Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04884607

Enrollment

Registered

2021-05-13

Start date

2021-08-01

Completion date

2022-02-28

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia, Cardiovascular Diseases

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.

Interventions

OTHERsubthreshold 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026