Evaluation of Atomoxetine and DAW2020 for Treating Moderate-to-Severe Obstructive Sleep Apnea in Adults Aged 21 to 70

What this Trial Is About

Obstructive sleep apnea OSA is a common condition with serious health effects, but treatment options are limited. Researchers are studying the combination of atomoxetine and DAW2020 to reduce OSA severity. Previous studies showed atomoxetine with oxybutynin had some effect but also lowered arousal threshold, which is important in OSA. DAW2020, a hypnotic that prolonged sleep time with fewer side effects, may be a better partner for atomoxetine in this treatment approach. Participants will undergo two overnight sleep studies one with the study drugs and one with placebo, separated by a month-long washout period. Atomoxetine will be taken daily, starting at 40 mg for three days then increasing to 80 mg for four days, with DAW2020 given at 34 mg one hour before sleep for one week. During study nights, participants will breathe naturally without CPAP and be monitored with full sleep studies to assess sleep quality, breathing events, and physiological measures such as arousal and oxygen levels. Participants will visit the lab in the evening for monitoring with polysomnography and physiological assessments. A medical history, physical exam, and pregnancy test for premenopausal women will be done before each nights study. Researchers will measure the effect of the drug combination on OSA severity, arousal index, and oxygen desaturation over one week. The study is randomized and blinded, with careful safety and physiological monitoring throughout the trial.

Atomoxetine and DAW2022 on OSA Severity