Actively Recruiting
Impact of Muscle Training Device on Non-Severe Obstructive Sleep Apnea: A Randomized Controlled Study
Led by Thammasat University Hospital · Updated on 2026-01-21
76
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a new device called DidgeriTU for people with non-severe obstructive sleep apnea (OSA). This study aims to find out if DidgeriTU can reduce apnea events compared to a similar sham device without the resistance plate. The rationale comes from previous findings where playing the Didgeridoo, an Aboriginal musical instrument, helped reduce apnea events by exercising expiratory muscles. Participants will be randomly assigned to use either the DidgeriTU device or the sham device for three months. DidgeriTU is designed to exercise expiratory muscles based on the Didgeridoo principle. The sham device looks similar but lacks the resistance plate. The study includes a double-blind design, meaning neither participants nor researchers know who gets which device during the trial. During the study, participants will complete an online questionnaire once a month. They will have home sleep tests, lung function tests, and tongue strength tests at the beginning and end of the three-month period. The main outcome measured is the change in apnea events after using the device. Additional assessments include changes in sleep apnea severity, sleepiness levels, inspiratory and expiratory pressures, sleep quality, snoring frequency, and oxygenation during sleep. The study is sponsored by Thammasat University Hospital and lasts for three months per participant.
CONDITIONS
Brief Title
Impact of Muscle Training Device on Non-Severe OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with mild to moderate obstructive sleep apnea
- Age 18 years or older
- Patients voluntarily consent to provide information for research purposes
You will not qualify if you...
- Patients with an average apnea-hypopnea index (AHI) less than 4 or greater than 29 events per hour after repeated diagnosis using a home sleep apnea test
- Patients who refuse to stop using CPAP during the study
- Patients with a history of chronic lung disease
- Elderly patients with neurological conditions impairing cognitive function, such as dementia, stroke, or psychiatric disorders
- Patients taking medications affecting muscle function within 3 months before the study
- Patients with hypothyroidism or other conditions affecting muscle function
- Patients who consume alcohol at a moderate level or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants use the DidgeriTU device or a sham device for expiratory muscle exercise to reduce apnea events.
Regular visits during the 3 months of device usage
Trial Site Locations
Total: 1 location
1
Thammasat University Hospital
Pathum Thani, Thailand
Actively Recruiting
Research Team
N
Naphitchaya Wiriya, Internal medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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