Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Phase 4

Recruiting

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Drug: Atomoxetine 80mg combined with oxybutynin 5mg; Drug: Venlafaxine 37.5mg; Drug: Atomoxetine 80mg combined with trazodone 100mg; Drug: Placebo

• Registration Number: NCT06295562
• Lead Sponsor: China Medical University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Study Start: 2024-11-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• apnea-hypopnea index ≥ 15 hr-¹

Exclusion Criteria

• the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases
• current use of continuous positive airway pressure therapy
• use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study
• known allergy to the investigational medication
• current smoking
• heavy alcohol drinking (male > 14 drinks and women >7 drinks per week)
• pregnant or lactating
• periodic limb movement index ≤ 15hr-1
• the presence of sleep-related hypoventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atomoxetine 80mg combined with oxybutynin 5mg	Atomoxetine 80mg combined with oxybutynin 5mg	Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
atomoxetine 80mg combined with oxybutynin 5mg	Placebo	Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
venlafaxine 37.5mg	Venlafaxine 37.5mg	Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
venlafaxine 37.5mg	Placebo	Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
atomoxetine 80mg combined with trazodone 100mg	Atomoxetine 80mg combined with trazodone 100mg	Participants will receive atomoxetine 80mg combined with trazodone 100mg once (1 h before polysomnographic study).
atomoxetine 80mg combined with trazodone 100mg	Placebo	Participants will receive atomoxetine 80mg combined with trazodone 100mg once (1 h before polysomnographic study).

Primary Outcome Measures

Name	Time	Method
Physiological parameter	Baseline and one week	Change in apnea-hypopnea index.

Secondary Outcome Measures

Name	Time	Method
Endotypic traits	Baseline and one week	Four endotypic traits, namely arousal threshold, upper airway collapsibility, loop gain, and upper airway muscle compensation, will be estimated using the Phenotyping Using Polysomnography method, specifically, a validated cloud-based Python application (PUPpy).

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan