Impact of Muscle Training Device on Non-Severe OSA

NCT ID: NCT06910930

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-03-15

Brief Summary

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The goal of this clinical trial is to test for the efficacy of the newly invented device #DidgeriTU with non-severe obstructive sleep apnea. The main question it aims to answer is:

• Can DidgeriTU reduce apnea events in patients with non-severe obstructive sleep apnea? Researchers will compare DidgeriTU with a sham device to see how the apnea event has changed.

Participants will:

* Use DidgeriTU or sham device for 3 month
* Do an online questionnaire once a month during the study
* Home sleep test, lung function test, and tongue strength test at the start and end of the study

Detailed Description

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Previously, in Switzerland, an aboriginal musical instrument, the Didgeridoo, was taught to patients with OSA. It has been proven to be effective in reducing apnea events.

Our newly invented instrument, DidgeriTU, adopts the Didgeridoo principle for expiratory muscle exercise to reduce apnea events.

Conditions

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OSA Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DidgeriTU

patients with non severe OSA using DidgeriTU device

Group Type ACTIVE_COMPARATOR

DidgeriTU

Intervention Type DEVICE

the study device that immitate the principle of didgeridoo for expiratory muscle exercise

sham device

Patients with non severe OSA receive a device that look alike didgeriTU but without resistance plate

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DEVICE

a device that look alike DidgeriTU but without resistance plate

Interventions

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DidgeriTU

the study device that immitate the principle of didgeridoo for expiratory muscle exercise

Intervention Type DEVICE

Sham device

a device that look alike DidgeriTU but without resistance plate

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with mild to moderate obstructive sleep apnea.
* Age 18 years or older.
* Patients voluntarily consent to provide information for research purposes.

Exclusion Criteria

* Patients with an average apnea-hypopnea index (AHI) of \<4 or \>29 events per hour after repeated diagnosis using a home sleep apnea test.
* Patients who refused to cease using CPAP during the study process
* Patients with a history of chronic lung disease.
* Elderly patients with neurological conditions that impair cognitive function, such as dementia, stroke, or psychiatric disorders.
* Patients taking medications that may affect muscle function within 3 months before the start of the study.
* Patients with hypothyroidism or other conditions that may affect muscle function.
* Patients who consume alcohol at a moderate level or higher
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Naphitchaya Wiriya

Naphitchaya Wiriya, MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thammasat University Hospital

Pathum Thani, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Naphitchaya Wiriya, Internal medicine

Role: CONTACT

+66870883390

Facility Contacts

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Naphitchaya Wiriya

Role: primary

66870883390

Other Identifiers

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MTU-EC-IM-0-293/67

Identifier Type: -

Identifier Source: org_study_id

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