drugset / Trial / NCT06295562

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

NCT06295562

Phase 4 Completed 45 enrolled China Medical University Hospital
RandomizedParallel-groupSingle-blindTreatment

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) oxybutynin 5mg 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.

Timeline

Start
2024-11-05
Primary completion
2025-10-10
Completion
2025-10-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Atomoxetine Other / unclassified 80 mg
Subject Oxybutynin Small molecule 5 mg
Subject Trazodone Small molecule 100 mg
Subject Venlafaxine Small molecule 37.5 mg