- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320040
Evaluation of Emotion-related Salivary Molecular Biomarkers (EMJOY)
Evaluation of Emotion-related Salivary Molecular Biomarkers Following Olfactory Stimuli
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent studies show that emotional states (positive and negative) can be discriminated by physiological responses. This physiological regulation stems from the action of enzymes and hormones that represent the activity of the autonomic nervous system. The measurement of specific biomarkers (enzymes, hormones), using non-invasive biological tests in saliva, would therefore provide physiological data on an individual's emotional state (Giacomello et al. 2020) in response to stimuli, particularly olfactory stimuli.
The aim of the proposed research is to identify and measure a signature of molecular biomarkers in saliva, linked to emotions following one or more olfactory stimuli (e.g. cortisol and alpha-amylase concentration increase after stimulation).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wendpouiré A OUEDRAOGO, Msc
- Phone Number: +33 (0) 467 047 481
- Email: alimata.ouedraogo@sys2diag.cnrs.fr
Study Locations
-
-
-
Montpellier, France
- Recruiting
- SYS2DIAG - UMR9005 CNRS/ALCEN, Montpellier, 34184
-
Contact:
- Franck MOLINA, Phd
- Phone Number: +33 (0) 467 047 460
- Email: s2d.cpp@sys2diag.cnrs.fr
-
Contact:
- Wendpouiré A OUEDRAOGO, Msc
- Phone Number: +33 (0) 467 047 481
- Email: s2d.cpp@sys2diag.cnrs.fr
-
Principal Investigator:
- Laurence MOLINA, PhD
-
Sub-Investigator:
- Francisco SANTOS SCHNEIDER, Phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject willing to follow study procedures
- Subject able to understand the purpose, nature and methodology of the study
- Subject has signed informed consent form
- Subjects between 18 and 60 years of age.
Exclusion Criteria:
- Subjects deprived of liberty, protected adults, vulnerable persons or minors
- Subjects with a proven or suspected chronic infectious disease that could entail a risk of contamination during sample handling (laboratories not equipped to handle this type of sample)
- Rejection to sign the consent form.
Non specific inclusion criteria:
- Pregnant or breastfeeding women
- Subjects presenting anosmia during the last 15 days
- Subjects presenting symptoms and signs of active oral inflammation, advanced periodontitis or severe gingivitis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bras S Fragrance then placebo
Subjects will be subjected successively to fragrance and placebo stimulation.
|
Levels of the biomarkers of interest (DHEA, pg/mL; Oxytocin, pg/mL; Cortisol, pg/mL; Alpha Amylase, U/mL) will be measured in the saliva of participating subjects by enzymatic assay methods or ELISA-type methods performed using commercial kits.
|
|
Bras P Placebo then fragrance
Subjects will be subjected successively to placebo and fragrance stimulation.
|
Levels of the biomarkers of interest (DHEA, pg/mL; Oxytocin, pg/mL; Cortisol, pg/mL; Alpha Amylase, U/mL) will be measured in the saliva of participating subjects by enzymatic assay methods or ELISA-type methods performed using commercial kits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate variations
Time Frame: 1 year
|
Evaluate variations in several molecular biomarkers in saliva following fragrance stimulus/stimuli that may be linked to an emotionnal response (positive or negative).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify a molecular biomarker signature
Time Frame: 2 years
|
Identify a molecular biomarker signature in saliva following fragrance stimulus or stimuli.
|
2 years
|
|
Evaluate basal values of biomarkers
Time Frame: 3 years
|
Evaluate basal values of biomarkers composing the signature under normal, unstimulated conditions (intra-individual, inter-individual variations, circadian rhythm, age, gender...).
|
3 years
|
|
Establish correlations between biomarker signatures and emotion ratings
Time Frame: 3 years
|
Establish correlations between biomarker signatures and emotion ratings based on other criteria, such as questionnaires.
|
3 years
|
|
Compare biomarker signatures
Time Frame: 2 years
|
Compare biomarker signatures in response to different fragrance stimuli.
|
2 years
|
|
Evaluate signature dynamics
Time Frame: 1 year
|
Evaluate signature dynamics after stimulation
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurence MOLINA, PhD, Sys2Diag
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-A02008-35
- 22.03698.000189 (Other Identifier: Comité de protection des personnes (French Ethics committee))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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