Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
Healthy Volunteers
NCT07466888

Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity

Led by Seoul National University Bundang Hospital · Updated on 2026-03-12

28

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Bundang Hospital

Lead Sponsor

N

National Research Foundation of Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

This single-group interventional study investigates the safety and physiologic effects of functional electrical stimulation (FES) applied to the tongue and submental muscles in adults at high risk for sleep apnea. Participants will receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order during a single visit. Ultrasound and tongue pressure (IOPI) measurements, as well as subjective assessments of discomfort and perceived effects, will be conducted before, during, and after stimulation. The primary objective is to evaluate changes in muscle thickness, length, and tongue strength across different stimulation frequencies. Secondary objectives include assessing participant discomfort, safety, and subjective treatment effects.

CONDITIONS

Official Title

Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older
  • STOP questionnaire score ≥ 2
  • Able to read and write in Korean
  • Voluntarily provides written informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Refusal to undergo study procedures or failure to provide informed consent
  • Cognitive impairment or psychiatric disorders that interfere with the ability to follow study instructions
  • Pregnant or breastfeeding women
  • Known allergy or hypersensitivity to electrical stimulation pads or related materials (e.g., silicone, polypropylene, polyethylene)
  • Skin conditions preventing application of electrical stimulation (e.g., hypersensitive skin)
  • Medical conditions considered unsuitable for participation by the investigator (e.g., epilepsy, malignant tumor, high fever, diabetes mellitus, use of anticoagulants, phlebitis, thrombophlebitis, hemophilia)
  • Infectious disease or local conditions at the stimulation site (e.g., inflammation, wounds, abscess, edema)
  • Known cardiac disease or presence of a cardiac pacemaker or implanted electrical stimulation device
  • History of surgery involving the submental area or upper airway region

AI-Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea, 463-707

Actively Recruiting

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Research Team

J

Juseok Ryu, M.D., Ph.D.

CONTACT

H

Hyunjin KIM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity | DecenTrialz