Adrenal InsufficiencySensoCortNCT06008184
Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
An observational study of Adrenal Insufficiency and Cushing Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism
- What is being tested?
- 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva) and 24 hours sampling of ISF or sweat (after validating the correlation with blood)
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2021to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- age between 18 and 30 years old
- normal BMI 18 to 25 kg/m2
- weight stability
Who cannot join
- pregnancy, breastfeeding, irregular menses
- any medical treatment
- any medical issues
- pilocarpine allergy, or latex allergy
- glaucoma or acute irritis
Trial locations and contacts
1 site in 1 country.
Nathalie Vionnet, MD-PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
Adelina Ameti, +41 79 556 68 30, adelina.ameti@chuv.ch
Emmanuelle Paccou, +41 79 556 60 13, emmanuelle.paccou@chuv.ch
About this study
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
- Being tested
- 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva), 24 hours sampling of ISF or sweat (after validating the correlation with blood)
- Medical subject headings
- Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)Other
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 of ISF or sweat (after validating the correlation with blood)Other
24 hours sampling in an ambulatory setting
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol levels in 4 biologicals fluids
Comparison of cortisol levels in these 4 biological fluids
Measured: 24 hours
Secondary outcomes (3)
Aldosterone levels in 4 biological fluids
Comparison of aldosterone levels in these 4 biological fluids
Measured: 24 hours
Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 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
Measured: 24 hours
Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Sep 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly Pitteloud, Centre Hospitalier Universitaire Vaudois
- Investigators
- Nelly Pitteloud, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008184
- Sponsor's protocol ID
- CER-VD : 2021-01674
- Acronym
- SensoCort
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
- ClinicalTrials.gov ID
- NCT06008184
- Acronym / sponsor ID
- SensoCort / CER-VD : 2021-01674
- Conditions
- Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- age between 18 and 30 years old
- normal BMI 18 to 25 kg/m2
- weight stability
Key exclusion criteria (5 listed)
- pregnancy, breastfeeding, irregular menses
- any medical treatment
- any medical issues
- pilocarpine allergy, or latex allergy
- glaucoma or acute irritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Healthy controls |
| 24 hours sampling of ISF or sweat (after validating the correlation with blood)24 hours sampling in an ambulatory setting | Other | Healthy controls |
Primary outcome
Cortisol levels in 4 biologicals fluids
Time frame: 24 hours
Comparison of cortisol levels in these 4 biological fluids
3 secondary outcomes
Aldosterone levels in 4 biological fluids
Time frame: 24 hours
Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours
Time frame: 24 hours
Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Vionnet, MD-PhD contact
Nelly Pitteloud, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency and Cushing Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adelina Ameti (0041795568630, adelina.ameti@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol levels in 4 biologicals fluids (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.