Comparing treatments for obstructive sleep apnea in adults
Compares PAP, dental device and atomoxetine-oxybutynin for obstructive sleep apnea.
Key facts
- Who runs it
- Sairam Parthasarathy
- Where
- Baltimore, Miami, Redwood City, and Tucson, United StatesSee the 4 sites
- Trial code
- Registry title
- A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 2,400 people, planned
- Started
- 4 Sept 2026
- Expected to end
- 1 May 2032
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Positive airway pressure (PAP) therapy
- Sleep dental device
- Atomoxetine-oxybutynin
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults recently diagnosed with obstructive sleep apnea, where the airway closes during sleep. Each person gets one of three treatments by chance: PAP therapy, a dental device, or the drugs atomoxetine and oxybutynin.
- Age
- 18 Years and older
- Sex
- All
- Disease stage
- Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months. People need two or more of these symptoms: snoring, broken sleep, breathing stops that others notice, or daytime sleepiness.
- Earlier treatment
- People cannot join if they were treated for sleep apnea in the past year. They must be willing and able to use any of the 3 treatments. They must have health insurance of any type.
Main reasons for not taking part
- Central sleep apnea or narcolepsy
- Jaw joint problems, severe gum disease or too few teeth for a dental device
- Heart failure with ejection fraction of </= 45%, or angina or heart attack within 3 months
- Untreated depression, narrow angle glaucoma or underactive thyroid, liver disease, seizures, or major stomach or urine retention
- Pregnant, nursing or planning pregnancy within the year, or taking medicines that cannot be combined with atomoxetine or oxybutynin
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
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
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Positive airway pressure (PAP) therapyExisting treatment, for comparison
Participants will use a PAP machine to treat their obstructive sleep apnea.
- Dental deviceExisting treatment, for comparison
Participants will use a sleep dental device to treat their obstructive sleep apnea.
Treatment: Sleep dental device
- Medications - atomoxetine-oxybutyninExisting treatment, for comparison
Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
Treatment: Atomoxetine-oxybutynin
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study
- Plain-language title
- Comparing treatments for obstructive sleep apnea in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 19 October 2026