Postural Tachycardia SyndromeNCT02329548
Qualitative Sweat Distribution During Tilt Table Procedure
A study testing Alizarin Red in people with Postural Tachycardia Syndrome and Syncope, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Postural Tachycardia Syndrome, Syncope, Anxiety
- What is being tested?
- Alizarin Red
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital, neurology outpatient clinic
Columbus, Ohio, 43205
About this study
Official title: Qualitative Sweat Distribution Among Youth With Postural Tachycardia Syndrome (POTS), Syncope, or Anxiety
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).
Read the 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
- Being tested
- Alizarin Red
- Keywords
- Alizarin, Orthostatic, POTS, Tilt table testing, Syncope, Anxiety
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Syncope, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alizarin RedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alizarin Red | Experimental | All participating patients will undergo the Alizarin Red intervention. Receives: Other: Alizarin Red |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 30 minutes
Secondary outcomes (1)
Sweat distribution among patients with POTS assessed by serial photography
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).
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Heyer, Nationwide Children's Hospital
- Investigators
- Geoffrey L. Heyer, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329548
- Sponsor's protocol ID
- IRB14-00528
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Sweat Distribution Among Youth With Postural Tachycardia Syndrome (POTS), Syncope, or Anxiety
- ClinicalTrials.gov ID
- NCT02329548
- Acronym / sponsor ID
- IRB14-00528
- Conditions
- Postural Tachycardia Syndrome, Syncope, Anxiety
- Keywords
- Alizarin, Orthostatic, POTS, Tilt table testing, Syncope, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alizarin Red | Experimental | Other: Alizarin RedAll participating patients will undergo the Alizarin Red intervention. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alizarin RedAn 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. | Other | Alizarin Red |
Primary outcome
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).
1 secondary outcome
Sweat distribution among patients with POTS assessed by serial photography
Time frame: Up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Related trials for Postural Tachycardia Syndrome
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Active, not recruitingPhase 1/2
Treatment of Orthostatic Intolerance
Tachycardia, Chronic Orthostatic Intolerance
Active, not recruiting
Acute Salt Handling in Orthostatic Intolerance
Postural Tachycardia Syndrome, Orthostatic Tachycardia
Active, not recruiting
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey L. Heyer, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alizarin Red in people with Postural Tachycardia Syndrome and Syncope, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic versus emotional sweat distribution assessed by serial photography (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.