Effect of Atomoxetine and DAW2022 on OSA Severity
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:
• Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Ludovico Messineo, MD, PhD
lmessineo@bwh.harvard.edu
18572726188
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 18
Treatments
Placebo_comparator: Placebo oral capsules
Placebo (2 pills) before sleep for a week
Active_comparator: Atomoxetine and DAW2020 oral capsules
DAW2020 34 mg 4 h before sleep, single night administration for a week. Simultaneous administration of atomoxetine 40 mg for 3 days 30 min before sleep, 80 mg for the following 4 days, 30 min before sleep
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital