OSANCT06910930
Impact of Muscle Training Device on Non-Severe OSA
A study testing DidgeriTU in people with OSA and Obstructive Sleep Apnea, run by Thammasat University Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA, Obstructive Sleep Apnea
- What is being tested?
- DidgeriTU
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild to moderate obstructive sleep apnea.
- Age 18 years or older.
- Patients voluntarily consent to provide information for research purposes.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University Hospital
Pathum Thani
Naphitchaya Wiriya, 66870883390, Jazhana@gmail.com
About this study
Official title: Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study
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
Read the 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.
- Conditions
- OSA, Obstructive Sleep Apnea
- Being tested
- DidgeriTU, Sham device
- Keywords
- Device, EMST, Powerbreathe, didgeridoo, didgeriTU, Expiratory muscle exercise, reverse CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DidgeriTUDevice
the study device that immitate the principle of didgeridoo for expiratory muscle exercise
Sham deviceDevice
a device that look alike DidgeriTU but without resistance plate
| Study group | Role | What they receive |
|---|---|---|
| DidgeriTU | Active comparator | patients with non severe OSA using DidgeriTU device Receives: Device: DidgeriTU |
| sham device | Sham comparator | Patients with non severe OSA receive a device that look alike didgeriTU but without resistance plate Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of apnea event after DidgeriTU usage compared with sham device
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.
Measured: 3 months
Secondary outcomes (7)
Change of OSA severity after the usage of DidgeriTU comparing with sham device
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.
Measured: 3 months
Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device
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.
Measured: 3 months
Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device
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.
Measured: 3 months
Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device
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.
Measured: 3 months
change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device
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.
Measured: 3 months
Change of snoring frequency after DidgeriTU usage compared with a sham device
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.
Measured: 3 months
change of oxygenation during sleep after DidgeriTU usage comparing with sham device
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 May 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naphitchaya Wiriya, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910930
- Sponsor's protocol ID
- MTU-EC-IM-0-293/67
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06910930
- Acronym / sponsor ID
- MTU-EC-IM-0-293/67
- Conditions
- OSA, Obstructive Sleep Apnea
- Keywords
- Device, EMST, Powerbreathe, didgeridoo, didgeriTU, Expiratory muscle exercise, reverse CPAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DidgeriTU | Active comparator | Device: DidgeriTUpatients with non severe OSA using DidgeriTU device |
| sham device | Sham comparator | Device: Sham devicePatients with non severe OSA receive a device that look alike didgeriTU but without resistance plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with mild to moderate obstructive sleep apnea.
- Age 18 years or older.
- Patients voluntarily consent to provide information for research purposes.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DidgeriTUthe study device that immitate the principle of didgeridoo for expiratory muscle exercise | Device | DidgeriTU |
| Sham devicea device that look alike DidgeriTU but without resistance plate | Device | sham device |
Primary outcome
Change of apnea event after DidgeriTU usage compared with sham device
Time frame: 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.
7 secondary outcomes
Change of OSA severity after the usage of DidgeriTU comparing with sham device
Time frame: 3 months
Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device
Time frame: 3 months
Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device
Time frame: 3 months
Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device
Time frame: 3 months
change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device
Time frame: 3 months
Change of snoring frequency after DidgeriTU usage compared with a sham device
Time frame: 3 months
change of oxygenation during sleep after DidgeriTU usage comparing with sham device
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for OSA
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DidgeriTU in people with OSA and Obstructive Sleep Apnea, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naphitchaya Wiriya, Internal medicine (+66870883390, jazhana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of apnea event after DidgeriTU usage compared with sham device (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.