Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Bundang Hospital

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

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

Seoul National University Bundang Hospital

Lead sponsor

National Research Foundation of Korea

Collaborator