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

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.

Conditions

• Obstructive Sleep Apnea (OSA)

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.

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Sairam Parthasarathy

  lead OTHER

Principal Investigators

• Sairam Parthasarathy, MD · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2030-03-01

Completion

2032-05-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations