Evaluation of Emotion-related Salivary Molecular Biomarkers

Официальное название

Evaluation of Emotion-related Salivary Molecular Biomarkers Following Olfactory Stimuli

Обзор

Recent studies show that emotional states can be discriminated by physiological responses. This physiological regulation results from the action of enzymes and hormones that represent the activity of the autonomic nervous system. The measurement of specific biomarkers, using non-invasive biological tests in saliva, would therefore provide physiological data on an individual's emotional state in response to stimuli, particularly olfactory stimuli.

Подробное описание

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).

Вмешательства

• Другое Identication and measurement of a molecular biomarkers signature
  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.

Первичные конечные точки

• Evaluate variations [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Identify a molecular biomarker signature [Срок оценки: 2 years]
• Evaluate basal values of biomarkers [Срок оценки: 3 years]
• Evaluate signature dynamics [Срок оценки: 1 year]
• Establish correlations between biomarker signatures and emotion ratings [Срок оценки: 3 years]
• Compare biomarker signatures [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• SYS2DIAG - UMR9005 CNRS/ALCEN, Montpellier, 34184 — Montpellier

Публикации

• Giacomello G, Scholten A, Parr MK. Current methods for stress marker detection in saliva. J Pharm Biomed Anal. 2020 Nov 30;191:113604. doi: 10.1016/j.jpba.2020.113604. Epub 2020 Sep 6. PMID 32957066

Идентификаторы

NCT: NCT07320040 · 2022-A02008-35 · 22.03698.000189

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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