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Clinical Trials in South Korea / NCT07466888
Recruiting Not applicable

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

NCT07466888 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Bundang Hospital
Phase
Not applicable
Started
2026-01-06
Last updated
2026-03-12

Condition(s) studied

Obstructive Sleep Apnea (OSA)Snoring

Investigational drug(s) / intervention(s)

Functional Electrical Stimulation 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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in genioglossus muscle thickness measured by ultrasonography — Before and immediately after stimulation at each frequency during a single study visit (~1 hour)
    The thickness of the genioglossus muscle is measured using ultrasonography before and immediately after electrical stimulation at each frequency (15, 25, 35, 45, and 75 Hz) during a single study visit.
  • Change in genioglossus muscle length measured by ultrasonography — Before and immediately after stimulation at each frequency during a single study visit (~1 hour)
    The length of the genioglossus muscle is measured using ultrasonography before and immediately after electrical stimulation at each frequency (15, 25, 35, 45, and 75 Hz) during a single study visit.
  • Change in tongue strength measured by the Iowa Oral Performance Instrument (IOPI) — Before stimulation and immediately after completion of all frequency conditions during a single study visit (~1 hour)
    Tongue strength is measured using the Iowa Oral Performance Instrument (IOPI) in kilopascals (kPa) before electrical stimulation and immediately after completion of all frequency conditions during a single study visit (\~1 hour). IOPI scores range from 0 kPa (no measurable pressure) to approximately 70 kPa (maximum tongue strength), with higher scores indicating greater tongue strength.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Gyeonggi-do Seongnam-si Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07466888 on ClinicalTrials.gov ↗ ← All trials in South Korea