NCT07679282 · Sairam Parthasarathy
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
(ADAPT-OSA)
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
Positive airway pressure (PAP) therapy
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
DEVICE
Sleep dental 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.
DRUG
Atomoxetine-oxybutynin
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Primary outcome measures
Health-related quality of life
Time frame: At 12 months
To compare the effectiveness of positive airway pressure (PAP) therapy versus dental device versus atomoxetine-oxybutynin for key patient centered outcomes in improving health-related quality of life over 12 months, as assessed by the PROMIS-29 v2.0.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Tucson, Arizona
- Redwood City, California
- Miami, Florida
- Baltimore, Maryland
Collaborators
Patient-Centered Outcomes Research Institute, University of Arizona, University of Maryland, University of Miami, Stanford University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations