- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329548
Qualitative Sweat Distribution During Tilt Table Procedure
Qualitative Sweat Distribution Among Youth With Postural Tachycardia Syndrome (POTS), Syncope, or Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital, neurology outpatient clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alizarin Red
All participating patients will undergo the Alizarin Red intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Geoffrey L. Heyer, MD, Nationwide Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Unconsciousness
- Consciousness Disorders
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Anxiety Disorders
- Tachycardia
- Syncope
- Postural Orthostatic Tachycardia Syndrome
Other Study ID Numbers
- IRB14-00528
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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