Actively Recruiting
Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
Led by Seoul National University Bundang Hospital · Updated on 2026-03-12
28
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
N
National Research Foundation of Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, South Korea, 463-707
Actively Recruiting
Research Team
J
Juseok Ryu, M.D., Ph.D.
CONTACT
H
Hyunjin KIM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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