Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884607
• Other study ID #: H-2104-191-1214
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Selected parameters of heart rate variability	Through study completion, an average of within 1 day