Cardiovascular and Cerebrovascular Control in Healthy Sub... | NCT05706532

Studies
Cardiovascular and Cerebrovascular Control in Healthy Subjects

NCT05706532

Sponsor

IRCCS Policlinico S. Donato

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Healthy
Autonomic Nervous System
Cerebral Autoregulation

Interventions

active standing

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2023Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Jan 23, 2023

First Submission Date that Met QC Criteria

Jan 23, 2023

First Posted Date

Jan 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.

To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.

The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		60 healthy subjects; age >18; sinus rhythm; absence of autonomic diseases or dysfunctions.	Diagnostic Test: active standing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
active standing	Diagnostic Test	Data are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing	Healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the state and interactions of autonomic function and cerebrovascular control		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18
sinus rhythm
informed consent signed

Exclusion Criteria:

age <18
presence of autonomic nervous system diseases or dysfunctions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vlasta Bari, PhD	Contact	+390252774381		vlasta.bari@grupposandonato.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Donato	Recruiting	San Donato Milanese	Milan	20097	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided