Obstructive Sleep Apnea, OSA
Conditions
Keywords
Device, EMST, Powerbreathe, didgeridoo, didgeriTU, Expiratory muscle exercise, reverse CPAP
Brief 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 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.
Interventions
DEVICEDidgeriTU
the study device that immitate the principle of didgeridoo for expiratory muscle exercise
DEVICESham device
a device that look alike DidgeriTU but without resistance plate
Sponsors
Thammasat University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of apnea event after DidgeriTU usage compared with sham device | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of OSA severity after the usage of DidgeriTU comparing with sham device | 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 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. |
| Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device | 3 months | 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. |
| Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device | 3 months | 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. |
| Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device | 3 months | 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. |
| change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device | 3 months | 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. |
| Change of snoring frequency after DidgeriTU usage compared with a sham device | 3 months | 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. |
| change of oxygenation during sleep after DidgeriTU usage comparing with sham device | 3 months | 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. |
Countries
Thailand
Contacts
CONTACTNaphitchaya Wiriya, Internal medicine
Outcome results
None listed