NCT04884607CompletedNot Applicable
Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
Seoul National University Hospital1 site in 1 country12 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Heart rate variability
Study Overview
Brief Summary
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Study group
Experimental
Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes.
Intervention: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes (Other)
Outcomes
Primary Outcomes
Heart rate variability
Time Frame: Through study completion, an average of within 1 day
Selected parameters of heart rate variability
Secondary Outcomes
No secondary outcomes reported
Investigators
Seil Oh
Professor
Seoul National University Hospital
Study Sites (1)
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