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Sleep apnea pill shows promise in phase 3 trial

NCT ID NCT05811247

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medication called AD109 (a combination of two drugs) to treat obstructive sleep apnea in adults who cannot or will not use a CPAP machine. About 660 participants took either the pill or a placebo for one year. The main goal was to see if the pill reduces the number of breathing pauses during sleep. The trial has been completed, and results will show if this pill can ease sleep apnea symptoms.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

660 people

The number who actually took part.

Started

Aug 2023

Finished

May 2025

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 years and older

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: 1. ≥18 years of age at the time of informed consent. 2. PSG criteria: AHI of \>5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15 3. PROMIS-Fatigue: raw score ≥17 4. PAP intolerance or current PAP refusal. 5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive. Exclusion Criteria: 1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder 2. Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms. 3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy. 4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed. 5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

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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

Contacts and locations

Locations

  • Advanced Respiratory and Sleep Medicine, LLC

    Huntersville, North Carolina, 28078, United States

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301, United States

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117, United States

  • Baystate Medical Center (BMC) - Baystate Sleep Medicine

    Springfield, Massachusetts, 01199, United States

  • Brian Abaluck, LLC

    Malvern, Pennsylvania, 19355, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • CenExel CNS

    Los Alamitos, California, 90720, United States

  • CenExel iResearch

    Decatur, Georgia, 30030, United States

  • Cenexel Research Centers of America - Hollywood

    Hollywood, Florida, 33024, United States

  • Central Texas Neurology Consultants, PA

    Round Rock, Texas, 78681, United States

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31326, United States

  • Chandler Clinical Trials

    Chandler, Arizona, 85224, United States

  • Chicago Research Center Inc

    Chicago, Illinois, 60634, United States

  • Clayton Sleep Institute

    St Louis, Missouri, 63123, United States

  • Clinical Neurophysiology Services

    Sterling Heights, Michigan, 48314, United States

  • Clinical Neuroscience Solutions - Memphis

    Memphis, Tennessee, 38119, United States

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789, United States

  • Clinilabs, Inc

    Eatontown, New Jersey, 07724, United States

  • Coastal Carolina Health Care

    New Bern, North Carolina, 28562, United States

  • Empire Clinical Research

    Pomona, California, 91767, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Great Plains Health

    North Platte, Nebraska, 69101, United States

  • Healthcare Research Network

    Hazelwood, Missouri, 63042, United States

  • Henderson Clinical Trials

    Henderson, Nevada, 89052, United States

  • Henry Ford Health (Sleep Research Department)

    Novi, Michigan, 48377, United States

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747, United States

  • Ivetmar Medical Group LLC

    Miami, Florida, 33155, United States

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406, United States

  • Maimonides Sleep Arts and Sciences

    Albuquerque, New Mexico, 87107, United States

  • Marvel Clinical Research, LLC

    Huntington Beach, California, 92647, United States

  • Medster Research

    Valdosta, Georgia, 31605, United States

  • Meridian Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209, United States

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718, United States

  • NeuroTrials Research

    Atlanta, Georgia, 30328, United States

  • Neurocare, Inc

    Newton, Massachusetts, 02459, United States

  • Northwell Health Physician Partners

    New Hyde Park, New York, 11042, United States

  • Northwest Research Center

    Portland, Oregon, 97202, United States

  • Nouvelle Clinical Research

    Cutler Bay, Florida, 33189, United States

  • Nuvance Health

    Norwalk, Connecticut, 06850, United States

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017, United States

  • Orange County Research Institute

    Anaheim, California, 92801, United States

  • Pacific Research Network

    San Diego, California, 92103, United States

  • Palm Beach Research ClinEdge-PPDS

    West Palm Beach, Florida, 33409, United States

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Research Carolina Elite

    Denver, North Carolina, 28037, United States

  • SDS Clinical Trials Inc.

    Santa Ana, California, 92705, United States

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025, United States

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213, United States

  • Sleep Disorders Centers of the Mid-Atlantic

    Glen Burnie, Maryland, 21061, United States

  • Sleep Disorders Centers of the Mid-Atlantic

    Vienna, Virginia, 22182, United States

  • Sleep Management Institute

    Cincinnati, Ohio, 45245, United States

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210, United States

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229, United States

  • St Lukes Hospital

    Chesterfield, Missouri, 63017, United States

  • St. Francis Medical Institute

    Clearwater, Florida, 33765, United States

  • Teradan Clinical trials LLC

    Brandon, Florida, 33511, United States

  • UPMC Comprehensive Lung Center - Sleep Medicine

    Pittsburgh, Pennsylvania, 15213, United States

  • Velocity Clinical Research

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research - Greenville

    Greenville, South Carolina, 29615, United States

  • Western Michigan University Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49008, United States

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