The Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Explore the Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B
* Device: Sham Stimulation using YPS-401B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 19 and under 65 Those who meet the criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for Insomnia Those with a score of 8 or higher based on the Korean version Insomnia severity index (ISI-K) A person whose sleeping environment and habits are regular, usually between 9:00 p.m. and 1:00 a.m., go to bed, lie down for 7 to 10 hours, and wake up between 5 and 10 a.m. In the case of patients who regularly take drugs for improving insomnia at least once a week, those who agree to discontinue taking the prohibited drugs in this study for a total of 5 weeks, 1 week to remove the drug effect after screening and 4 weeks for the clinical study period Persons who do not have a reason to prohibit the use of electrotherapy that can significantly affect biomarkers in relation to this study A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial Exclusion Criteria: Those who have been diagnosed with sleep arousal disorders other than insomnia (hypersomnia disorder, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep arousal disorder, parasomnia) Those who have insomnia due to physical illness or medications being taken Patients with major medical and neuropsychiatric diseases other than sleep disorders Persons who have had or are currently undergoing dental treatment with a history of implanting metallic materials into the upper body, such as the transcranial or face, neck, etc., where non-invasive electrical stimulation is difficult or impossible Compliance was evaluated by writing a sleep diary for 1 week from the start of treatment, and if a sleep diary of 3 days or less was kept for 1 week, it was excluded from the study. Those who have changed the type and dose of drugs used within the last 3 months, or the type and time of cognitive behavioral therapy If you are currently registered in another clinical trial or use another clinical trial drug or device within 60 days from the time of screening 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.) Those with less than 8 points based on the Korean version of Insomnia severity index (ISI-K) When writing a sleep diary for a week, if it is written for less than 3 days or has an irregular sleep schedule

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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 | Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B<br>* 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<br>|
| Sham Comparator: Control group<br>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 | Device: Sham Stimulation using YPS-401B<br>* A device that is attached in the same way as a real medical device, but actually applies a shum stimulus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Insomnia Severity Index (ISI) | Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment: | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous electric nerve stimulation, TENS, Insomnia, Trigeminal nerve stimulation