Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

China Medical University

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Drug: Venlafaxine 37.5mg; Drug: Placebo; Drug: Atomoxetine 80mg combined with trazodone 100mg; Drug: Atomoxetine 80mg combined with oxybutynin 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06295562

CMUH112-REC3-201

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

atomoxetine 80mg combined with oxybutynin 5mg

Experimental group

Description:

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

Treatment:

Drug: Atomoxetine 80mg combined with oxybutynin 5mg

Drug: Placebo

venlafaxine 37.5mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Venlafaxine 37.5mg

atomoxetine 80mg combined with trazodone 100mg

Experimental group

Description:

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

Treatment:

Drug: Atomoxetine 80mg combined with trazodone 100mg

Drug: Placebo