NCT06295562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

February 16, 2024

Last Update Submit

April 17, 2026

Conditions

Obstructive Sleep Apnea of Adult

Keywords

compensationupper airwayTaiwanserotoninnoradrenaline

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index

    Change in apnea-hypopnea index.

    Pre-intervention and after single night intervention

Secondary Outcomes (4)

  • Arousal threshold

    Pre-intervention and after single night intervention

  • Upper airway collapsibility

    Pre-intervention and after single night intervention

  • Loop gain

    Pre-intervention and after single night intervention

  • Upper airway muscle compensation

    Pre-intervention and after single night intervention

Other Outcomes (2)

  • Sleep quality

    Pre-intervention and after single night intervention

  • Waking sleepiness

    Pre-intervention and after single night intervention

Study Arms (3)

atomoxetine 80mg combined with oxybutynin 5mg

EXPERIMENTAL

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

Drug: Atomoxetine 80mg combined with oxybutynin 5mgDrug: Placebo

venlafaxine 37.5mg

EXPERIMENTAL

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

Drug: Venlafaxine 37.5mgDrug: Placebo

oxybutynin 5mg combined with trazodone 100mg

EXPERIMENTAL

Participants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study).

Drug: oxybutynin 5mg combined with trazodone 100mgDrug: Placebo

Interventions

Atomoxetine 80mg combined with oxybutynin 5mgDRUG

Atomoxetine 80mg combined with oxybutynin 5mg

atomoxetine 80mg combined with oxybutynin 5mg
Venlafaxine 37.5mgDRUG

Venlafaxine 37.5mg

venlafaxine 37.5mg
oxybutynin 5mg combined with trazodone 100mgDRUG

oxybutynin 5mg combined with trazodone 100mg

oxybutynin 5mg combined with trazodone 100mg
PlaceboDRUG

Placebo tablet

atomoxetine 80mg combined with oxybutynin 5mgoxybutynin 5mg combined with trazodone 100mgvenlafaxine 37.5mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apnea-hypopnea index ≥ 15 hr-¹

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Interventions

Atomoxetine HydrochlorideoxybutyninVenlafaxine HydrochlorideTrazodone

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipidsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 6, 2024

Study Start

November 5, 2024

Primary Completion

October 10, 2025

Study Completion

October 22, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)