Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) atomoxetine 80mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• apnea-hypopnea index ≥ 15 hr-¹
Locations
Other Locations
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Cheng, Ph.D.
s871065@gmail.com
+886422052121
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 132
Treatments
Experimental: atomoxetine 80mg combined with oxybutynin 5mg
Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
Experimental: venlafaxine 37.5mg
Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
Experimental: atomoxetine 80mg combined with trazodone 100mg
Participants will receive atomoxetine 80mg combined with trazodone 100mg once (1 h before polysomnographic study).
Related Therapeutic Areas
Sponsors
Leads: China Medical University Hospital