Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Seoul National University

Status: Completed

Conditions: Cardiovascular Diseases; Cardiac Arrhythmia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04884607

H-2104-191-1214

Details and patient eligibility

About

• 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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Study group

Experimental group

Description:

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

Treatment:

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