NCT06785181

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Oct 2024Oct 2027

Study Start

First participant enrolled

October 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2027

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

November 4, 2024

Last Update Submit

March 25, 2025

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (3)

  • Autoregulation index (ARI)

    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

    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

    Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.

    36 months

Study Arms (1)

HEALTHY SUBJECTS

EXPERIMENTAL

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

Interventions

Active standingDIAGNOSTIC_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

Also known as: Emotional tests
HEALTHY SUBJECTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Vlasta Bari, PhD

CONTACT

+390252774381vlasta.bari@grupposandonato.it

Pavandeep Singh

CONTACT

+390252774381pavandeep.singh@grupposandonato.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Bioengineeering

Study Record Dates

First Submitted

November 4, 2024

First Posted

January 21, 2025

Study Start

October 3, 2024

Primary Completion (Estimated)

October 3, 2027

Study Completion (Estimated)

October 3, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)