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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B; Device: Sham Stimulation using YPS-401B

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiwon Lee, PhD; Phone Number: +82-535-2871; Email: clinical.trials@ybrain.com
• Study Contact Backup: Name: Jinuk Kim, PhD; Phone Number: +82-10-5185-4561; Email: jinuk.kim@ybrain.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; 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; 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
SHAM_COMPARATOR: Control group; 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; A device that is attached in the same way as a real medical device, but actually applies a shum stimulus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ybrain Inc.
• Collaborators: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Changho Yoon, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 4, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (ACTUAL): September 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Insomnia; Transcutaneous electric nerve stimulation, TENS; Trigeminal nerve stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: YB-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No