Obstructive Sleep Apnea Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Gyeonggi-do
Contact Information
Primary
Juseok Ryu, M.D., Ph.D.
jseok337@snu.ac.kr
+82-31-787-7739
Backup
Hyunjin KIM
+82-10-9974-7152
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2026-04
Participants
Target number of participants: 28
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Research Foundation of Korea
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov