Neurological DisorderSudoscanNCT03639909
Analysis of the Sweat Response According to the Pathology in Neurologic Patients
An observational study of Neurological Disorder, run by University Hospital, Toulouse.
Trial summary
Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes. CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorder
- What is being tested?
- sweating function and Cardiovascular function
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the autonomic laboratory of the neurology department at Toulouse University Hospital
Who may be able to join
- Patients with MSA-P or PD
Who cannot join
- -
About this study
Official title: Analysis of the Sweat Response According to the Pathology in Neurologic
Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes.
CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing).
First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test
Read the detailed description
Sweat glands are innervated by thin and un myelinated sympathetic C-fibers that can be impaired in neuropathies,especially length-dependent ones. Sweating dysfunction has been shown in several neurological peripheral disorders and it has been suggested that sweating function should be included among the diagnostic tests for the early detection of autonomic neuropathies. Several methods have been developed, but the lack of easy and quick tests to diagnose sweating dysfunction has restricted widespread use in clinical practice. Measurement of electrochemical skin conductance (ESC) using Sudoscan® is a new method for quick, non-invasive and quantitative assessment of sweating. This technique has demonstrated its usefulness in detecting autonomic and small fiber neuropathy, especially in diabetic patients.The aim of this study was to evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction by Sudoscan®, alone or in combination, to differentiate MSA-P from PD. Among the CV tests, the present study particularly looked at those tests already recommended as screening bedside tests in diabetic patients (HR variations with deep breathing and BP variations during stand test) ; these tests are rapid and easy to perform. HR variations with deep breathing depend on parasympathetic tone and BP variations depend on vasomotor sympathetic response.
- Conditions
- Neurological Disorder
- Being tested
- sweating function, Cardiovascular function
- Keywords
- sweat gland
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweating functionProcedure or surgery
Also called sweating dysfunction by Sudoscan
Sweating dysfunction by Sudoscan
Cardiovascular functionProcedure or surgery
Cardiovascular (CV) tests
| Study group | Role | What they receive |
|---|---|---|
| MSA-P | Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function Receives: Procedure: sweating function; Procedure: Cardiovascular function | |
| PD patients | Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function Receives: Procedure: sweating function; Procedure: Cardiovascular function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweating autonomic test
Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Pavy-Le Traon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639909
- Sponsor's protocol ID
- RC31/15/7550
- Acronym
- Sudoscan
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Sweat Response According to the Pathology in Neurologic
- ClinicalTrials.gov ID
- NCT03639909
- Acronym / sponsor ID
- Sudoscan / RC31/15/7550
- Conditions
- Neurological Disorder
- Keywords
- sweat gland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Aug 2018 (actual)
- 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.
Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes.
CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing).
First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test
Detailed description
Sweat glands are innervated by thin and un myelinated sympathetic C-fibers that can be impaired in neuropathies,especially length-dependent ones. Sweating dysfunction has been shown in several neurological peripheral disorders and it has been suggested that sweating function should be included among the diagnostic tests for the early detection of autonomic neuropathies. Several methods have been developed, but the lack of easy and quick tests to diagnose sweating dysfunction has restricted widespread use in clinical practice. Measurement of electrochemical skin conductance (ESC) using Sudoscan® is a new method for quick, non-invasive and quantitative assessment of sweating. This technique has demonstrated its usefulness in detecting autonomic and small fiber neuropathy, especially in diabetic patients.The aim of this study was to evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction by Sudoscan®, alone or in combination, to differentiate MSA-P from PD. Among the CV tests, the present study particularly looked at those tests already recommended as screening bedside tests in diabetic patients (HR variations with deep breathing and BP variations during stand test) ; these tests are rapid and easy to perform. HR variations with deep breathing depend on parasympathetic tone and BP variations depend on vasomotor sympathetic response.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSA-P | – | Procedure: sweating function, Procedure: Cardiovascular functionPatients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function |
| PD patients | – | Procedure: sweating function, Procedure: Cardiovascular functionParkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the autonomic laboratory of the neurology department at Toulouse University Hospital
Key inclusion criteria (1 listed)
- Patients with MSA-P or PD
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| sweating functionAlso: sweating dysfunction by SudoscanSweating dysfunction by Sudoscan | Procedure or surgery | MSA-P, PD patients |
| Cardiovascular functionCardiovascular (CV) tests | Procedure or surgery | MSA-P, PD patients |
Primary outcome
Sweating autonomic test
Time frame: baseline
Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD
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 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Anne Pavy-Le Traon, MD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorder, run by University Hospital, Toulouse.
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 1 inclusion and 1 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Sweating autonomic test (time frame: baseline). 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 21 Aug 2018.