Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-10-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

NCT02908529

Obstructive Sleep Apnea (OSA)

COMPLETED PHASE1/PHASE2

Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy

NCT05550246

Obstructive Sleep Apnea

UNKNOWN PHASE1/PHASE2

Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea

NCT03892772

Sleep Apnea

COMPLETED PHASE1/PHASE2

Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea

NCT05944965

OSA

COMPLETED PHASE1/PHASE2

Pharmacological Intervention for Symptomatic Snoring

NCT03720353

Snoring

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea of Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

atomoxetine 80mg combined with oxybutynin 5mg

Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).

Group Type EXPERIMENTAL

Atomoxetine 80mg combined with oxybutynin 5mg

Intervention Type DRUG

Atomoxetine 80mg combined with oxybutynin 5mg

Placebo

Intervention Type DRUG

Placebo tablet

venlafaxine 37.5mg

Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).

Group Type EXPERIMENTAL

Venlafaxine 37.5mg

Intervention Type DRUG

Venlafaxine 37.5mg

Placebo

Intervention Type DRUG

Placebo tablet

atomoxetine 80mg combined with trazodone 100mg

Participants will receive atomoxetine 80mg combined with trazodone 100mg once (1 h before polysomnographic study).

Group Type EXPERIMENTAL

Atomoxetine 80mg combined with trazodone 100mg

Intervention Type DRUG

Atomoxetine 80mg combined with trazodone 100mg

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atomoxetine 80mg combined with oxybutynin 5mg

Intervention Type DRUG

Venlafaxine 37.5mg

Intervention Type DRUG

Atomoxetine 80mg combined with trazodone 100mg

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No