NCT05760872

Brief Summary

Influence of placing the esophageal probe on the cortisol response. Number of cortisol (non)responders and association of heart rate and subjective perception of stress with cortisol levels.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 20, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

October 20, 2021

Last Update Submit

March 6, 2023

Conditions

Cortisol

Outcome Measures

Primary Outcomes (1)

  • cortisol levels

    Change in cortisol levels

    every 15 minutes a saliva sample during 4.5 hours: at time points (in minutes) 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270

Secondary Outcomes (1)

  • cortisol responders

    up to 4 hours of cortisol measurement

Study Arms (1)

Placement of an esophageal catheter

In this group we will assess the influence of placing an esophageal catheter on the cortisol levels in HV

Other: Placing esophageal probe

Interventions

Placing esophageal probeOTHER

Placing an esophageal probe through the mouth

Placement of an esophageal catheter

Eligibility Criteria

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

Healthy volunteers with no or less experience with placing an esophageal probe

You may qualify if:

  • Aged between 18 to 65 years. All participants will receive and sign a copy of the informed consent before initiation of the study.

You may not qualify if:

  • A history of any upper gastrointestinal (GI) symptoms, complaints or diseases;
  • Prior history of esophageal or gastric surgery or endoscopic anti-reflux procedure;
  • Psychiatric disorders;
  • Concomitant use of other medication or treatments except for oral contraceptives;
  • Use of medication altering GI motility;
  • Pregnant or nursing women;
  • History of drugs or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TARGID

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Central Study Contacts

Annelies Geeraerts

CONTACT

+321643385annelies.geeraerts@kuleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 20, 2021

First Posted

March 8, 2023

Study Start

November 4, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

BE(1)