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New treatment option for Obstructive Sleep Apnea (OSA)
Official title Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity
ClinicalTrials.gov ID: NCT07466888
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gyeonggi-do, Seongnam-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gyeonggi-do, Seongnam-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.