This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.
The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Oral administration before bed
Oral administration before bed
Oral administration before bed
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
Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/hour\]. Events with 4% or greater desaturations were included in the calculation of HB.
Time frame: 1 night (treatment duration) (0-8 hours collected continuously)
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Oral administration before bed
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.
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