Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Drug: Placebo; Drug: Venlafaxine 37.5mg; Drug: Atomoxetine 80mg combined with oxybutynin 5mg; Drug: oxybutynin 5mg combined with trazodone 100mg

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: atomoxetine 80mg combined with oxybutynin 5mg; Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).	Drug: Placebo; Placebo tablet; Drug: Atomoxetine 80mg combined with oxybutynin 5mg; Atomoxetine 80mg combined with oxybutynin 5mg
Experimental: venlafaxine 37.5mg; Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).	Drug: Placebo; Placebo tablet; Drug: Venlafaxine 37.5mg; Venlafaxine 37.5mg
Experimental: oxybutynin 5mg combined with trazodone 100mg; Participants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study).	Drug: Placebo; Placebo tablet; Drug: oxybutynin 5mg combined with trazodone 100mg; oxybutynin 5mg combined with trazodone 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index	Change in apnea-hypopnea index.	Pre-intervention and after single night intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arousal threshold	Endotyping using polysomnography will be estimated with the PUP method.	Pre-intervention and after single night intervention
Upper airway collapsibility	Endotyping using polysomnography will be estimated with the PUP method.	Pre-intervention and after single night intervention
Loop gain	Endotyping using polysomnography will be estimated with the PUP method.	Pre-intervention and after single night intervention
Upper airway muscle compensation	Endotyping using polysomnography will be estimated with the PUP method.	Pre-intervention and after single night intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	sleep archietecture in polysomnography	Pre-intervention and after single night intervention
Waking sleepiness	Karolinska Sleepiness Scale	Pre-intervention and after single night intervention

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 22, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: serotonin; Taiwan; compensation; upper airway; noradrenaline
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipids; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Amines; Alcohols; Phenethylamines; Ethylamines; Propylamines; Piperazines; Cyclohexanols; Hexanols; Fatty Alcohols; Pyridones; Atomoxetine Hydrochloride; Venlafaxine Hydrochloride; Trazodone; oxybutynin
• Other Study ID Numbers: CMUH112-REC3-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No