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

Vaud University Hospital Center

Status: Enrolling

Conditions: Adrenal Insufficiency; Hyperaldosteronism; Cushing Syndrome

Treatments: 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 type: Observational

Funder types: Other

Identifiers

NCT06008184

CER-VD : 2021-01674

Details and patient eligibility

About

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).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

12 participants in 1 patient group

Healthy controls

Treatment:

Other: 24 hours sampling of ISF or sweat (after validating the correlation with blood)

Other: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)