Screening for Alterations in the Autonomic Nervous System

NCT07029191 | Completed

• 2 other identifiers: 49RC25_01642025-A00899-40
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Blood pressure recording

  Day 1

• Heart rate recording

  Day 1

• ACCUVEIN

  Day 1

• Breathing test

  Day 1

Study Arms (1)

Progressive standing test

EXPERIMENTAL

Healthy subjects

Other: Progressive standing test

Interventions

Progressive standing test OTHER

Progressive raising test in successive steps in a healthy subject

Progressive standing test

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University hospital

Angers, France

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: November 21, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)