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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Arizona | OTHER |
| University of Maryland | OTHER |
| University of Miami |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive airway pressure (PAP) therapy | Active Comparator | Participants will use a PAP machine to treat their obstructive sleep apnea. |
|
| Dental device | Active Comparator | Participants will use a sleep dental device to treat their obstructive sleep apnea. |
|
| Medications - atomoxetine-oxybutynin | Active Comparator | Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi Erickson, BSN, RN | Contact | 1-520-626-5287 | herickso@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sairam Parthasarathy, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson | Tucson | Arizona | 85719 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36538809 | Background | 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. | |
| 30395486 |
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De-identified outcomes data, including a data dictionary will be made available.
One year after the primary paper has been accepted and secondary paper has been submitted. Data will be available for as long as Dr. Parthasarathy is with the University of Arizona.
Researchers that contact the primary PI (S. Parthasarathy, MD) with a proposal to use the data and complete a data use agreement with the University of Arizona.
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| OTHER |
| Stanford University | OTHER |
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.
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|
| 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. |
|
| 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. | 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. | 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. | 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. | 12 months |
| Adverse effects of OSA treatment | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | 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. | 12 months |
| Stanford Medical Center | Palo Alto | California | 94305 | United States |
|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
|
| 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. |
| 35551600 | Background | 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. |
| 35975547 | Background | 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. |
| 36184258 | Background | 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. |
| 34131226 | Background | 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. |
| 29129030 | Background | 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. |
| 26094920 | Background | 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. |
| 17699143 | Background | 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. |
| 15781100 | Background | 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. |
| 22983957 | Background | 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. |
| 19544757 | Background | 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. |
| 22043130 | Background | 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. |
| 22131602 | Background | 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. |
| 27571048 | Background | 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. |
| 20339144 | Background | Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25. |
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| 18250205 | Background | Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG. |
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| 18250209 | Background | Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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