Health TrialsbyHealthPanel

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

ConditionsObstructive Sleep Apnea (OSA)Snoring
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Functional Electrical Stimulation Device

    Device

    A functional electrical stimulation device is applied to the submental region using surface adhesive electrodes. Stimulation is delivered at five different frequencies (15, 25, 35, 45, and 75 Hz) in randomized sequence during a single study visit. Each frequency is administered within the same session to evaluate immediate physiologic responses of the tongue muscles. Participants are blinded to the stimulation frequency applied during each condition.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Multi-frequency Functional Electrical StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in genioglossus muscle thickness measured by ultrasonography

The thickness of the genioglossus muscle is measured using ultrasonography before and immediately after electrical stimulation at each frequency (15, 25, 35, 45, and 75 Hz) during a single study visit.

Time frame
Before and immediately after stimulation at each frequency during a single study visit (~1 hour)
2

Change in genioglossus muscle length measured by ultrasonography

The length of the genioglossus muscle is measured using ultrasonography before and immediately after electrical stimulation at each frequency (15, 25, 35, 45, and 75 Hz) during a single study visit.

Time frame
Before and immediately after stimulation at each frequency during a single study visit (~1 hour)
3

Change in tongue strength measured by the Iowa Oral Performance Instrument (IOPI)

Tongue strength is measured using the Iowa Oral Performance Instrument (IOPI) in kilopascals (kPa) before electrical stimulation and immediately after completion of all frequency conditions during a single study visit (\~1 hour). IOPI scores range from 0 kPa (no measurable pressure) to approximately 70 kPa (maximum tongue strength), with higher scores indicating greater tongue strength.

Time frame
Before stimulation and immediately after completion of all frequency conditions during a single study visit (~1 hour)

Secondary outcomes

1

Participant-reported discomfort associated with electrical stimulation

Participant discomfort is assessed using a 1-5 Likert scale questionnaire during each stimulation frequency and immediately after completion of all frequency conditions during the study visit (\~1 hour). Scale interpretation: 1 = very uncomfortable, 2 = uncomfortable, 3 = neutral, 4 = comfortable, 5 = very comfortable. Higher scores indicate greater comfort.

Time frame
During each stimulation frequency and immediately after completion of all frequency conditions during a single study visit (~1 hour)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

National Research Foundation of Korea

Collaborator

Source ClinicalTrials.gov
Apply now