Obstructive Sleep Apnea of AdultPhase 4NCT06295562

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

A Phase 4 study testing Atomoxetine 80mg combined with oxybutynin 5mg, Venlafaxine 37.5mg and oxybutynin 5mg combined with trazodone 100mg in people with Obstructive Sleep Apnea of Adult, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Obstructive Sleep Apnea of Adult
What is being tested?: Atomoxetine 80mg combined with oxybutynin 5mg, Venlafaxine 37.5mg and oxybutynin 5mg combined with trazodone 100mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteTaiwan
Study dates: 5 Nov 2024to 22 Oct 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

apnea-hypopnea index ≥ 15 hr-¹

Who cannot join

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)

Show all 9Show fewer

pregnant or lactating
periodic limb movement index > 15hr-1
the presence of sleep-related hypoventilation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

China Medical University Hospital
Taichung

Other trials in Taiwan

About this study

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.

Conditions: Obstructive Sleep Apnea of Adult
Being tested: Atomoxetine 80mg combined with oxybutynin 5mg, Venlafaxine 37.5mg, oxybutynin 5mg combined with trazodone 100mg, Placebo
Keywords: compensation, upper airway, Taiwan, serotonin, noradrenaline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atomoxetine 80mg combined with oxybutynin 5mgDrug
Atomoxetine 80mg combined with oxybutynin 5mg
Venlafaxine 37.5mgDrug
Venlafaxine 37.5mg
oxybutynin 5mg combined with trazodone 100mgDrug
oxybutynin 5mg combined with trazodone 100mg
PlaceboDrug
Placebo tablet

Study groups in NCT06295562
Study group	Role	What they receive
atomoxetine 80mg combined with oxybutynin 5mg	Experimental	Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study). Receives: Drug: Atomoxetine 80mg combined with oxybutynin 5mg; Drug: Placebo
venlafaxine 37.5mg	Experimental	Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study). Receives: Drug: Venlafaxine 37.5mg; Drug: Placebo
oxybutynin 5mg combined with trazodone 100mg	Experimental	Participants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study). Receives: Drug: oxybutynin 5mg combined with trazodone 100mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnea-hypopnea index
Change in apnea-hypopnea index.
Measured: Pre-intervention and after single night intervention

Secondary outcomes (4)

Arousal threshold
Endotyping using polysomnography will be estimated with the PUP method.
Measured: Pre-intervention and after single night intervention
Upper airway collapsibility
Endotyping using polysomnography will be estimated with the PUP method.
Measured: Pre-intervention and after single night intervention
Loop gain
Endotyping using polysomnography will be estimated with the PUP method.
Measured: Pre-intervention and after single night intervention
Upper airway muscle compensation
Endotyping using polysomnography will be estimated with the PUP method.
Measured: Pre-intervention and after single night intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202422 Oct 2025

First posted6 Mar 2024
Study start5 Nov 2024
Primary completion10 Oct 2025
Study completion22 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
More trials run by China Medical University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06295562
Sponsor's protocol ID: CMUH112-REC3-201
Status last verified: Apr 2026
First submitted: 16 Feb 2024
Last updated: 23 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline

All Obstructive Sleep Apnea of Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT06295562
Acronym / sponsor ID: CMUH112-REC3-201
Conditions: Obstructive Sleep Apnea of Adult
Keywords: compensation, upper airway, Taiwan, serotonin, noradrenaline
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: China Medical University HospitalUniversity, hospital or other
Study start: 5 Nov 2024 (actual)
Primary completion: 10 Oct 2025 (actual)
Study completion: 22 Oct 2025 (actual)
First posted: 6 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
atomoxetine 80mg combined with oxybutynin 5mg	Experimental	Drug: Atomoxetine 80mg combined with oxybutynin 5mg, Drug: PlaceboParticipants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
venlafaxine 37.5mg	Experimental	Drug: Venlafaxine 37.5mg, Drug: PlaceboParticipants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
oxybutynin 5mg combined with trazodone 100mg	Experimental	Drug: oxybutynin 5mg combined with trazodone 100mg, Drug: PlaceboParticipants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study).

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

apnea-hypopnea index ≥ 15 hr-¹

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atomoxetine 80mg combined with oxybutynin 5mgAtomoxetine 80mg combined with oxybutynin 5mg	Drug	atomoxetine 80mg combined with oxybutynin 5mg
Venlafaxine 37.5mgVenlafaxine 37.5mg	Drug	venlafaxine 37.5mg
oxybutynin 5mg combined with trazodone 100mgoxybutynin 5mg combined with trazodone 100mg	Drug	oxybutynin 5mg combined with trazodone 100mg
PlaceboPlacebo tablet	Drug	atomoxetine 80mg combined with oxybutynin 5mg, oxybutynin 5mg combined with trazodone 100mg, venlafaxine 37.5mg

Primary outcome

Apnea-hypopnea index
Time frame: Pre-intervention and after single night intervention
Change in apnea-hypopnea index.

4 secondary outcomes

Arousal threshold
Time frame: Pre-intervention and after single night intervention
Upper airway collapsibility
Time frame: Pre-intervention and after single night intervention
Loop gain
Time frame: Pre-intervention and after single night intervention
Upper airway muscle compensation
Time frame: Pre-intervention and after single night intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea of Adult

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-hypopnea index (time frame: Pre-intervention and after single night intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.