Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
13 participants
INTERVENTIONAL
2017-09-15
2020-01-20
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 before sleep
Placebo oral capsule
Placebo capsule 30 minutes before sleep
DAW1033B2 oral capsule
DAW1033B2 before sleep
DAW1033B2 oral capsule
DAW1033B2 capsule 30 minutes before sleep
Interventions
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Placebo oral capsule
Placebo capsule 30 minutes before sleep
DAW1033B2 oral capsule
DAW1033B2 capsule 30 minutes before sleep
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, DAW1033D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, 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
Associate professor HMS
Locations
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Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014p001033B2
Identifier Type: -
Identifier Source: org_study_id
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