NCT06295562

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DRUG	Atomoxetine 80mg combined with oxybutynin 5mg	Atomoxetine 80mg combined with oxybutynin 5mg
DRUG	Venlafaxine 37.5mg	Venlafaxine 37.5mg
DRUG	Atomoxetine 80mg combined with trazodone 100mg	Atomoxetine 80mg combined with trazodone 100mg
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2024-11-05
• Primary completion: 2025-10-10
• Completion: 2025-10-22
• First posted: 2024-03-06
• Last updated: 2025-12-02

Locations

1 site across 1 country: Taiwan