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NCT Number: NCT06295562

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine 80mg combined with oxybutynin 5mg

Drug

Atomoxetine 80mg combined with oxybutynin 5mg

Venlafaxine 37.5mg

Drug

Venlafaxine 37.5mg

oxybutynin 5mg combined with trazodone 100mg

Drug

oxybutynin 5mg combined with trazodone 100mg

Placebo

Drug

Placebo tablet

Primary outcomes

  1. Apnea-hypopnea index

    Time frame: Pre-intervention and after single night intervention

    Change in apnea-hypopnea index.

Secondary outcomes

  1. Arousal threshold

    Time frame: Pre-intervention and after single night intervention

    Endotyping using polysomnography will be estimated with the PUP method.

  2. Upper airway collapsibility

    Time frame: Pre-intervention and after single night intervention

    Endotyping using polysomnography will be estimated with the PUP method.

  3. Loop gain

    Time frame: Pre-intervention and after single night intervention

    Endotyping using polysomnography will be estimated with the PUP method.

  4. Upper airway muscle compensation

    Time frame: Pre-intervention and after single night intervention

    Endotyping using polysomnography will be estimated with the PUP method.

Other outcomes

  1. Sleep quality

    Time frame: Pre-intervention and after single night intervention

    sleep archietecture in polysomnography

  2. Waking sleepiness

    Time frame: Pre-intervention and after single night intervention

    Karolinska Sleepiness Scale

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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