Cardiac ArrhythmiaNCT04884607
Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
A study testing subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes in people with Cardiac Arrhythmia and Cardiovascular Diseases, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia, Cardiovascular Diseases
- What is being tested?
- subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults without cardiovascular diseases
- Aged 20 years or more with Informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
- 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
- Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
- 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.
- Conditions
- Cardiac Arrhythmia, Cardiovascular Diseases
- Being tested
- subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subthreshold low-level autonomic nerve stimulation using external auditory canal electrodesOther
- 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 group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes. Receives: Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Selected parameters of heart rate variability
Measured: Through study completion, an average of within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seil Oh, Seoul National University Hospital
- Investigators
- Seil Oh, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884607
- Sponsor's protocol ID
- H-2104-191-1214
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be available upon appropriateness of the request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
- ClinicalTrials.gov ID
- NCT04884607
- Acronym / sponsor ID
- H-2104-191-1214
- Conditions
- Cardiac Arrhythmia, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: subthreshold low-level autonomic nerve stimulation using external auditory canal electrodesStudy group will receive subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults without cardiovascular diseases
- Aged 20 years or more with Informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study group |
Primary outcome
Heart rate variability
Time frame: Through study completion, an average of within 1 day
Selected parameters of heart rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided. IPD will be available upon appropriateness of the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seil Oh, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes in people with Cardiac Arrhythmia and Cardiovascular Diseases, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Through study completion, an average of within 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.