CompletedPhase 4

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Taiwan45 participantsStarted 2024-11-05

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Apnea-hypopnea index

Timeframe: Pre-intervention and after single night intervention

Trial details

NCT IDNCT06295562

SponsorChina Medical University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Obstructive Sleep Apnea of Adult trials