Health TrialsbyHealthPanel

Impact of Muscle Training Device on Non-Severe OSA

ConditionsOSAObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThammasat University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with mild to moderate obstructive sleep apnea.

Age 18 years or older.

Patients voluntarily consent to provide information for research purposes.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DidgeriTU

    Device

    the study device that immitate the principle of didgeridoo for expiratory muscle exercise

  • Sham device

    Device

    a device that look alike DidgeriTU but without resistance plate

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: DidgeriTUActive comparator 1 intervention
Group B: sham deviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thammasat University Hospital

Lead sponsor

Thammasat University

Sponsor institution

Source ClinicalTrials.gov
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