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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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
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- 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.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Christine Johnston, 1-410-706-1486, christine.johnston@som.umaryland.edu
Emerson Wickwire, PhD
- Not yet 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
- 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
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- 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 group | Role | What they receive |
|---|---|---|
| Positive airway pressure (PAP) therapy | Active comparator | Participants will use a PAP machine to treat their obstructive sleep apnea. Receives: Device: Positive airway pressure (PAP) therapy |
| Dental device | Active comparator | Participants will use a sleep dental device to treat their obstructive sleep apnea. Receives: Device: Sleep dental device |
| Medications - atomoxetine-oxybutynin | Active comparator | Participants 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.
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)
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
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
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
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
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
Adverse effects of OSA treatment
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: 12 months
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.
- First posted1 Jul 2026
- Study start4 Sep 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sairam Parthasarathy
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Arizona, University of Maryland, University of Miami, Stanford University
- Responsible party
- Sponsor-investigator, Sairam Parthasarathy, University of Arizona
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, University of Arizona
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 36538809Taranto-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 30395486Schweitzer 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 35551600Rosenberg 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 35975547Kinouchi 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 36184258Chen 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 34131226Schwartz 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 29129030Ramar 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 26094920Chan 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 17699143Marin 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 15781100Martinez-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 22983957Platt 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 19544757Bakker 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 22043130Billings 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 22131602McEvoy 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