Changing electrical stimulation frequency to affect tongue muscle activity
Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
This test tries different electrical stimulation frequencies on the tongue and submental muscles to see if they change tongue strength and muscle size in adults at high risk for sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Gyeonggi-do, Seongnam-si) |
| Trial ID | NCT07466888 on ClinicalTrials.gov |
What this trial studies
This single-group interventional study applies functional electrical stimulation (FES) to the genioglossus and nearby submental muscles during a single clinic visit. Participants receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order while ultrasound measurements, tongue pressure (IOPI) tests, and subjective discomfort ratings are recorded before, during, and after stimulation. The primary outcomes are frequency-related changes in muscle thickness, length, and tongue strength, with secondary outcomes of participant-reported effects and safety. The protocol focuses on short-term physiologic responses to guide selective and safe activation of upper airway muscles.
Who should consider this trial
Good fit: Adults aged 19 or older who are at high risk for obstructive sleep apnea (STOP score ≥ 2), can read Korean, and have no contraindications to electrical stimulation are ideal candidates.
Not a fit: People who are pregnant, have skin conditions or allergies to stimulation materials, major medical or psychiatric contraindications, or implanted electrical devices are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help personalize FES settings to improve tongue strength and upper airway stability, potentially reducing snoring and the severity of obstructive sleep apnea.
How similar studies have performed: Prior small studies and hypoglossal nerve stimulation approaches have shown benefits for airway patency and snoring, but frequency-specific modulation of the genioglossus with surface FES is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gyeonggi-do, Seongnam-si
- Seoul National University Bundang Hospital — Gyeonggi-do, Seongnam-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Jee Hyun Suh, M.D., Ph.D. — Seoul National University Bundang Hospital
- Study coordinator: Juseok Ryu, M.D., Ph.D.
- Email: jseok337@snu.ac.kr
- Phone: +82-31-787-7739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.