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

NCT ID: NCT06785181

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-03

Study Completion Date

2027-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HEALTHY SUBJECTS

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.

Group Type EXPERIMENTAL

Active standing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Active standing

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Emotional tests

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Vlasta Bari

Associate Professor in Bioengineeering

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vlasta Bari, PhD

Role: CONTACT

+390252774381

Pavandeep Singh

Role: CONTACT

+390252774381

Facility Contacts

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Vlasta Bari, PhD

Role: primary

39 02 5277 4381

Other Identifiers

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394

Identifier Type: OTHER

Identifier Source: secondary_id

IDEALE

Identifier Type: -

Identifier Source: org_study_id

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