Clinical trial NCT03243448: Skin Sympathetic Nerve Activity and Sympathetic Tone
Official title: Using Skin Sympathetic Nerve Activity to Estimate Sympathetic Tone in Human
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nerve; Disorder, Sympathetic
Healthy
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Skin Sympathetic Nerve Activity
timeFrame: 12 hours
Secondary outcomes:
measure: ventricular arrhythmia
timeFrame: 24 to 72 hours
measure: Mortality
timeFrame: 1 to 12 months
measure: Morbidity
timeFrame: 1 to 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Everett 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.
citation: Uradu 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.
citation: Doytchinova 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.
citation: Tang 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.
citation: Huang 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.