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Completed

NCT Number: NCT07029191

Screening for 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.

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Key information

Conditions

Dysautonomia ACCUVEIN Autonomic Nervous System Diseases Nervous System Diseases Standing Test Superficial Veins Sympathetic Nervous System

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University hospital

Angers, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No history of loss of consciousness
  • Subjects without regular and excessive alcohol consumption according to the WHO
  • Non-smoker, non-vapoteur
  • No chronic pain

Exclusion criteria

  • 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

Treatment and study plan

Progressive standing test

Other

Progressive raising test in successive steps in a healthy subject

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood pressure recording

    Time frame: Day 1

    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.

  2. Heart rate recording

    Time frame: Day 1

    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.

  3. ACCUVEIN

    Time frame: Day 1

    A photograph of the forearm, with the superficial veins highlighted by the ACCUVEIN device, is taken during the last minute of each stage.

  4. Breathing test

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

SYMPA-VEIN : Pilot Study Evaluating the ACCUVEIN Superficial Vein Visualization Device for the Detection of Alterations in the Autonomic Nervous System

Acronym: SYMPA-VEIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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