Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Study Overview
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Brief Summary
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Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants Study design Prospective, single-center, interventional, single-arm design Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited. Study methods Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared. Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.

Official Title
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Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Conditions
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Cardiac Arrhythmia, Cardiovascular Diseases

Intervention / Treatment
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* Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults without cardiovascular diseases Aged 20 years or more with Informed consent Exclusion Criteria: Patients with autonomic disorder, cardiovascular drug prescriptions, cardiovascular diseases, diabetes, or with cardiac implantable electronic devices Patients with abnormalities at both external auditory canals and ears

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes. | Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes<br>* Evaluation of electrocardiogram measurement from external auditory canal electrodes: Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared. Evaluation of low-level autonomic nerve stimulation using external auditory canal: Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Selected parameters of heart rate variability | Through study completion, an average of within 1 day |