Changing electrical stimulation frequency to affect tongue muscle activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.