Recruiting

PAP, Dental Device, Atomoxetine & Oxybutynin

Sponsor:

Sairam Parthasarathy

Code:

NCT07679282

Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positive airway pressure (PAP) therapy

Sleep dental device

Atomoxetine-oxybutynin

Study Details

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT07679282

Start date

Sep 4, 2026

Status verified date

Sep, 2026

Completion date

May 1, 2032

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Positive airway pressure (PAP) therapy

Participants will use a PAP machine to treat their obstructive sleep apnea.

active comparator: Dental device

Participants will use a sleep dental device to treat their obstructive sleep apnea.

active comparator: Medications - atomoxetine-oxybutynin

Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.

Interventions

Positive airway pressure (PAP) therapy

Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.

Sleep 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.

Atomoxetine-oxybutynin

The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Primary outcome measure

  • Health-related quality of life [ Time Frame: At 12 months ]

Central Contacts and Locations

Central contacts

Heidi Erickson, BSN, RN

1-520-626-5287herickso@arizona.edu

Locations

Banner University Medical Center Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Nayeli Lopez

1-520-621-6756ADAPT-OSAstudy@arizona.edu

Principal Investigator:

Sairam Parthasarathy, MD

More Information

Sponsor

Sairam Parthasarathy

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Sleep apnea treatments
  • Dental device for sleep
  • Positive airway pressure
  • Atomoxetine-oxybutynin
  • Comparative effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Sairam Parthasarathy on 2026-09-11.