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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Recruiting

CT.gov ID

NCT06008184

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Adrenal Insufficiency Cushing Syndrome Hyperaldosteronism	Other: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva) Other: 24 hours sampling of ISF or sweat (after validating the correlation with blood)

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Cortisol levels in 4 biologicals fluids [24 hours]
Comparison of cortisol levels in these 4 biological fluids

Secondary Outcome Measures

Aldosterone levels in 4 biological fluids [24 hours]
Comparison of aldosterone levels in these 4 biological fluids
Glucocorticoid - diurnal rhythm and pulsatility [24 hours]
Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)
Mineralocorticoid - diurnal rhythm and pulsatility [24 hours]
Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud	Switzerland	1005

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nelly Pitteloud, Professor, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT06008184

Other Study ID Numbers:

CER-VD : 2021-01674

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adrenal Insufficiency

Cushing Syndrome

Hyperaldosteronism

Study Results

No Results Posted as of Aug 23, 2023