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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00899-40 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive standing test | Experimental | Healthy subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive standing test | Other | Progressive raising test in successive steps in a healthy subject |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Heart rate recording |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University hospital | Angers | France |
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| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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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.
| 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. | 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. | Day 1 |