Clinical trial NCT06910930: Impact of Muscle Training Device on Non-Severe OSA
Official title: Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OSA
Obstructive Sleep Apnea
Keywords: Device
EMST
Powerbreathe
didgeridoo
didgeriTU
Expiratory muscle exercise
reverse CPAP
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of apnea event after DidgeriTU usage compared with sham device
timeFrame: 3 months
Secondary outcomes:
measure: Change of OSA severity after the usage of DidgeriTU comparing with sham device
timeFrame: 3 months
measure: Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device
timeFrame: 3 months
measure: Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device
timeFrame: 3 months
measure: Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device
timeFrame: 3 months
measure: change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device
timeFrame: 3 months
measure: Change of snoring frequency after DidgeriTU usage compared with a sham device
timeFrame: 3 months
measure: change of oxygenation during sleep after DidgeriTU usage comparing with sham device
timeFrame: 3 months
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Thammasat University Hospital
Study officials:
References: