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Pill power: new drug combo may ease sleep apnea without a mask

NCT ID NCT03919955

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tested a combination of two drugs, atomoxetine and oxybutynin (called AtoOxy), as a potential pill-based treatment for obstructive sleep apnea (OSA). 117 adults with OSA who were not using CPAP took the medication for one month. The goal was to see if the drug combo could reduce breathing pauses during sleep and improve daytime sleepiness, and to identify which patients benefit most.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

117 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2023

Lead sponsor

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

21 to 70 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Ages 21-70 years * Diagnosed OSA or clinically-suspected OSA * Not using CPAP (\>1 month). 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 hypnotic medications (trazodone, eszopiclone, benzodiazepines). * 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 study drugs (angioedema or urticaria) * pheochromocytoma * use of monoamine oxidase inhibitors * benign prostatic hypertrophy, urinary retention * 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 (Aim 2 only) * 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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.