CompletedPhase 3
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
Key facts
- Who runs it
- Apnimed
- Where
- Abington, Anaheim, Ann Arbor, Atlanta, Austin, Brandon, Carlsbad, Cerritos, Charlotte, Chattanooga, Chicago, Chula Vista, Cincinnati, Cleveland, Cutler Bay, Dallas, DeLand, Denver, Elkridge, Fargo, Greenville, High Point, Hollywood, Houston, Huntsville, Kansas City, Lake Worth, Lathrup Village, Lehigh Acres, Little Rock, Louisville, Meridian, Mesa, Miami, Montclair, North Dartmouth, North Las Vegas, Orlando, Peoria, Phoenix, Red Oak, Riverside, Rock Hill, San Antonio, San Diego, San Ramon, Santa Ana, South Ogden, Suwanee, Tampa, Tempe, Thomasville, Tucson, Tuscaloosa, West Covina, West Long Branch, Wilmington, Winter Park, and Wyomissing, United StatesSee the 65 sitesAlso in 1 other country, 8 sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 646 people enrolled
- Started
- 16 Sept 2023
- Ended
- 14 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- AD109
- Placebo
- Record updated
- 11 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- ≥18 years of age at the time of informed consent
- PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
- PROMIS-Fatigue: raw score ≥17
- PAP intolerance or current PAP refusal
- BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive
Who cannot take part
- Narcolepsy, restless leg syndrome, REM sleep behavior disorder
- 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
- Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy
- Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed
- Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease
- -
Where in United States
Also in 1 other country, 8 sites
- Abington Neurological AssociateAbington, United StatesNo longer taking part
- Orange County Research InstituteAnaheim, United StatesNo longer taking part
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Atlanta Center for Medical Research, LLCAtlanta, United StatesNo longer taking part
- NeuroTrials ResearchAtlanta, United StatesNo longer taking part
- FutureSearch Trials of NeurologyAustin, United StatesNo longer taking part
- Meris Clinical ResearchBrandon, United StatesNo longer taking part
- North County Neurology AssociatesCarlsbad, United StatesNo longer taking part
- Core Healthcare GroupCerritos, United StatesNo longer taking part
- Javara Inc - Tryon Medical Partners PLCCCharlotte, United StatesNo longer taking part
- Chattanooga Research & Medicine, PLLCChattanooga, United StatesNo longer taking part
- Chicago Research Center Inc.Chicago, United StatesNo longer taking part
- Exalt Clinical ResearchChula Vista, United StatesNo longer taking part
- CTI Clinical Research CenterCincinnati, United StatesNo longer taking part
- Sleep Management Institute (Intrepid)Cincinnati, United StatesNo longer taking part
- UC Health Sleep MedicineCincinnati, United StatesNo longer taking part
- University Hospital of Cleveland Medical CenterCleveland, United StatesNo longer taking part
- Nouvelle Clinical ResearchCutler Bay, United StatesNo longer taking part
- FutureSearch Trials of Dallas, LPDallas, United StatesNo longer taking part
- DeLand, FloridaHospital not named in the registryNo longer taking part
- Research Carolina EliteDenver, United StatesNo longer taking part
- Centennial Medical GroupElkridge, United StatesNo longer taking part
- Lillestol Research, LLCFargo, United StatesNo longer taking part
- Tribe Clinical Research LLGreenville, United StatesNo longer taking part
- Peters Medical Research, LLCHigh Point, United StatesNo longer taking part
- Research Centers of America, LLCHollywood, United StatesNo longer taking part
- Lone Star Lung and Sleep ClinicHouston, United StatesNo longer taking part
- The Heights Hospital (HD Heights)Houston, United StatesNo longer taking part
- Weill Cornell Medical CollegeHouston, United StatesNo longer taking part
- Huntsville Research Institute, LLCHuntsville, United StatesNo longer taking part
- The University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Canvas Clinical ResearchLake Worth, United StatesNo longer taking part
- Revive Research InstituteLathrup Village, United StatesNo longer taking part
- Florida Lung and Sleep AssociatesLehigh Acres, United StatesNo longer taking part
- Preferred Research Partners, IncLittle Rock, United StatesNo longer taking part
- Advanced ENT and AllergyLouisville, United StatesNo longer taking part
- St. Lukes Clinic - Idaho Pulmonary AssociatesMeridian, United StatesNo longer taking part
- Desert Clinical Research/CCT ResearchMesa, United StatesNo longer taking part
- Advanced Medical Research InstituteMiami, United StatesNo longer taking part
- Clinical Site PartnersMiami, United StatesNo longer taking part
- Catalina Research InstituteMontclair, United StatesNo longer taking part
- Infinity Medical ResearchNorth Dartmouth, United StatesNo longer taking part
- Las Vegas Clinical TrialsNorth Las Vegas, United StatesNo longer taking part
- Clinical Neuroscience Solutions, Inc - OrlandoOrlando, United StatesNo longer taking part
- OSF HealthCare Saint Francis Medical CenterPeoria, United StatesNo longer taking part
- Foothills Research Center Cct ResearchPhoenix, United StatesNo longer taking part
- Epic Medical ResearchRed Oak, United StatesNo longer taking part
- Probe Clinical Research CorporationRiverside, United StatesNo longer taking part
- OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.ARock Hill, United StatesNo longer taking part
- Element Research GroupSan Antonio, United StatesNo longer taking part
- Pacific Research NetworkSan Diego, United StatesNo longer taking part
- Sleep Medicine Specialists of CaliforniaSan Ramon, United StatesNo longer taking part
- SDS Clinical Trials, Inc.Santa Ana, United StatesNo longer taking part
- South Ogden Family Medicine/CCT ResearchSouth Ogden, United StatesNo longer taking part
- Georgia Neurology and Sleep Medicine AssocSuwanee, United StatesNo longer taking part
- JSV Clinical Research Study IncTampa, United StatesNo longer taking part
- Fiel Family Sports Medicine - PC CCT ResearchTempe, United StatesNo longer taking part
- Javarra Inc-Privia Medical GroupThomasville, United StatesNo longer taking part
- Noble Clinical ResearchTucson, United StatesNo longer taking part
- Alabama Neurology & Sleep MedicineTuscaloosa, United StatesNo longer taking part
- Providere Research IncWest Covina, United StatesNo longer taking part
- Neurology Specialists of Monmouth CountyWest Long Branch, United StatesNo longer taking part
- PMG Research of WilmingtonWilmington, United StatesNo longer taking part
- Florida Pediatric Research InstituteWinter Park, United StatesNo longer taking part
- Respiratory SpecialistsWyomissing, United StatesNo longer taking part
About the trial
What the trial wants to find out
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
The 2 groups in the trial
- AD109Treatment being tested
- PlaceboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)
- Publications
- Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy).American journal of respiratory and critical care medicine, 2026
- Record updated
- 11 September 2026