NCT05706532

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started May 2023

Longer than P75 for all trials

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 Progress68%
May 2023Oct 2027

First Submitted

Initial submission to the registry

January 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

January 23, 2023

Last Update Submit

March 25, 2025

Conditions

HealthyAutonomic Nervous SystemCerebral Autoregulation

Keywords

autonomic nervous systemheart rate variabilitycerebral autoregulationperipheral resistances

Outcome Measures

Primary Outcomes (1)

  • Evaluate the state and interactions of autonomic function and cerebrovascular control

    12 months

Study Arms (1)

Healthy

60 healthy subjects; age \>18; sinus rhythm; absence of autonomic diseases or dysfunctions.

Diagnostic Test: active standing

Interventions

active standingDIAGNOSTIC_TEST

Data are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing

Healthy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects

You may qualify if:

  • age \>18
  • sinus rhythm
  • informed consent signed

You may not qualify if:

  • age \<18
  • presence of autonomic nervous system diseases or dysfunctions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Central Study Contacts

Vlasta Bari, PhD

CONTACT

+390252774381vlasta.bari@grupposandonato.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 31, 2023

Study Start

May 29, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)