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Obstructive Sleep Apnea (OSA)Phase 4ADAPT-OSANCT07679282

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

A Phase 4 study testing Positive airway pressure (PAP) therapy, Sleep dental device and Atomoxetine-oxybutynin in people with Obstructive Sleep Apnea (OSA), run by Sairam Parthasarathy at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
Positive airway pressure (PAP) therapy, Sleep dental device and Atomoxetine-oxybutynin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
4 sitesUnited States
Study dates
4 Sep 2026to 1 May 2032
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Heidi Erickson, BSN, RN contact

1-520-626-5287

herickso@arizona.edu

United States4 sites, 4 recruiting

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

    Christine Johnston, 1-410-706-1486, christine.johnston@som.umaryland.edu

    Emerson Wickwire, PhD

    Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

    Nina L'Houtellier, 1-305-689-1358, nvl15@med.miami.edu

    Girardin Jean-Louis, PhD

    Not yet recruiting

  • Stanford Medical Center

    Redwood City, California, 94305

    Clete Kushida, MD, PhD, 650-721-7560, clete@stanford.edu

    Clete Kushida, MD, PhD

    Recruiting

  • Banner University Medical Center Tucson

    Tucson, Arizona, 85719

    Nayeli Lopez, 1-520-621-6756, ADAPT-OSAstudy@arizona.edu

    Saif Mashaqi, MD

    Recruiting

Other trials in United States

About this study

Official title: Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

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.

Being tested
Positive airway pressure (PAP) therapy, Sleep dental device, Atomoxetine-oxybutynin
Keywords
Sleep apnea treatments, Dental device for sleep, Positive airway pressure, Atomoxetine-oxybutynin, Comparative effectiveness
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive airway pressure (PAP) therapyDevice

    Also called CPAP

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

  • Sleep dental deviceDevice

    Also called Mandibular advancement device (MAD)

    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-oxybutyninDrug

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

Study groups in NCT07679282
Study groupRoleWhat they receive
Positive airway pressure (PAP) therapyActive comparatorParticipants will use a PAP machine to treat their obstructive sleep apnea.
Receives: Device: Positive airway pressure (PAP) therapy
Dental deviceActive comparatorParticipants will use a sleep dental device to treat their obstructive sleep apnea.
Receives: Device: Sleep dental device
Medications - atomoxetine-oxybutyninActive comparatorParticipants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
Receives: Drug: Atomoxetine-oxybutynin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    To compare the effectiveness of positive airway pressure (PAP) therapy versus dental device versus atomoxetine-oxybutynin for key patient centered outcomes in improving health-related quality of life over 12 months, as assessed by the PROMIS-29 v2.0.

    Measured: At 12 months

Secondary outcomes (7)

  1. OSA treatment effectiveness - Effective AHI score

    To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed by the effective apnea hypopnea index (AHI). Effective AHI equals the sum of apneas and hypopneas with treatment and without treatment divided by hours of total sleep time.

    Measured: 12 months

  2. OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a

    To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed via the PROMIS-Sleep Related Impairment 8a.

    Measured: 12 months

  3. Changes in systolic blood pressure

    To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.

    Measured: 12 months

  4. Changes in diastolic blood pressure

    To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.

    Measured: 12 months

  5. OSA treatment adherence

    To compare treatment adherence (defined as % of nights assigned treatment was used for 4 or more hours) between PAP therapy versus dental device versus atomoxetine-oxybutynin.

    Measured: 12 months

  6. Adverse effects of OSA treatment

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Measured: 12 months

  7. Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months

    Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v2.0 scale. The outcome measure is change in PROMIS Sleep Disturbance T-score from baseline to 12 months. PROMIS Sleep Disturbance scores are standardized T-scores referenced to the U.S. general population (mean=50; SD=10) and range from ~ 20 to 80, with higher scores indicating greater sleep disturbance and worse sleep-related symptoms. Negative values for change from baseline indicate improvement in sleep disturbance. Predictors of treatment response will be evaluated using multivariable logistic regression. The dependent variable will be achievement of a clinically meaningful improvement in PROMIS Sleep Disturbance T-score (MCID responder status). Determinants include treatment assignment, age, sex, race/ethnicity, socioeconomic status, insurance status, baseline sleep apnea severity, obesity, \& other prespecified determinants.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study start4 Sep 2026
  3. Primary completion1 Mar 2030 (estimated)
  4. Study completion1 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07679282
Sponsor's protocol ID
BPS-2024C2-37819
Acronym
ADAPT-OSA
Status last verified
Oct 2026
First submitted
4 Jun 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified outcomes data, including a data dictionary will be made available.

