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RECRUITING
NCT07466888
NA

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

Sponsor: Seoul National University Bundang Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-01-06

Completion Date

2026-04

Last Updated

2026-03-12

Healthy Volunteers

Yes

Interventions

DEVICE

Functional Electrical Stimulation Device

A functional electrical stimulation device is applied to the submental region using surface adhesive electrodes. Stimulation is delivered at five different frequencies (15, 25, 35, 45, and 75 Hz) in randomized sequence during a single study visit. Each frequency is administered within the same session to evaluate immediate physiologic responses of the tongue muscles. Participants are blinded to the stimulation frequency applied during each condition.

Locations (1)

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea