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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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The purpose of this study is to explore the effects and safety of transcutaneous electrical nerve stimulation (TENS) at home for patients diagnosed with insomnia on the improvement of insomnia and nervous stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Transcutaneous trigeminal nerve stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day |
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| Control group | Sham Comparator | Sham stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B | Device | A device that improves insomnia symptoms by transcutaneously applying electrical stimulation including a pulse (10 kHz) burst waveform (10 Hz) to the forehead area to the trigeminal nerve |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Insomnia Severity Index (ISI) | Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment: | after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of ISI | Remission rate of ISI after 4 weeks compared to before treatment (Remission: ISI score of 7 or less) | after 4 weeks |
| Response rate of ISI | Response rate of ISI after 4 weeks compared to before treatment (Response: ISI change of more than 7 points or 50% or more decrease) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria prior to intervention (After the sleep diary for one week after the screening test, if the following criteria are met, the patient will be excluded from participation in the study before the intervention.)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiwon Lee, PhD | Contact | +82-535-2871 | clinical.trials@ybrain.com | |
| Jinuk Kim, PhD | Contact | +82-10-5185-4561 | jinuk.kim@ybrain.com |
| Name | Affiliation | Role |
|---|---|---|
| Changho Yoon, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sham Stimulation using YPS-401B | Device | A device that is attached in the same way as a real medical device, but actually applies a shum stimulus |
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| after 4 weeks |
| Changes in Pittsburgh Slepp Quality Index (PSQI) | Changes in Pittsburgh Slepp Quality Index (PSQI) after 4 weeks compared to before treatment | after 4 weeks |
| Changes in index of slepp diary | Changes in index of sleep diary (sleep latency, bedtime, sleep time) after 4 weeks compared to before treatment | after 4 weeks |
| Changes in EEG index | Changes in EEG index (absolute power, relative power) after 4 weeks compared to before treatment | after 4 weeks |
| D001523 |
| Mental Disorders |