A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sairam Parthasarathy
Study ID
NCT07679282
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positive airway pressure (PAP) therapy — DEVICE
    Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
  • Sleep dental device — 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 — DRUG
    The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2030
Completion
May 1, 2032

Study Design

Enrollment
2,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Banner University Medical Center TucsonTucsonArizona85719
Nayeli Lopez
[email protected]
1-520-626-6453
Saif Mashaqi, MD (SUB_INVESTIGATOR)
Monisha Das Ireland, MD (SUB_INVESTIGATOR)
Sairam Parthasarathy, MD (PRINCIPAL_INVESTIGATOR)
Stanford Medical CenterPalo AltoCalifornia94305
Clete Kushida, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of MedicineMiamiFlorida33136
Nina L'Houtellier
[email protected]
1-305-689-1358
Girardin Jean-Louis, PhD (PRINCIPAL_INVESTIGATOR)
Alexandre Abreu, MD (SUB_INVESTIGATOR)
University of Maryland Medical CenterBaltimoreMaryland21201
Christine Johnston
[email protected]
1-410-706-7853
Emerson Wickwire, PhD (PRINCIPAL_INVESTIGATOR)
Danielle Glick, MD (SUB_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
Banner University Medical Center Tucson· Tucson, AZStanford Medical Center· Palo Alto, CAUniversity of Miami Miller School of Medicine· Miami, FLUniversity of Maryland Medical Center· Baltimore, MD

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