DysautonomiaSYMPA-VEINNCT07029191
Screening for Alterations in the Autonomic Nervous System
A study testing Progressive standing test in people with Dysautonomia and ACCUVEIN, run by University Hospital, Angers at 1 site in France.
Trial summary
Dysautonomia is an alteration of the autonomic nervous system that manifests itself in different forms, some of which are very disabling. Dysautonomia accompanies many pathologies. Its importance in public health is illustrated by an incidence of 20-70% in diabetes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysautonomia, ACCUVEIN, Superficial Veins
- What is being tested?
- Progressive standing test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2025to 12 Dec 2025
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between the ages of 18 and 40
- Subject affiliated with or benefiting from a social security plan
- Subject having signed an informed consent form
- Subject without known chronic illness or long-term treatment (oral contraceptive authorized for women)
- Subject without symptoms of dysautonomia
- Subject with no history of cardiovascular disease
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- No history of loss of consciousness
- Subjects without regular and excessive alcohol consumption according to the WHO
- Non-smoker, non-vapoteur
- No chronic pain
Who cannot join
- Known ECG abnormality
- Pregnant women, parturients and nursing mothers
- Person deprived of liberty by administrative or judicial decision
- Person under compulsory psychiatric care
- Adult subject to a legal protection measure
- Persons unable to express their consent
- Subject unable to understand study objectives or instructions
- Subject in a period of exclusion from another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SYMPA-VEIN : Pilot Study Evaluating the ACCUVEIN Superficial Vein Visualization Device for the Detection of Alterations in the Autonomic Nervous System
Dysautonomia is an alteration of the autonomic nervous system that manifests itself in different forms, some of which are very disabling. Dysautonomia accompanies many pathologies. Its importance in public health is illustrated by an incidence of 20-70% in diabetes. It affects between 400,000 and 1.4 million patients in the French diabetic population alone. Dysautonomia is mainly investigated through alterations in the cardiovascular system's reactivity to various maneuvers. It involves a methodology that evaluates the functionality of the sympathetic nervous system. This methodology is reserved for specialized laboratories, limiting access to diagnosis. Dysautonomia is therefore commonly overlooked for lack of a simple, effective diagnostic tool.
ACCUVEIN is an augmented-reality venipuncture device. It projects the network of superficial veins onto the patient's skin. Our aim is to show that ACCUVEIN is capable of objectivizing the venoconstriction caused by activation of the sympathetic system in a healthy subject, such as when moving to a standing position. If ACCUVEIN has this capability, it would then represent a simple and rapid diagnostic tool for objectifying a venoconstriction defect in patients with dysautonomia.
- Being tested
- Progressive standing test
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive standing testOther
Progressive raising test in successive steps in a healthy subject
| Study group | Role | What they receive |
|---|---|---|
| Progressive standing test | Experimental | Healthy subjects Receives: Other: Progressive standing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive standing test
If the subject's resting ECG is normal, the experimental session then begins with a progressive uprighting test of the subject in increments starting at 0° (the horizontal position) then moving on to 15°, then 30°, then 45° and finally 70°, the maximum upright head-up position, i.e. a total of 5 increments). Progressive verticalization is performed on a verticalization table used in standard autonomic nervous system assessment procedures. Three thoracic electrocardiographic electrodes and the blood pressure measurement finger pad on the right middle finger are positioned, then the left upper limb is stripped and held at heart level by a suitable support throughout the experimental procedure. The subject then lies down on the examination table. Each level is maintained for 5 minutes. At the end of the last 70° stop, the examination table is returned to the horizontal position.
Measured: Day 1
Secondary outcomes (4)
Blood pressure recording
Recording of blood pressure by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.
Measured: Day 1
Heart rate recording
Heart rate recording by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.
Measured: Day 1
ACCUVEIN
A photograph of the forearm, with the superficial veins highlighted by the ACCUVEIN device, is taken during the last minute of each stage.
Measured: Day 1
Breathing test
To confirm the absence of dysautonomia, two very short tests are performed. These tests involve asking the subject to breathe according to the experimenter's instructions (inflate lungs, deflate lungs), who then imposes a normal breathing rhythm of 12 cycles per minute for one minute. The subject is then asked to stand up on his own and maintain this posture for 30 seconds.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start21 Nov 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysautonomiaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029191
- Sponsor's protocol ID
- 49RC25_0164
- Other IDs
- 2025-A00899-40
- Acronym
- SYMPA-VEIN
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2025
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYMPA-VEIN : Pilot Study Evaluating the ACCUVEIN Superficial Vein Visualization Device for the Detection of Alterations in the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT07029191
- Acronym / sponsor ID
- SYMPA-VEIN / 49RC25_0164
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 Jun 2025 (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.
Dysautonomia is an alteration of the autonomic nervous system that manifests itself in different forms, some of which are very disabling. Dysautonomia accompanies many pathologies. Its importance in public health is illustrated by an incidence of 20-70% in diabetes. It affects between 400,000 and 1.4 million patients in the French diabetic population alone. Dysautonomia is mainly investigated through alterations in the cardiovascular system's reactivity to various maneuvers. It involves a methodology that evaluates the functionality of the sympathetic nervous system. This methodology is reserved for specialized laboratories, limiting access to diagnosis. Dysautonomia is therefore commonly overlooked for lack of a simple, effective diagnostic tool.
ACCUVEIN is an augmented-reality venipuncture device. It projects the network of superficial veins onto the patient's skin. Our aim is to show that ACCUVEIN is capable of objectivizing the venoconstriction caused by activation of the sympathetic system in a healthy subject, such as when moving to a standing position. If ACCUVEIN has this capability, it would then represent a simple and rapid diagnostic tool for objectifying a venoconstriction defect in patients with dysautonomia.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progressive standing test | Experimental | Other: Progressive standing testHealthy subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects between the ages of 18 and 40
- Subject affiliated with or benefiting from a social security plan
- Subject having signed an informed consent form
- Subject without known chronic illness or long-term treatment (oral contraceptive authorized for women)
- Subject without symptoms of dysautonomia
Key exclusion criteria (8 listed)
- Known ECG abnormality
- Pregnant women, parturients and nursing mothers
- Person deprived of liberty by administrative or judicial decision
- Person under compulsory psychiatric care
- Adult subject to a legal protection measure
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 |
|---|---|---|
| Progressive standing testProgressive raising test in successive steps in a healthy subject | Other | Progressive standing test |
Primary outcome
Progressive standing test
Time frame: Day 1
If the subject's resting ECG is normal, the experimental session then begins with a progressive uprighting test of the subject in increments starting at 0° (the horizontal position) then moving on to 15°, then 30°, then 45° and finally 70°, the maximum upright head-up position, i.e. a total of 5 increments). Progressive verticalization is performed on a verticalization table used in standard autonomic nervous system assessment procedures. Three thoracic electrocardiographic electrodes and the blood pressure measurement finger pad on the right middle finger are positioned, then the left upper limb is stripped and held at heart level by a suitable support throughout the experimental procedure. The subject then lies down on the examination table. Each level is maintained for 5 minutes. At the end of the last 70° stop, the examination table is returned to the horizontal position.
4 secondary outcomes
Blood pressure recording
Time frame: Day 1
Heart rate recording
Time frame: Day 1
ACCUVEIN
Time frame: Day 1
Breathing test
Time frame: Day 1
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 24 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive standing test in people with Dysautonomia and ACCUVEIN, run by University Hospital, Angers at 1 site in France.
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 10 inclusion and 8 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 24 Dec 2025. 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 France. 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?
Progressive standing test (time frame: Day 1). 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 24 Dec 2025.