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

RecruitingPhase 4Ages 18 Years - anyAllSairam Parthasarathy
NCT07679282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Positive airway pressure (PAP) therapy
  • Sleep dental device
  • Atomoxetine-oxybutynin
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Where

4 sites
Banner University Medical Center Tucson
Tucson, United States
Stanford Medical Center
Redwood City, United States
University of Miami Miller School of Medicine
Miami, United States
University of Maryland Baltimore
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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