Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
NCT04884607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-04-18
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
1. Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
2. 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.
3. 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.
Conditions
- Cardiac Arrhythmia
- Cardiovascular Diseases
Interventions
- OTHER
-
subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes
* 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.
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Seil Oh, MD, PhD · Seoul National University Hospital
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-02-28
Countries
- South Korea
Study Locations
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