Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Sleep apnea treatments, Dental device for sleep, Positive airway pressure, Atomoxetine-oxybutynin, Comparative effectiveness
Brief summary
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.
Interventions
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
DEVICESleep dental 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.
DRUGAtomoxetine-oxybutynin
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Sponsors
Sairam Parthasarathy
Patient-Centered Outcomes Research Institute
University of Arizona
University of Maryland
University of Miami
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized to receive 1 of 3 possible OSA treatments - positive airway pressure (PAP) therapy, dental device, or medication treatment with atomoxetine-oxybutynin.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| OSA treatment effectiveness - Effective AHI score | 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. |
| OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a | 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. |
| Changes in systolic blood pressure | 12 months | 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 | 12 months | To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months. |
| OSA treatment adherence | 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. |
| Adverse effects of OSA treatment | 12 months | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 |
| Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months | 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. |
Countries
United States
Contacts
CONTACTHeidi Erickson, BSN, RN
PRINCIPAL_INVESTIGATORSairam Parthasarathy, MD
University of Arizona
Outcome results
None listed