak urinary stream more often than 1 out of 5 times? * untreated narrow angle glaucoma * bipolar disorder, mania, psychosis * history of major depressive disorder (age\<24). * history of attempted suicide or suicidal ideation within one year prior to screening * clinically significant constipation, gastric retention * pre-existing seizure disorders * clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2) * 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 atherosclerosis * 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 * Allergy to lidocaine * Use of oral anti-coagulants * Claustrophobia * Pregnancy or nursing
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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.
Contacts and locations
Locations
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Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a sleep apnea machine keep heart patients out of the hospital?
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- Can a smartwatch and app boost CPAP use in heart patients?
- New implant could help sleep apnea patients ditch the CPAP mask
- Sleep apnea treatment may also help your mouth and swallowing