Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
SensoCort
1 other identifier
observational
12
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Typical duration for all trials
1 active site
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 Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedSeptember 6, 2023
September 1, 2023
3 years
August 18, 2023
September 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cortisol levels in 4 biologicals fluids
Comparison of cortisol levels in these 4 biological fluids
24 hours
Secondary Outcomes (3)
Aldosterone levels in 4 biological fluids
24 hours
Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours
24 hours
Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours
24 hours
Study Arms (1)
Healthy controls
Interventions
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)
24 hours sampling in an ambulatory setting
Eligibility Criteria
Healthy volunteers
You may qualify if:
- age between 18 and 30 years old
- normal BMI 18 to 25 kg/m2
- weight stability
You may not qualify if:
- pregnancy, breastfeeding, irregular menses
- any medical treatment
- any medical issues
- pilocarpine allergy, or latex allergy
- glaucoma or acute irritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nelly Pitteloud, MD
Centre Hospitalier Universitaire Vaudois
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 18, 2023
First Posted
August 23, 2023
Study Start
September 1, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
September 6, 2023
Record last verified: 2023-09