Impact of Muscle Training Device on Non-Severe OSA

Last updated: April 4, 2025
Sponsor: Thammasat University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

DidgeriTU

Sham device

Clinical Study ID

NCT06910930
MTU-EC-IM-0-293/67
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with an average apnea-hypopnea index (AHI) of <4 or >29 events per hourafter 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, suchas dementia, stroke, or psychiatric disorders.

  • Patients taking medications that may affect muscle function within 3 months beforethe 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

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: DidgeriTU
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Thammasat University Hospital

    Pathum Thani,
    Thailand

    Active - Recruiting

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