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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,400
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Banner University Medical Center Tucson
Tucson, Arizona, United States
RECRUITINGStanford Medical Center
Redwood City, California, United States
NOT_YET_RECRUITINGUniversity of Miami Miller School of Medicine
Miami, Florida, United States
NOT_YET_RECRUITINGUniversity of Maryland Baltimore
Baltimore, Maryland, United States
NOT_YET_RECRUITINGHealth-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.
Time frame: At 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
OSA treatment adherence
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.
Time frame: 12 months
Adverse effects of OSA treatment
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: 12 months
Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 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.
Time frame: 12 months
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