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NCT Number: NCT07679282

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

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Banner University Medical Center Tucson, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive airway pressure (PAP) therapy

Device

Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.

Other names: CPAP

Sleep dental device

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)

Atomoxetine-oxybutynin

Drug

The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adverse effects of OSA treatment

    Time frame: 12 months

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Erickson, BSN, RN

CONTACT

[email protected]

1-520-626-5287

Sponsors and collaborators

Lead sponsor

Sairam Parthasarathy

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ADAPT-OSA

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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