A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and A… (NCT07679282) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
United States2,400 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.