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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DidgeriTU | Active Comparator | patients with non severe OSA using DidgeriTU device |
|
| sham device | Sham Comparator | Patients with non severe OSA receive a device that look alike didgeriTU but without resistance plate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DidgeriTU | Device | the study device that immitate the principle of didgeridoo for expiratory muscle exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naphitchaya Wiriya, Internal medicine | Contact | +66870883390 | jazhana@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Recruiting | Pathum Thani | Thailand |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Sham device | Device | a device that look alike DidgeriTU but without resistance plate |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 3 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |