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.
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
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%
Parallel
Positive airway pressure (PAP) therapy
DevicePositive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
Sleep dental device
DeviceAn oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
Atomoxetine-oxybutynin
DrugThe combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Health-related quality of life
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.
OSA treatment effectiveness - Effective AHI score
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.
OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a
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.
Changes in systolic blood pressure
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.
Changes in diastolic blood pressure
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.
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Sairam Parthasarathy
Lead sponsor
University of Arizona
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
University of Arizona
Collaborator
University of Maryland
Collaborator
University of Miami
Collaborator
Stanford University
Collaborator
