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Recruiting NCT06910930

Impact of Muscle Training Device on Non-Severe OSA

No phase Interventional OSA Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DidgeriTU, Sham device.
Who it may be relevant to
Registry conditions: OSA, Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study

Overview

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

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.

Interventions

  • Device DidgeriTU
    the study device that immitate the principle of didgeridoo for expiratory muscle exercise
  • Device Sham device
    a device that look alike DidgeriTU but without resistance plate

Primary outcome measures

  • Change of apnea event after DidgeriTU usage compared with sham device [Time frame: 3 months]
Secondary outcome measures (7)
  • Change of OSA severity after the usage of DidgeriTU comparing with sham device [Time frame: 3 months]
  • Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device [Time frame: 3 months]
  • Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device [Time frame: 3 months]
  • Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device [Time frame: 3 months]
  • change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device [Time frame: 3 months]
  • Change of snoring frequency after DidgeriTU usage compared with a sham device [Time frame: 3 months]
  • change of oxygenation during sleep after DidgeriTU usage comparing with sham device [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Thammasat University Hospital — Pathum Thani

Identifiers

NCT: NCT06910930 · MTU-EC-IM-0-293/67

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