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NCT Number: NCT06785181

Dynamic Cardio-vascular, 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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location status: Recruiting

Location contact

Vlasta Bari, PhD

CONTACT

[email protected]

39 02 5277 4381

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active standing

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

Other names: Emotional tests

Primary outcomes

  1. 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.

  2. 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

  3. Cortical activity

    Time frame: 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pavandeep Singh

CONTACT

[email protected]

+390252774381

Vlasta Bari, PhD

CONTACT

[email protected]

+390252774381

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Acronym: IDEALE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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