What this study is
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.
What's being tested
- Positive airway pressure (PAP) therapy
Intervention · DEVICE
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
- Sleep dental device
Intervention · DEVICE
An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
- Atomoxetine-oxybutynin
Intervention · DRUG
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Study details
- Official title
- Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study
- Sponsor
- Sairam Parthasarathy
- Conditions
- Obstructive Sleep Apnea (OSA)
- Enrolling
- 2,400 people
- Starts
- 2026-09-04
- Est. completion
- 2032-05-01
- Design
- Single-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Prior treatment for OSA in past year
- Central sleep apnea or narcolepsy
- Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)
- Heart failure with reduced ejection fraction of </= 45%
- Active coronary artery disease (angina or infarction within 3 months of enrollment)
- Current untreated depression
- Untreated narrow angle glaucoma
- Untreated hypothyroidism
- Clinically significant gastric retention
- Clinically significant urinary retention
- History of liver disease
- Seizure disorder
- Pregnant or nursing, or plans to become pregnant within the year
- Concomitant medication use that is incompatible with atomoxetine or oxybutynin
- Participation in another clinical study with an investigational product
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (4)
4 openBanner University Medical Center Tucson
Tucson, Arizona, United States
- Nayeli Lopez · Contact1-520-621-6756ADAPT-OSAstudy@arizona.edu
- Saif Mashaqi, MD · Sub-investigator
- Monisha Das Ireland, MD · Sub-investigator
- Sairam Parthasarathy, MD · Principal investigator
RecruitingStanford Medical Center
Redwood City, California, United States
- Clete Kushida, MD, PhD · Contact650-721-7560clete@stanford.edu
- Clete Kushida, MD, PhD · Principal investigator
RecruitingUniversity of Miami Miller School of Medicine
Miami, Florida, United States
- Nina L'Houtellier · Contact1-305-689-1358nvl15@med.miami.edu
- Girardin Jean-Louis, PhD · Principal investigator
- Alexandre Abreu, MD · Sub-investigator
Not yet recruitingUniversity of Maryland Baltimore
Baltimore, Maryland, United States
- Christine Johnston · Contact1-410-706-1486christine.johnston@som.umaryland.edu
- Emerson Wickwire, PhD · Principal investigator
Recruiting
Study team
Sponsor
Sairam Parthasarathy
Study ID BPS-2024C2-37819
Principal investigator
Sairam Parthasarathy, MD
University of Arizona
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.