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Qualitative Sweat Distribution During Tilt Table Procedure

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ClinicalTrials.gov Identifier: NCT02329548
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Geoffrey Heyer, Nationwide Children's Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Syncope Anxiety Other: Alizarin Red Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Qualitative Sweat Distribution Among Youth With Postural Tachycardia Syndrome (POTS), Syncope, or Anxiety
Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fainting Sweat

Arm Intervention/treatment
Experimental: Alizarin Red
All participating patients will undergo the Alizarin Red intervention.
Other: Alizarin Red
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.




Primary Outcome Measures :
  1. Orthostatic versus emotional sweat distribution assessed by serial photography [ Time Frame: Up to 30 minutes ]
    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 sweat).


Secondary Outcome Measures :
  1. Sweat distribution among patients with POTS assessed by serial photography [ Time Frame: Up to 30 minutes ]
    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).



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329548


Locations
United States, Ohio
Nationwide Children's Hospital, neurology outpatient clinic
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Geoffrey L. Heyer, MD Nationwide Children's Hospital

Responsible Party: Geoffrey Heyer, Assistant Professor of Neurology and Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02329548     History of Changes
Other Study ID Numbers: IRB14-00528
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Geoffrey Heyer, Nationwide Children's Hospital:
Alizarin
Orthostatic
POTS
Tilt table testing
Syncope
Anxiety

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Anxiety Disorders
Syncope
Disease
Pathologic Processes
Mental Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases