A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
Key facts
- Where
- Baltimore, Miami, Redwood City, and Tucson, United StatesSee the 4 sites
- Phase
- Phase 4
Where in United States
- University of Maryland, BaltimoreBaltimore, United StatesContact: Christine JohnstonTaking people
- University of Miami Miller School of MedicineMiami, United StatesContact: Nina L'HoutellierNot yet recruiting
- Stanford Medical CenterRedwood City, United StatesContact: Clete Kushida, MD, PhDTaking people
- Banner University Medical Center - TucsonTucson, United StatesContact: Nayeli LopezTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sairam Parthasarathy
- Trial code
- NCT07679282
- Record updated
- 19 October 2026
- Original description
Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.Read full original descriptionShow less
Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study
Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.
Inclusion: Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months; Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness; Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin); Health insurance of any type.
Exclusion: Prior treatment for OSA in past year; Concomitant medication use that is incompatible with atomoxetine or oxybutynin; Participation in another clinical study with an investigational product; Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition); Active coronary artery disease (angina or infarction within 3 months of enrollment); History of liver disease; Seizure disorder; Heart failure with reduced ejection fraction of </= 45%; Central sleep apnea or narcolepsy; Current untreated depression; Untreated narrow angle glaucoma; Untreated hypothyroidism; Clinically significant gastric retention; Clinically significant urinary retention; Pregnant or nursing, or plans to become pregnant within the year.