About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Functional Electrical Stimulation Device
Treatment groups
Sponsors and collaborators
Seoul National University Bundang Hospital
Lead sponsor
National Research Foundation of Korea
Collaborator