Nerve; Disorder, SympatheticNCT03243448
Skin Sympathetic Nerve Activity and Sympathetic Tone
An observational study of Nerve; Disorder, Sympathetic and Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
There are many sympathetic hyperactivity diseases in the investigators' clinical practice. However, the conventional method to measure the sympathetic nerve activity had many limitations such as clinical application, data interpretation and even therapeutic manipulation. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve; Disorder, Sympathetic, Healthy
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Jul 2032
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects who are eligible to the inclusion criteria and admitted to the investigators' ward, visited the investigators' outpatient clinic or health checkup center will be enrolled in the investigators' study.
Who may be able to join
- Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.
- Healthy Volunteers
Who cannot join
- Pregnant
About this study
Official title: Using Skin Sympathetic Nerve Activity to Estimate Sympathetic Tone in Human
There are many sympathetic hyperactivity diseases in the investigators' clinical practice. However, the conventional method to measure the sympathetic nerve activity had many limitations such as clinical application, data interpretation and even therapeutic manipulation. Therefore the investigators would like to develop a non-invasive method to record the sympathetic nerve activity in the investigators' study that can help gathering the sympathetic nerve activity easily in the investigators' daily clinical situation. By the determination of sympathetic nerve activity status, the health caregiver can understand the disease more.
- Conditions
- Nerve; Disorder, Sympathetic, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The general public | people between 20-85 years old, without sympathetic hyperactivity disease | |
| Sympathetic hyperactivity diseases | Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Sympathetic Nerve Activity
The Sympathetic Nerve Activity Recording from the skin of the subjects in the day time.
Measured: 12 hours
Secondary outcomes (3)
ventricular arrhythmia
The electrocardiogram recording from the telemetry.
Measured: 24 to 72 hours
Mortality
The mortality will be accessed by the chart review and telephone access
Measured: 1 to 12 months
Morbidity
The morbidity will be accessed by the chart review and telephone access
Measured: 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nerve; Disorder, SympatheticStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243448
- Sponsor's protocol ID
- KMU-DK106011
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2017
- Last updated
- 10 Aug 2026
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Shen MJ, Coffey AC, Straka S, Adams DE, Wagner DB, Kovacs RJ, Clark M, Shen C, Chen LS, Everett TH 4th, Lin SF, Chen PS. Simultaneous recordings of intrinsic cardiac nerve activity and skin sympathetic nerve activity from human patients during the postoperative period. Heart Rhythm. 2017 Nov;14(11):1587-1593. doi: 10.1016/j.hrthm.2017.06.030. Epub 2017 Jun 23.
PubMed 28648667Everett TH 4th, Doytchinova A, Cha YM, Chen PS. Recording sympathetic nerve activity from the skin. Trends Cardiovasc Med. 2017 Oct;27(7):463-472. doi: 10.1016/j.tcm.2017.05.003. Epub 2017 May 10.
PubMed 28619579Uradu A, Wan J, Doytchinova A, Wright KC, Lin AYT, Chen LS, Shen C, Lin SF, Everett TH 4th, Chen PS. Skin sympathetic nerve activity precedes the onset and termination of paroxysmal atrial tachycardia and fibrillation. Heart Rhythm. 2017 Jul;14(7):964-971. doi: 10.1016/j.hrthm.2017.03.030. Epub 2017 Mar 24.
PubMed 28347833Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.
PubMed 27670627Tang CL, Tsai WC, Lee JY, Wang YK, Chen YH, Liu YW, Lin MC, Fang PT, Huang YL, Wu IC. Higher pre-treatment skin sympathetic nerve activity and elevated resting heart rate after chemoradiotherapy predict worse esophageal cancer outcomes. BMC Cancer. 2022 Oct 22;22(1):1086. doi: 10.1186/s12885-022-10180-8.
PubMed 36271384Huang TC, Lin SJ, Chen CJ, Jhuo SJ, Chang CW, Lin SC, Chi NY, Chou LF, Tai LH, Liu YH, Lin TH, Liao WS, Kao PH, Cheng MC, Hsu PC, Lee CS, Lin YH, Lee HC, Lu YH, Yen HW, Lin TH, Su HM, Lai WT, Dai CY, Lee CH, Chen PS, Lin SF, Tsai WC. Skin sympathetic nerve activity and ventricular arrhythmias in acute coronary syndrome. Heart Rhythm. 2022 Oct;19(10):1613-1619. doi: 10.1016/j.hrthm.2022.04.031. Epub 2022 May 5.
