NCT05358314

Brief Summary

This study seeks to investigate which regions of the brain are relevant in the regulation of cardiac control and how the interplay between HRV and those regions change during different physiological states (stress versus relaxation). In order to achieve this, we will use functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress task (Montreal Imaging Stress Task).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

March 28, 2022

Last Update Submit

November 28, 2023

Conditions

Heart RateMagnetic Resonance ImagingStress, Physiological

Keywords

fmriheart rate variability

Outcome Measures

Primary Outcomes (2)

  • Experimental fMRI task (Stress induction following paced breathing)

    Participants are instructed to breathe at a very low pace and then have to complete an arithmethic task designed to induce stress.

    30 minutes

  • HRV reactivity during stress

    Heart Rate Variability is assessed during MRI scanning using plethysmography.

    30 minutes

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants

You may qualify if:

  • Over age of 18 years.
  • Right-handedness.
  • Normal or corrected-to-normal vision.

You may not qualify if:

  • History of head injury or surgery
  • History of neurological disorder
  • Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
  • Smoking
  • Borderline personality disorder
  • Current psychotropic medication
  • Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 3, 2022

Study Start

February 1, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)