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Columbus, Ohio 43205


Purpose:

This study uses an Alizarin Red powder mixture to characterize the sweat distributions in youth during tilt table testing. Patients with a known orthostatic sweat response from a prior clinical tilt table test in the investigators laboratory will be recruited. The Alizarin Red powder will be applied to exposed skin, and quantitative sweat will be measured at the thigh. During tilt testing, serial photos will be taken once the sweat response occurs. Sweat distributions will be compared during syncope (orthostatic sweat), during periods of anxiety (emotional sweat), and in patients with POTS (with and without syncope).


Study summary:

The investigators' laboratory has conducted an exploratory study of quantitative sweat during tilt table testing over the past year. Some patients with Postural Tachycardia Syndrome (POTS) experience excessive sweating. Patients with syncope (without POTS) have an increase in sweat during their tilt-induced syncopal episode. Increased warmth and sweating can be among the first pre-syncopal symptoms in some individuals. Anxiety can also produce a sweat response, so-called "emotional sweating". Emotional sweating tends to affect the palms, soles, and forehead prominently, while the distribution of orthostatic sweat has not been well-described. The investigators' sweat measure quantifies sweat production, but placement of the sweat capsules is limited to four sites on the arms and legs. An Alizarin Red powder mixture applied to exposed skin is brown in color when dry and red in color when moist. Using Alizarin red, a quantitative sweat measure, and serial photography, the investigators will characterize the sweat distribution in patients with syncope, anxiety, and POTS. Patients will be recruited if they had a sweat response from prior tilt table testing performed in the investigators' laboratory. Consenting patients will wear underwear or bathing suits. The investigators will apply Alizarin Red to all exposed skin below the angle of the mandible. A single sweat capsule will be placed at the right hip. Pre-tilt photos will be taken, and then the patient will be tilted head-upright to seventy degrees. Once sweat begins, serial photos will be taken. The patient will remain in the tilted position until syncope occurs or the Alizarin powder is saturated red. If a sweat response is not prominent and syncope does not occur, the patient will be lowered after 30 minutes. The investigators will use the serial photos to describe the temporal distribution of sweat with each patient. Orthostatic sweat can occur before or after syncope, but based on the investigators' prior quantitative sweat measures, there is always an associated drop in blood pressure. The investigators can distinguish emotional from orthostatic sweat based on the patient's self-report of anxiety/panic, the presence of tachypnea, and the absence of syncope or hypotension. The current study aims to characterize sweat production during tilt testing and distinguish orthostatic and emotional sweat distributions. The primary goal of this study is to compare sweat distributions in patients during syncope (orthostatic sweat) and during anxiety (emotional sweat). The secondary goal is to characterize tilt-induced sweat distributions in POTS patients and compare them to the orthostatic and emotional sweat patterns. The investigators hypothesize that emotional sweat will predominantly affect the palms and soles (forehead sweat will not be measured), while orthostatic sweat will have a truncal predominance. This study is significant because the sweat pattern may help to resolve POTS and syncope phenotypes which will ultimately aid in gene discovery for these disorders.


Criteria:

Inclusion Criteria: 1. Must have prior documented sweat response from tilt table testing in our laboratory. 2. Must speak English well enough to describe orthostatic symptoms and imminent syncope. Exclusion Criteria: 1. Pregnancy 2. Somatic or psychiatric illness that precludes tilt table testing 3. Skin defect or rash that precludes application of Alizarin Red powder 4. Known sweat disorder of any type 5. Long QT syndrome


Study is Available At:


Original ID:

IRB14-00528


NCT ID:

NCT02329548


Secondary ID:


Study Acronym:


Brief Title:

Qualitative Sweat Distribution During Tilt Table Procedure


Official Title:

Qualitative Sweat Distribution Among Youth With Postural Tachycardia Syndrome (POTS), Syncope, or Anxiety


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

25 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nationwide Children's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

95


Enrollment Type:

Actual


Overall Contact Information

Official Name:Geoffrey L. Heyer, MD
Principal Investigator
Nationwide Children's Hospital

Study Dates

Start Date:December 2014
Completion Date:December 2016
Completion Type:Actual
Primary Completion Date:December 2016
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 28, 2017
First Received Date:December 12, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Sweat distribution among patients with POTS assessed by serial photography
Time Frame:Up to 30 minutes
Safety Issues:False
Description:Using serial photography the temporal and regional distribution of sweat among POTS patients will be compared to syncope-only patients and patients with anxiety (without hypotension).
Outcome Type:Primary Outcome
Measure:Orthostatic versus emotional sweat distribution assessed by serial photography
Time Frame:Up to 30 minutes
Safety Issues:False
Description:The temporal and regional sweat distributions will be assessed by serial photography. Orthostatic sweat will be distinguished from emotional sweat based on the presence of hypotension/syncope, self-report of anxiety, and presence of tachypnea (emotional s

Study Interventions

Intervention Type:Other
Name:Alizarin Red
Description:An Alizarin Red mixture will be applied to all exposed skin below the angle of the mandible. Once applied the patient will be tilted to 70 degrees. Serial photos will be taken once sweat begins and until conclusion of the test.
Arm Name:Alizarin Red

Study Arms

Study Arm Type:Experimental
Arm Name:Alizarin Red
Description:All participating patients will undergo the Alizarin Red intervention.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Nationwide Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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