PubMed 35525422
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Skin Sympathetic Nerve Activity to Estimate Sympathetic Tone in Human
- ClinicalTrials.gov ID
- NCT03243448
- Acronym / sponsor ID
- KMU-DK106011
- Conditions
- Nerve; Disorder, Sympathetic, Healthy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 9 Aug 2017 (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.
There are many sympathetic hyperactivity diseases in the investigators' clinical practice. However, the conventional method to measure the sympathetic nerve activity had many limitations such as clinical application, data interpretation and even therapeutic manipulation. Therefore the investigators would like to develop a non-invasive method to record the sympathetic nerve activity in the investigators' study that can help gathering the sympathetic nerve activity easily in the investigators' daily clinical situation. By the determination of sympathetic nerve activity status, the health caregiver can understand the disease more.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The general public | – | –people between 20-85 years old, without sympathetic hyperactivity disease |
| Sympathetic hyperactivity diseases | – | –Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects who are eligible to the inclusion criteria and admitted to the investigators' ward, visited the investigators' outpatient clinic or health checkup center will be enrolled in the investigators' study.
Key inclusion criteria (2 listed)
- Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.
- Healthy Volunteers
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin Sympathetic Nerve Activity
Time frame: 12 hours
The Sympathetic Nerve Activity Recording from the skin of the subjects in the day time.
3 secondary outcomes
ventricular arrhythmia
Time frame: 24 to 72 hours
Mortality
Time frame: 1 to 12 months
Morbidity
Time frame: 1 to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 28648667Shen MJ, Coffey AC, Straka S, Adams DE, Wagner DB, Kovacs RJ, Clark M, Shen C, Chen LS, Everett TH 4th, Lin SF, Chen PS. Simultaneous recordings of intrinsic cardiac nerve activity and skin sympathetic nerve activity from human patients during the postoperative period. Heart Rhythm. 2017 Nov;14(11):1587-1593. doi: 10.1016/j.hrthm.2017.06.030. Epub 2017 Jun 23.
- Results publication: PubMed 28619579Everett TH 4th, Doytchinova A, Cha YM, Chen PS. Recording sympathetic nerve activity from the skin. Trends Cardiovasc Med. 2017 Oct;27(7):463-472. doi: 10.1016/j.tcm.2017.05.003. Epub 2017 May 10.
- Results publication: PubMed 28347833Uradu A, Wan J, Doytchinova A, Wright KC, Lin AYT, Chen LS, Shen C, Lin SF, Everett TH 4th, Chen PS. Skin sympathetic nerve activity precedes the onset and termination of paroxysmal atrial tachycardia and fibrillation. Heart Rhythm. 2017 Jul;14(7):964-971. doi: 10.1016/j.hrthm.2017.03.030. Epub 2017 Mar 24.
- Results publication: PubMed 27670627Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.
- Derived from this study: PubMed 36271384Tang CL, Tsai WC, Lee JY, Wang YK, Chen YH, Liu YW, Lin MC, Fang PT, Huang YL, Wu IC. Higher pre-treatment skin sympathetic nerve activity and elevated resting heart rate after chemoradiotherapy predict worse esophageal cancer outcomes. BMC Cancer. 2022 Oct 22;22(1):1086. doi: 10.1186/s12885-022-10180-8.
- Derived from this study: PubMed 35525422Huang TC, Lin SJ, Chen CJ, Jhuo SJ, Chang CW, Lin SC, Chi NY, Chou LF, Tai LH, Liu YH, Lin TH, Liao WS, Kao PH, Cheng MC, Hsu PC, Lee CS, Lin YH, Lee HC, Lu YH, Yen HW, Lin TH, Su HM, Lai WT, Dai CY, Lee CH, Chen PS, Lin SF, Tsai WC. Skin sympathetic nerve activity and ventricular arrhythmias in acute coronary syndrome. Heart Rhythm. 2022 Oct;19(10):1613-1619. doi: 10.1016/j.hrthm.2022.04.031. Epub 2022 May 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve; Disorder, Sympathetic and Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 1 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: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Skin Sympathetic Nerve Activity (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03243448, which also lists 6 linked publications.
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 10 Aug 2026.