NCT07466888 Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
| NCT ID | NCT07466888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2026-01-06 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jee Hyun Suh, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT07466888 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07466888 currently recruiting?
Yes, NCT07466888 is actively recruiting participants. Contact the research team at jseok337@snu.ac.kr for enrollment information.
Where is the NCT07466888 trial being conducted?
This trial is being conducted at Gyeonggi-do, South Korea.
Who is sponsoring the NCT07466888 clinical trial?
NCT07466888 is sponsored by Seoul National University Bundang Hospital. The principal investigator is Jee Hyun Suh, M.D., Ph.D. at Seoul National University Bundang Hospital. The trial plans to enroll 28 participants.