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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

age older than 18 years

spontaneous sinus rhythm

signed informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: HEALTHY SUBJECTSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months
2

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

Time frame
36 months
3

Cortical activity

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

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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