RecruitingNot ApplicableNCT07466888

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


Sponsor

Seoul National University Bundang Hospital

Enrollment

28 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Functional Electrical Stimulation Device for people with obstructive sleep apnea (osa) and snoring. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFunctional 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

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NCT07466888


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