Impact of Muscle Training Device on Non-Severe OSA

Thammasat University Hospital

Status: Enrolling

Conditions: OSA; Obstructive Sleep Apnea

Treatments: Device: Sham device; Device: DidgeriTU

Study type: Interventional

Funder types: Other

Identifiers

NCT06910930

MTU-EC-IM-0-293/67

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

DidgeriTU

Active Comparator group

Description:

patients with non severe OSA using DidgeriTU device

Treatment:

Device: DidgeriTU

sham device

Sham Comparator group

Description:

Patients with non severe OSA receive a device that look alike didgeriTU but without resistance plate

Treatment:

Device: Sham device