Qualitative Sweat Distribution During Tilt Table Procedure

NCT02329548 | Completed

• 1 other identifier: IRB14-00528
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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).

Conditions

Postural Tachycardia Syndrome; Syncope; Anxiety

Keywords

Alizarin; Orthostatic; POTS; Tilt table testing; Syncope; Anxiety

Outcome Measures

Primary Outcomes (1)

• Orthostatic versus emotional sweat distribution assessed by serial photography

  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).

  Up to 30 minutes

Secondary Outcomes (1)

• Sweat distribution among patients with POTS assessed by serial photography

  Up to 30 minutes

Study Arms (1)

Alizarin Red

EXPERIMENTAL

All participating patients will undergo the Alizarin Red intervention.

Other: Alizarin Red

Interventions

Alizarin Red 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.

Alizarin Red

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must have prior documented sweat response from tilt table testing in our laboratory.
• Must speak English well enough to describe orthostatic symptoms and imminent syncope.

You may not qualify if:

• Pregnancy
• Somatic or psychiatric illness that precludes tilt table testing
• Skin defect or rash that precludes application of Alizarin Red powder
• Known sweat disorder of any type
• Long QT syndrome

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital, neurology outpatient clinic

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Syncope; Anxiety Disorders

Interventions

alizarin

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Geoffrey L. Heyer, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Pediatrics

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)