Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in genioglossus muscle thickness measured by ultrasonography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Multi-frequency Functional Electrical Stimulation
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.
干预措施: Functional Electrical Stimulation Device (Device)
结局指标
主要结局
Change in genioglossus muscle thickness measured by ultrasonography
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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))
研究者
JeeHyun Suh
Professor
Seoul National University Bundang Hospital