Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04884607

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia Cardiovascular Diseases	Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group 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 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.

Arm

Intervention/Treatment

Experimental: Study group

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

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.

Outcome Measures

Primary Outcome Measures

Heart rate variability [Through study completion, an average of within 1 day]
Selected parameters of heart rate variability

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Seil Oh, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seil Oh, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04884607

Other Study ID Numbers:

H-2104-191-1214

First Posted:

May 13, 2021

Last Update Posted:

Jul 26, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 26, 2021