Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2016-09-30
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo 2 hours before bedtime
Placebo, 2 tablets
Placebo 2 tablets 2 hours before sleep
Combination product of Atomoxetine and Oxybutynin
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
Combination product of Atomoxetine and Oxybutynin
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
Interventions
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Combination product of Atomoxetine and Oxybutynin
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
Placebo, 2 tablets
Placebo 2 tablets 2 hours before sleep
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, atomoxetine/oxybutynin.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as atomoxetine, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
21 Years
65 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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David Andrew Wellman
Assistant Professor of Medicine - Harvard Medical School
Locations
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Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BWH-2014P001033
Identifier Type: -
Identifier Source: org_study_id
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