NCT06008184

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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).

Conditions

• Adrenal Insufficiency
• Cushing Syndrome
• Hyperaldosteronism

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-08-23
• Last updated: 2023-09-06

Locations

1 site across 1 country: Switzerland