Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a pill replace the CPAP machine for sleep apnea?

NCT ID NCT05813275

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study tested a new combination pill called AD109 for obstructive sleep apnea (OSA) in 646 adults who could not tolerate CPAP machines. The pill aims to reduce breathing pauses during sleep by targeting brain chemicals. Results will show if it improves the apnea-hypopnea index (AHI) compared to a placebo over 6 months.

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

646 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 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 ≥10 and ≤45; ≤ 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. Exclusion Criteria: \-

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for OSA are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • AMNDX

    Markham, Ontario, L3R 1A3, Canada

  • Abington Neurological Associate

    Abington, Pennsylvania, 19001, United States

  • Accel Research Sites

    DeLand, Florida, 32720, United States

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40220, United States

  • Advanced Medical Research Institute

    Miami, Florida, 33174, United States

  • Alabama Neurology & Sleep Medicine

    Tuscaloosa, Alabama, 35406, United States

  • Atlanta Center for Medical Research, LLC

    Atlanta, Georgia, 30031, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2, Canada

  • Canadian Sleep Consultants

    Calgary, Alberta, T2Z 3R6, Canada

  • Canvas Clinical Research

    Lake Worth, Florida, 33467, United States

  • Catalina Research Institute

    Montclair, California, 91763, United States

  • Centennial Medical Group

    Elkridge, Maryland, 21075, United States

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404, United States

  • Chicago Research Center Inc

    Chicago, Illinois, 60634, United States

  • Clinical Neuroscience Solutions, Inc - Orlando

    Orlando, Florida, 32801, United States

  • Clinical Site Partners

    Miami, Florida, 33186, United States

  • Core Healthcare Group

    Cerritos, California, 90703, United States

  • Desert Clinical Research - CCT Research

    Mesa, Arizona, 85213, United States

  • Element Research Group

    San Antonio, Texas, 78229, United States

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • Exalt Clinical Research

    Chula Vista, California, 91910, United States

  • Fiel Family Sports Medicine - PC CCT Research

    Tempe, Arizona, 85283, United States

  • Florida Lung and Sleep Associates

    Lehigh Acres, Florida, 33971, United States

  • Florida Pediatric Research Institute

    Winter Park, Florida, 32789, United States

  • Foothills Research Center - CCT Research

    Phoenix, Arizona, 85044, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia, 30024, United States

  • Huntsville Research Institute LLC

    Huntsville, Texas, 77340, United States

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747, United States

  • JSV Clinical Research Study Inc

    Tampa, Florida, 33634, United States

  • Javara Inc - Tryon Medical Partners PLCC

    Charlotte, North Carolina, 28210, United States

  • Javarra Inc-Privia Medical Group

    Thomasville, Georgia, 31792, United States

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030, United States

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • Lone Star Lung and Sleep Clinic

    Houston, Texas, 77070, United States

  • McGill University Health Centre

    Montreal, Quebec, QC H4A, Canada

  • Medical Arts Health Research

    Kelowna, British Columbia, V1Y 9N7, Canada

  • Meris Clinical Research

    Brandon, Florida, 33511, United States

  • NeuroTrials Research

    Atlanta, Georgia, 30342, United States

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • North County Neurology Associates

    Carlsbad, California, 92011, United States

  • Nouvelle Clinical Research

    Cutler Bay, Florida, 33189, United States

  • OSF HealthCare Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A

    Rock Hill, South Carolina, 29732, United States

  • Orange County Research Institute

    Anaheim, California, 92801, United States

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401, United States

  • Pacific Research Network

    San Diego, California, 92103, United States

  • Peters Medical Research, LLC

    High Point, North Carolina, 27260, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Probe Clinical Research Corporation

    Riverside, California, 92501, United States

  • Provideré Research Inc.

    West Covina, California, 91790, United States

  • Research Carolina Elite

    Denver, North Carolina, 28025, United States

  • Research Centers of America, LLC

    Hollywood, Florida, 33024, United States

  • Respiratory Specialists

    Wyomissing, Pennsylvania, 19610, United States

  • Revive Research Institute

    Lathrup Village, Michigan, 48076, United States

  • SDS Clinical Trials Inc.

    Santa Ana, California, 92705, United States

  • Sleep Management Institute (Intrepid)

    Cincinnati, Ohio, 45245, United States

  • Sleep Medicine Specialists of California

    San Ramon, California, 94583, United States

  • Sleep and Alertness Center

    Toronto, Ontario, M5S 3A3, Canada

  • South Ogden Family Medicine / CCT Research

    South Ogden, Utah, 84405, United States

  • St. Lukes Clinic - Idaho Pulmonary Associates

    Meridian, Idaho, 83642, United States

  • The Heights Hospital (HD Heights)

    Houston, Texas, 77008, United States

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Toronto Sleep Institute

    Toronto, Ontario, M4P 1P2, Canada

  • Tribe Clinical Research LL

    Greenville, South Carolina, 29607, United States

  • UC Health Sleep Medicine

    Cincinnati, Ohio, 45267, United States

  • University Hospital of Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Weill Cornell Medical College

    Houston, Texas, 77030, United States

  • West Ottawa Sleep Centre

    Ottawa, Ontario, K2C 0P7, Canada

More trials for these conditions

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