Evaluation of Emotion-related Salivary Molecular Biomarkers Following Olfactory Stimuli
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Evaluate variations
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
盲法说明
Subjects (participants) do not know which of the two bottles contains the fragrance or the placebo.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bras S Fragrance then placebo
Subjects will be subjected successively to fragrance and placebo stimulation.
干预措施: Identication and measurement of a molecular biomarkers signature (Other)
Bras P Placebo then fragrance
Subjects will be subjected successively to placebo and fragrance stimulation.
干预措施: Identication and measurement of a molecular biomarkers signature (Other)
结局指标
主要结局
Evaluate variations
时间窗: 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).
次要结局
- Evaluate basal values of biomarkers(3 years)
- Identify a molecular biomarker signature(2 years)
- Establish correlations between biomarker signatures and emotion ratings(3 years)
- Compare biomarker signatures(2 years)
- Evaluate signature dynamics(1 year)
研究者
Laurence MOLINA
Project Manager
Sys2Diag