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)

June 29, 2026 updated by: Sairam Parthasarathy

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center Tucson
        • Principal Investigator:
          • Sairam Parthasarathy, MD
        • Contact:
        • Sub-Investigator:
          • Saif Mashaqi, MD
        • Sub-Investigator:
          • Monisha Das Ireland, MD
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Medical Center
        • Principal Investigator:
          • Clete Kushida, MD, PhD
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
        • Sub-Investigator:
          • Alexandre Abreu, MD
        • Contact:
        • Principal Investigator:
          • Girardin Jean-Louis, PhD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
        • Contact:
        • Principal Investigator:
          • Emerson Wickwire, PhD
        • Sub-Investigator:
          • Danielle Glick, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Positive airway pressure (PAP) therapy
Participants will use a PAP machine to treat their obstructive sleep apnea.
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.
Other Names:
  • CPAP
Active Comparator: Dental device
Participants will use a sleep dental device to treat their obstructive sleep apnea.
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.
Other Names:
  • Mandibular advancement device (MAD)
Active Comparator: Medications - atomoxetine-oxybutynin
Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
Drug: Atomoxetine-oxybutynin
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSA treatment effectiveness - Effective AHI score
Time Frame: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed by the effective apnea hypopnea index (AHI). Effective AHI equals the sum of apneas and hypopneas with treatment and without treatment divided by hours of total sleep time.
12 months
OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a
Time Frame: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed via the PROMIS-Sleep Related Impairment 8a.
12 months
Changes in systolic blood pressure
Time Frame: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.
12 months
Changes in diastolic blood pressure
Time Frame: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.
12 months
OSA treatment adherence
Time Frame: 12 months
To compare treatment adherence (defined as % of nights assigned treatment was used for 4 or more hours) between PAP therapy versus dental device versus atomoxetine-oxybutynin.
12 months
Adverse effects of OSA treatment
Time Frame: 12 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
12 months
Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months
Time Frame: 12 months
Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v2.0 scale. The outcome measure is change in PROMIS Sleep Disturbance T-score from baseline to 12 months. PROMIS Sleep Disturbance scores are standardized T-scores referenced to the U.S. general population (mean=50; SD=10) and range from ~ 20 to 80, with higher scores indicating greater sleep disturbance and worse sleep-related symptoms. Negative values for change from baseline indicate improvement in sleep disturbance. Predictors of treatment response will be evaluated using multivariable logistic regression. The dependent variable will be achievement of a clinically meaningful improvement in PROMIS Sleep Disturbance T-score (MCID responder status). Determinants include treatment assignment, age, sex, race/ethnicity, socioeconomic status, insurance status, baseline sleep apnea severity, obesity, & other prespecified determinants.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sairam Parthasarathy

Collaborators

Patient-Centered Outcomes Research Institute
University of Miami
University of Maryland
Stanford University
University of Arizona

Investigators

  • Principal Investigator: Sairam Parthasarathy, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPS-2024C2-37819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified outcomes data, including a data dictionary will be made available.

IPD Sharing Time Frame

One year after the primary paper has been accepted and secondary paper has been submitted. Data will be available for as long as Dr. Parthasarathy is with the University of Arizona.

IPD Sharing Access Criteria

Researchers that contact the primary PI (S. Parthasarathy, MD) with a proposal to use the data and complete a data use agreement with the University of Arizona.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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