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

NCT05546112 | Unknown

• 1 other identifier: YB-05
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Transcutaneous electric nerve stimulation, TENS; Insomnia; Trigeminal nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Insomnia Severity Index (ISI)

  Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment:

  after 4 weeks

Secondary Outcomes (5)

• Remission rate of ISI

  after 4 weeks

• Response rate of ISI

  after 4 weeks

• Changes in Pittsburgh Slepp Quality Index (PSQI)

  after 4 weeks

• Changes in index of slepp diary

  after 4 weeks

• Changes in EEG index

  after 4 weeks

Study Arms (2)

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

Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B

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

Device: Sham Stimulation using YPS-401B

Interventions

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

Experimental group

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

Control group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ybrain Inc.: lead
• Seoul National University Bundang Hospital: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Changho Yoon, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiwon Lee, PhD

CONTACT

+82-535-2871; clinical.trials@ybrain.com

Jinuk Kim, PhD

CONTACT

+82-10-5185-4561; jinuk.kim@ybrain.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: October 4, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09