Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Positive airway pressure (PAP) therapy 		Participants will use a PAP machine to treat their obstructive sleep apnea.
  • Device: Positive airway pressure (PAP) therapy
    Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
    Other names:
    • CPAP
Active Comparator
Dental device 		Participants will use a sleep dental device to treat their obstructive sleep apnea.
  • Device: 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.
    Other names:
    • Mandibular advancement device (MAD)
Active Comparator
Medications - atomoxetine-oxybutynin 		Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
  • Drug: Atomoxetine-oxybutynin
    The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Recruiting Locations

Banner University Medical Center Tucson
Tucson, Arizona 85719
Contact:
Nayeli Lopez
1-520-621-6756
ADAPT-OSAstudy@arizona.edu

More Details

Status
Recruiting
Sponsor
Sairam Parthasarathy

Study Contact

Heidi Erickson, BSN, RN
1-520-626-5287
herickso@arizona.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.