NCT07466888

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

Reduced tone and weakness of the genioglossus muscle are critical factors in the pathophysiology of obstructive sleep apnea (OSA). In addition to the genioglossus, other upper airway-related muscles, including the thyrohyoid and additional infrahyoid muscles, contribute to airway stability. These muscles differ in anatomical depth from the skin surface and in muscle thickness, which necessitates differentiated electrical stimulation approaches to ensure selective activation and safety.This clinical trial is designed to evaluate the safety and efficacy of functional electrical stimulation (FES) applied to the genioglossus muscle with modulation of stimulation frequency. The study aims to determine whether frequency adjustment influences muscle morphology and functional outcomes.The primary objective is to assess frequency-dependent changes in muscle length and thickness using ultrasonography, as well as differences in tongue strength measured by the Iowa Oral Performance Instrument (IOPI) before and after electrical stimulation.The secondary objective is to evaluate discomfort, safety, and subjective treatment effects through questionnaires administered before and after the electrical stimulation intervention.

Conditions

• Obstructive Sleep Apnea (OSA)
• Snoring

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-06
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: South Korea