Using a new device to reduce apnea events in patients with non-severe obstructive sleep apnea
Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study
This study is testing a new device called DidgeriTU to see if it can help people with non-severe obstructive sleep apnea have fewer breathing pauses during sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thammasat University Hospital Academic / other |
| Locations | 1 site (Pathum Thani) |
| Trial ID | NCT06910930 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of a newly developed device called DidgeriTU, designed to reduce apnea events in patients with non-severe obstructive sleep apnea (OSA). Participants will use either the DidgeriTU or a sham device for three months, during which they will complete monthly online questionnaires and undergo various tests, including home sleep tests and lung function assessments. The study aims to determine if the DidgeriTU can effectively decrease the frequency of apnea events compared to the sham device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with mild to moderate obstructive sleep apnea.
Not a fit: Patients with severe obstructive sleep apnea or those with conditions affecting muscle function may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a non-invasive treatment option for patients with non-severe obstructive sleep apnea.
How similar studies have performed: Previous studies using similar approaches, such as the use of the Didgeridoo for OSA, have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pathum Thani
- Thammasat University Hospital — Pathum Thani, Thailand (Recruiting)
Study contacts
- Study coordinator: Naphitchaya Wiriya, Internal medicine
- Email: jazhana@gmail.com
- Phone: +66870883390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.