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

September 19, 2022 updated by: Ybrain Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Insomnia Severity Index (ISI)
Time Frame: after 4 weeks
Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment:
after 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Remission rate of ISI
Time Frame: after 4 weeks
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
Time Frame: after 4 weeks
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)
Time Frame: after 4 weeks
Changes in Pittsburgh Slepp Quality Index (PSQI) after 4 weeks compared to before treatment
after 4 weeks
Changes in index of slepp diary
Time Frame: after 4 weeks
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
Time Frame: after 4 weeks
Changes in EEG index (absolute power, relative power) after 4 weeks compared to before treatment
after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ybrain Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Bundang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Changho Yoon, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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