MedTrace Logo

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

NCT05546112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-22

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Ybrain Inc.

    lead INDUSTRY

Principal Investigators

  • Changho Yoon, MD, PhD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2022-12-31
Completion
2022-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546112 on ClinicalTrials.gov