Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-02-28

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Cardiac Arrhythmia Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes

Intervention Type OTHER

* 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes