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

NCT ID: NCT05546112

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Sham Stimulation using YPS-401B

Intervention Type: DEVICE

A device that is attached in the same way as a real medical device, but actually applies a shum stimulus

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Ybrain Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changho Yoon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Central Contacts

Kiwon Lee, PhD

Role: CONTACT

clinical.trials@ybrain.com

+82-535-2871

Jinuk Kim, PhD

Role: CONTACT

jinuk.kim@ybrain.com

+82-10-5185-4561

Other Identifiers

YB-05

Identifier Type: -

Identifier Source: org_study_id