Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Not Applicable

Completed

• Conditions: Cardiac Arrhythmia; Cardiovascular Diseases
• Interventions: Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes

• Registration Number: NCT04884607
• Lead Sponsor: Seoul National University Hospital

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

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-13
• Study Start: 2021-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Heart rate variability	Through study completion, an average of within 1 day	Selected parameters of heart rate variability

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of