Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects (IDEALE)

San Donato Group (GSD)

Status: Enrolling

Conditions: Cardiac Disease

Treatments: Diagnostic Test: Active standing

Study type: Interventional

Funder types: Other

Identifiers

NCT06785181

394

IDEALE

Details and patient eligibility

About

IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.

To this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age older than 18 years
• spontaneous sinus rhythm
• signed informed consent

Exclusion criteria

• Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system
• Central nervous system disorders
• subjects under drug therapy that may affect the cardiovascular system
• pregnancy
• previous diagnosis of depression

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HEALTHY SUBJECTS

Experimental group

Description:

An experimental setup will be devised for the simultaneous monitoring and recording of EEG, ECG, AP, and R together with CBF in healthy volunteers. The experimental protocol including physiological data recordings includes three sessions lasting 10 minutes each: a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos. The overall duration of the experiment is therefore 30 minutes. A total of 40 short video clips of the duration of 15 seconds each will be presented to a total of 50 voluteers will be recruited for the IDEALE study.

Treatment:

Diagnostic Test: Active standing