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临床试验/NCT03605524
NCT03605524已完成不适用

Olfactory Training and Emotional State

University Hospital, Tours6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
6
主要终点
Change from Baseline Olfactory Perception at 3 months

研究概览

简要总结

During the past three decades, researchers have paid particular attention to the study of olfactory disorders in depression. Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks.

From all these observations, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.

详细描述

Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks. Therefore, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.

The main objective is to study the effect of daily olfactory training on the emotional state and emotional perception of the subject. The effect of the training will be evaluated using three types of evaluations: (1) a clinical evaluation and the psychometric scales, (2) the investigation of the olfactory function and (3) the study of the emotional perception.

The secondary objectives are:

  • The identification of olfactory parameters and emotional valences associated with minor depressive symptoms.
  • The study of the link between the subjective and objective emotional response on the one hand, and the link between olfactory function, emotional perception and emotional state on the other hand in depressed patients and in individuals with minor depressive symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from Baseline Olfactory Perception at 3 months

时间窗: Baseline (T0), a month and a half (T1.5), 3 months (T3)

Score obtained with the Sniffin 'Stick test

次要结局

  • Emotional perception measured Sense'n Feel Method(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Emotional perception measured with SMI RED-m Scientific device(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Psychometric scale MINI : Psychiatric disorders exploration(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Psychometric scale TAS-20 : alexithymia assessment(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Psychometric scale STAI-Y : anxiety assessment(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Psychometric scale SHAPS : anhedonia assessment(Baseline (T0), a month and a half (T1.5), 3 months (T3))
  • Psychometric scale QIDS-SR16 : Depression assessment(Baseline (T0), a month and a half (T1.5), 3 months (T3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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