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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-frequency Functional Electrical Stimulation | Experimental | All participants receive a single-session multi-frequency functional electrical stimulation protocol (15-75 Hz) applied in randomized order. Ultrasound and tongue pressure (IOPI) measurements are performed before and after stimulation, while subjective assessments of discomfort and perceived effects are collected during each stimulation frequency. Participants are blinded to stimulation frequency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and immediately after stimulation at each frequency during a single study visit (~1 hour) |
| 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. | Before and immediately after stimulation at each frequency during a single study visit (~1 hour) |
| 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. | Before stimulation and immediately after completion of all frequency conditions during a single study visit (~1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juseok Ryu, M.D., Ph.D. | Contact | +82-31-787-7739 | jseok337@snu.ac.kr | |
| Hyunjin KIM | Contact | +82-10-9974-7152 |
| Name | Affiliation | Role |
|---|---|---|
| Jee Hyun Suh, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | Seongnam-si | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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.
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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.
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| During each stimulation frequency and immediately after completion of all frequency conditions during a single study visit (~1 hour) |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |