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

July 2, 2026 updated by: Vlasta Bari, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy, 20097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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
Other Names:
  • Emotional tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autoregulation index (ARI)
Time Frame: 36 months
ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. Minimum value 0, maximum value 9. ARI>4 means working autoregulation. ARI<4 means impaired autoregulation. It will be computed for all participants.
36 months
Baroreflex sensitivity
Time Frame: 36 months
Baroreflex sensitivity will be measured in ms/mmHg. Minimum value 0. Higher value means a better baroreflex regulation. It will be computed in all participants
36 months
Cortical activity
Time Frame: 36 months
Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

October 3, 2027

Study Completion (Estimated)

October 3, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDEALE
  • 394 (Other Identifier: IRCCS Policlinico San Donato)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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