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NOT YET RECRUITING
NCT07679282
PHASE4

A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults

Sponsor: Sairam Parthasarathy

View on ClinicalTrials.gov

Summary

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.

Official title: Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2026-09-01

Completion Date

2032-05-01

Last Updated

2026-07-01

Healthy Volunteers

No

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.

Locations (4)

Banner University Medical Center Tucson

Tucson, Arizona, United States

Stanford Medical Center

Palo Alto, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

University of Maryland Medical Center

Baltimore, Maryland, United States