Publications

  • Aishah A, Loffler KA, Toson B, Mukherjee S, Adams RJ, Altree TJ, Ainge-Allen HW, Yee BJ, Grunstein RR, Carberry JC, Eckert DJ. One Month Dosing of Atomoxetine plus Oxybutynin in Obstructive Sleep Apnea: A Randomized, Placebo-controlled Trial. Ann Am Thorac Soc. 2023 Apr;20(4):584-595. doi: 10.1513/AnnalsATS.202206-492OC.

    PubMed 36538809

  • Taranto-Montemurro L, Messineo L, Sands SA, Azarbarzin A, Marques M, Edwards BA, Eckert DJ, White DP, Wellman A. The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276. doi: 10.1164/rccm.201808-1493OC.

    PubMed 30395486

  • Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13.

    PubMed 35551600

  • Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.

    PubMed 35975547

  • Kinouchi T, Terada J, Sakao S, Koshikawa K, Sasaki T, Sugiyama A, Sato S, Sakuma N, Abe M, Shikano K, Hayama N, Shiko Y, Ozawa Y, Ikeda S, Suzuki T, Tatsumi K. Effects of the combination of atomoxetine and oxybutynin in Japanese patients with obstructive sleep apnoea: A randomized controlled crossover trial. Respirology. 2023 Mar;28(3):273-280. doi: 10.1111/resp.14383. Epub 2022 Oct 2.

    PubMed 36184258

  • Chen TY, Chung CH, Chang HA, Kao YC, Chang SY, Kuo TBJ, Yang CCH, Chien WC, Tzeng NS. Long-term atomoxetine-oxybutynin combination use may be beneficial for the prevention of obstructive sleep apnea. Sci Rep. 2021 Jun 15;11(1):12526. doi: 10.1038/s41598-021-91988-5.

    PubMed 34131226

  • Schwartz M, Acosta L, Hung YL, Padilla M, Enciso R. Effects of CPAP and mandibular advancement device treatment in obstructive sleep apnea patients: a systematic review and meta-analysis. Sleep Breath. 2018 Sep;22(3):555-568. doi: 10.1007/s11325-017-1590-6. Epub 2017 Nov 11.

    PubMed 29129030

  • Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.

    PubMed 26094920

  • Chan AS, Lee RW, Cistulli PA. Dental appliance treatment for obstructive sleep apnea. Chest. 2007 Aug;132(2):693-9. doi: 10.1378/chest.06-2038.

    PubMed 17699143

  • Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

    PubMed 15781100

  • Martinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13.

    PubMed 22983957

  • Platt AB, Field SH, Asch DA, Chen Z, Patel NP, Gupta R, Roche DF, Gurubhagavatula I, Christie JD, Kuna ST. Neighborhood of residence is associated with daily adherence to CPAP therapy. Sleep. 2009 Jun;32(6):799-806. doi: 10.1093/sleep/32.6.799.

    PubMed 19544757

  • Bakker JP, O'Keeffe KM, Neill AM, Campbell AJ. Ethnic disparities in CPAP adherence in New Zealand: effects of socioeconomic status, health literacy and self-efficacy. Sleep. 2011 Nov 1;34(11):1595-603. doi: 10.5665/sleep.1404.

    PubMed 22043130

  • Billings ME, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Redline S, Rosen CL, Zee P, Kapur VK. Race and residential socioeconomics as predictors of CPAP adherence. Sleep. 2011 Dec 1;34(12):1653-8. doi: 10.5665/sleep.1428.

    PubMed 22131602

  • McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

    PubMed 27571048

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Positive airway pressure (PAP) therapy, Sleep dental device and Atomoxetine-oxybutynin in people with Obstructive Sleep Apnea (OSA), run by Sairam Parthasarathy at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heidi Erickson, BSN, RN (1-520-626-5287, herickso@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07679282, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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