Qualitative Sweat Distribution During Tilt Table Procedure

NCT ID: NCT02329548

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-12-31

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).

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.

Conditions

Postural Tachycardia Syndrome; Syncope; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Alizarin Red

All participating patients will undergo the Alizarin Red intervention.

Group Type: EXPERIMENTAL

Alizarin Red

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geoffrey Heyer

Assistant Professor of Neurology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffrey L. Heyer, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital, neurology outpatient clinic

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB14-00528

Identifier Type: -

Identifier Source: org_study_id