Screening for Alterations in the Autonomic Nervous System (SYMPA-VEIN)

University Hospital, Angers

Status: Completed

Conditions: Sympathetic Nervous System; ACCUVEIN; Superficial Veins; Dysautonomia; Standing Test

Treatments: Other: Progressive standing test

Study type: Interventional

Funder types: Other

Identifiers

NCT07029191

49RC25_0164

2025-A00899-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Progressive standing test

Experimental group

Description:

Healthy subjects

Treatment:

Other: Progressive standing test