Trial studying safety and effects for Obstructive Sleep Apnea (OSA)
Official title A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
ClinicalTrials.gov ID: NCT07679282
What this study is testing
What is Atomoxetine-oxybutynin?
Atomoxetine-oxybutynin is an investigational medicine, being studied as a potential treatment for obstructive sleep apnea (osa).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out which of the three treatments works best and is easiest for patients to keep using.
- Who it's for
- Adults who have obstructive sleep apnea and meet the study’s eligibility criteria.
- What's involved
- Participants will be randomly assigned to use a CPAP machine, a dental device, or a combo of atomoxetine and oxybutynin, and will complete surveys about side effects and treatment use.
- Time commitment
- The study lasts about one year with two clinic visits and four phone check‑ins.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Redwood City, California, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Redwood City, California, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.