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

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.

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