Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids (SensoCort)

September 1, 2023 updated by: Nelly Pitteloud, Centre Hospitalier Universitaire Vaudois

Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations, current methods of cortisol measurement have limitations.

Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in real-time.

The main aim of the study is to compare cortisol levels across biological fluids (sweat, saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and non-invasive cortisol measurement device (currently under development).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Contact:
        • Principal Investigator:
          • Nelly Pitteloud, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy volunteers

Description

Healthy controls:

Inclusion Criteria:

  • age between 18 and 30 years old
  • normal BMI 18 to 25 kg/m2
  • weight stability

Exclusion Criteria:

  • pregnancy, breastfeeding, irregular menses
  • any medical treatment
  • any medical issues
  • pilocarpine allergy, or latex allergy
  • glaucoma or acute irritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)

24 hours sampling of 4 biological fluids:

  • blood: sampling every 20 minutes (through a venous catheter)
  • ISF: automated sampling every 20 minutes (microdialysis technique connected to U-Rhythm device)
  • Sweat : collection of 1 to 3 samples at 4 differents timepoints
  • Saliva : sampling every hour (except during the night)
Other: 24 hours sampling of ISF or sweat (after validating the correlation with blood)
24 hours sampling in an ambulatory setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol levels in 4 biologicals fluids
Time Frame: 24 hours
Comparison of cortisol levels in these 4 biological fluids
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldosterone levels in 4 biological fluids
Time Frame: 24 hours
Comparison of aldosterone levels in these 4 biological fluids
24 hours
Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours
Time Frame: 24 hours

Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)

  • Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of cortisol concentrations (and 18OHF, cortisone) among participants. Amplitude of the curve
  • Pulsatility analysis: frequency of the pulses and amplitude
24 hours
Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours
Time Frame: 24 hours

Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)

  • Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of aldosterone concentrations among participants. Amplitude of the curve
  • Pulsatility analysis: frequency of the pulses and amplitude
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Nelly Pitteloud, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-VD : 2021-01674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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