Impact of Muscle Training Device on Non-Severe OSA

Not Applicable

Recruiting

• Conditions: OSA; Obstructive Sleep Apnea

• Registration Number: NCT06910930
• Lead Sponsor: Thammasat University Hospital

Brief 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

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.

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of apnea event after DidgeriTU usage compared with sham device	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 Outcome Measures

Name	Time	Method
Change of OSA severity after the usage of DidgeriTU comparing with sham device	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.
Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device	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.
Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device	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.
Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device	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.
change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device	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.
Change of snoring frequency after DidgeriTU usage compared with a sham device	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.
change of oxygenation during sleep after DidgeriTU usage comparing with sham device	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.

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Pathum Thani, Thailand