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NCT Number: NCT06910930

Impact of Muscle Training Device on Non-Severe OSA

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

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Key information

Conditions

OSA Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thammasat University Hospital

Pathum Thani, Thailand

Location status: Recruiting

Location contact

Naphitchaya Wiriya

CONTACT

[email protected]

66870883390

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DidgeriTU

Device

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

Sham device

Device

a device that look alike DidgeriTU but without resistance plate

Primary outcomes

  1. Change of apnea event after DidgeriTU usage compared with sham device

    Time frame: 3 months

    Participants with a known history of non-severe obstructive sleep apnea will repeat the home sleep apnea test. The study will include patients with non-severe OSA(Apnea-hypopnea index 5-29/hr) from HSAT. After the usage of DidgeriTU or sham device for 3 months, the participant will repeat HSAT to explore the change of AHI after DidgeriTU use compared with sham device.

Secondary outcomes

  1. Change of OSA severity after the usage of DidgeriTU comparing with sham device

    Time frame: 3 months

    Participants with a known history of non-severe obstructive sleep apnea will repeat the home sleep apnea test. The study will include patients with non-severe OSA(Apnea-hypopnea index 5-29/hr.) from HSAT and categorize patients with AHI 5-14/hr as mild OSA, AHI 15-29/hr as moderate OSA. After the usage of DidgeriTU or sham device for 3 months, the participant will repeat HSAT to explore the change of OSA severity after DidgeriTU use compared with sham device.

  2. Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device

    Time frame: 3 months

    The participants' daytime sleepiness will be evaluated at the beginning of the study by the Thai version of the Epworth sleepiness scale then followed up with an online questionnaire every month until the end of the study. The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. The change in ESS in patients using DidgeriTU will be compared with patients using sham devices.

  3. Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device

    Time frame: 3 months

    The participants' maximum inspiratory pressure; MIP will be measured at the beginning and end of the study to compare the effect of DidgeriTU and sham device with inspiratory muscle which will be reported in cmH2O.

  4. Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device

    Time frame: 3 months

    The participants' maximum expiratory mouth pressure; MEP will be measured at the beginning and end of the study to compare the effect of DidgeriTU and sham device with expiratory muscle which will be reported in cmH2O.

  5. change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device

    Time frame: 3 months

    The participants' sleep quality will be evaluated at the beginning of the study by the Thai version of the Pittsburg sleep quality index then followed up with an online questionnaire every month until the end of the study. The global PSQI score ranges from 0 to 21, where lower scores indicate better sleep quality. The change in PSQI in patients using DidgeriTU will be compared with patients using sham devices.

  6. Change of snoring frequency after DidgeriTU usage compared with a sham device

    Time frame: 3 months

    The snoring index (events/hour) will be recorded from HSAT at the beginning and end of the study. The change of snoring index from patients using DidgeriTU and sham device will be compared.

  7. change of oxygenation during sleep after DidgeriTU usage comparing with sham device

    Time frame: 3 months

    The average oxygen saturation (%) will be recorded from HSAT at the beginning and end of the study. The change in average oxygen saturation from patients using DidgeriTU and sham device will be compared.

Study contacts

Contact information is provided by the study sponsor or research team.

Naphitchaya Wiriya, Internal medicine

CONTACT

[email protected]

+66870883390

Sponsors and collaborators

Lead sponsor

Thammasat University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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