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Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Primary Purpose

Cardiac Arrhythmia, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Arrhythmia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes.

Outcomes

Primary Outcome Measures

Heart rate variability
Selected parameters of heart rate variability

Secondary Outcome Measures

Full Information

First Posted
May 10, 2021
Last Updated
April 14, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04884607
Brief Title
Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
Official Title
Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia, Cardiovascular Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes.
Intervention Type
Other
Intervention Name(s)
subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Selected parameters of heart rate variability
Time Frame
Through study completion, an average of within 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seil Oh, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be available upon appropriateness of the request.

Learn more about this trial

Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

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