Screening for Alterations in the Autonomic Nervous System

NCT ID: NCT07029191

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-21
• Study Completion Date: 2025-12-12

Brief 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. 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Progressive standing test

Healthy subjects

Group Type: EXPERIMENTAL

Progressive standing test

Intervention Type: OTHER

Progressive raising test in successive steps in a healthy subject

Interventions

Progressive standing test

Progressive raising test in successive steps in a healthy subject

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angers University hospital

Angers, , France

Countries

France

Other Identifiers

2025-A00899-40

Identifier Type: OTHER

Identifier Source: secondary_id

49RC25_0164

Identifier Type: -

Identifier Source: org_study_id