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Recruiting Not applicable

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

NCT06785181 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-10-03
Last updated
2026-07-06

Condition(s) studied

Cardiac Disease

Investigational drug(s) / intervention(s)

Active standing

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Autoregulation index (ARI) — 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.
  • Baroreflex sensitivity — 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
  • Cortical activity — 36 months
    Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Policlinico San Donato San Donato Milanese Milano Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785181 on ClinicalTrials.gov ↗ ← All trials in Italy