This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.
The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Oral administration before bed
Oral administration before bed
Oral administration before bed
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, United States
Apnea-Hypopnea Index
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
Time frame: 1 day
Hypoxic Burden
Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep
Time frame: 1 day
ODI
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo
Time frame: 1 day
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CTI Clinical Research Center
Cincinnati, Ohio, United States