Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2020-10-27
2021-05-28
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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AD109
Oral capsule administered before sleep
AD109
Oral administration before bed
Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Atomoxetine
Oral capsule administered before sleep
Atomoxetine
Oral administration before bed
Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
R-oxybutynin
Oral capsule administered before sleep
R-oxybutynin
Oral administration before bed
Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Placebo
Oral capsule administered before sleep
Placebo
Oral administration before bed
Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Interventions
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AD109
Oral administration before bed
Atomoxetine
Oral administration before bed
R-oxybutynin
Oral administration before bed
Placebo
Oral administration before bed
Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AHI 10 to \<20, or AHI ≥20 if meets other PSG criteria
Exclusion Criteria
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
25 Years
65 Years
ALL
No
Sponsors
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Apnimed
INDUSTRY
Responsible Party
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Locations
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Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Empire Clinical Research
Pomona, California, United States
Yale University
New Haven, Connecticut, United States
Teradan Clinical Trials
Brandon, Florida, United States
Clinical Trials of Florida
Miami, Florida, United States
The Neurological Center of North Georgia
Gainesville, Georgia, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APC-003
Identifier Type: -
Identifier Source: org_study_id
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