Obstructive Sleep Apnea (OSA), Snoring
Conditions
Keywords
Obstructive Sleep Apnea (OSA), Snoring, FES
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.
Detailed description
Reduced tone and weakness of the genioglossus muscle are critical factors in the pathophysiology of obstructive sleep apnea (OSA). In addition to the genioglossus, other upper airway-related muscles, including the thyrohyoid and additional infrahyoid muscles, contribute to airway stability. These muscles differ in anatomical depth from the skin surface and in muscle thickness, which necessitates differentiated electrical stimulation approaches to ensure selective activation and safety.This clinical trial is designed to evaluate the safety and efficacy of functional electrical stimulation (FES) applied to the genioglossus muscle with modulation of stimulation frequency. The study aims to determine whether frequency adjustment influences muscle morphology and functional outcomes.The primary objective is to assess frequency-dependent changes in muscle length and thickness using ultrasonography, as well as differences in tongue strength measured by the Iowa Oral Performance Instrument (IOPI) before and after electrical stimulation.The secondary objective is to evaluate discomfort, safety, and subjective treatment effects through questionnaires administered before and after the electrical stimulation intervention.
Interventions
DEVICEFunctional Electrical Stimulation 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.
Sponsors
Seoul National University Bundang Hospital
National Research Foundation of Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
This is an open-label study. Both participants and investigators are aware that functional electrical stimulation is administered during the study session. No sham stimulation or separate comparison group is included.
Intervention model description
This is a single-group interventional study in which all participants undergo a multi-frequency functional electrical stimulation protocol during a single study visit. The protocol includes five stimulation frequencies (15, 25, 35, 45, and 75 Hz) applied in randomized order within the same session. Outcomes are assessed before, during, and immediately after stimulation to evaluate within-subject physiologic responses.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in genioglossus muscle thickness measured by ultrasonography | Before and immediately after stimulation at each frequency during a single study visit (~1 hour) | 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. |
| Change in genioglossus muscle length measured by ultrasonography | Before and immediately after stimulation at each frequency during a single study visit (~1 hour) | 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. |
| Change in tongue strength measured by the Iowa Oral Performance Instrument (IOPI) | Before stimulation and immediately after completion of all frequency conditions during a single study visit (~1 hour) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-reported discomfort associated with electrical stimulation | During each stimulation frequency and immediately after completion of all frequency conditions during a single study visit (~1 hour) | 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. |
Countries
South Korea
Contacts
CONTACTJuseok Ryu, M.D., Ph.D.
CONTACTHyunjin KIM
PRINCIPAL_INVESTIGATORJee Hyun Suh, M.D., Ph.D.
Seoul National University Bundang Hospital
Outcome results
None listed