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Can a pill replace the CPAP machine for sleep apnea?

NCT ID NCT05071612

Disease control Sponsor: Apnimed Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether two investigational drugs, AD109 and AD504, taken as a pill at bedtime, can reduce the number of breathing pauses in people with obstructive sleep apnea. The study compares these drugs against atomoxetine (an existing medication) and a placebo. Participants are adults with moderate sleep apnea, and the main goal is to see if the drugs lower the apnea-hypopnea index, a measure of breathing disruptions 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
Combination of investigational drugs AD109 and AD504, compared to atomoxetine and placebo, taken orally at bedtime.
What this could lead to
If successful, this could lead to a new oral medication option for obstructive sleep apnea, potentially offering an alternative to CPAP machines.
What could go wrong
This is an early-phase trial, so the drugs may not prove effective or safe. Possible side effects are not fully known, and results may not generalize to all patients.

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

294 people

The number who actually took part.

Started

Nov 2021

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 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: * Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit. * Mean AHI 10 to 45 events/h, inclusive * PGI-S: \>1 * BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive. Exclusion Criteria: * Current clinically significant sleep disorder other than OSA * Clinically significant craniofacial malformation. * Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control). * Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSA - obstructive sleep apnea

Contacts and locations

Locations

  • Bogan Sleep Consultants LLC

    Columbia, South Carolina, 29201, United States

  • Brian Abaluck, LLC

    Malvern, Pennsylvania, 19355, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Chicago Research Center

    Chicago, Illinois, 60634, United States

  • Clayton Sleep Institute

    Maplewood, Missouri, 63143, United States

  • Clinilabs

    New York, New York, 10016, United States

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562, United States

  • Delta Waves

    Colorado Springs, Colorado, 80918, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48377, United States

  • Intrepid Research

    Cincinnati, Ohio, 45245, United States

  • Minnesota Lung Center / Minnesota Sleep Institute

    Woodbury, Minnesota, 55125, United States

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Neurocare

    Newton, Massachusetts, 02459, United States

  • Pacific Research Network

    San Diego, California, 92103, United States

  • Research Centers of America -- Hollywood

    Hollywood, Florida, 33024, United States

  • SDS Clinical Trials, Inc.

    Santa Ana, California, 92705, United States

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025, United States

  • Sleep Disorders Centers of the Mid-Atlantic (SDCMA)

    Glen Burnie, Maryland, 21061, United States

  • Sleep Medicine Specialists of South Florida

    Miami, Florida, 33176, United States

  • Sleep and Attention Disorders Institute

    Sterling Heights, Michigan, 48314, United States

  • St. Luke's Hospital Sleep Medicine

    Chesterfield, Missouri, 63017, United States

  • Teradan Clinical Trials

    Brandon, Florida, 33511, United States

  • The Center for Sleep & Wake Disorders

    Chevy Chase, Maryland, 20815, United States

  • Velocity Clinical Research

    Greenville, South Carolina, 29615, United States

More trials for these conditions

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