Olfactory Training and Emotional State (ENOLFEA)
Primary Purpose
Depressive Symptoms, Depressive Disorder, Major
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sensory training
Sponsored by
About this trial
This is an interventional other trial for Depressive Symptoms focused on measuring Sensory training, Depression, Olfaction, Emotion, Perception
Eligibility Criteria
Inclusion Criteria healthy subjects:
- Without psychiatric history
- QIDS scale score less than or equal to 15
- Affiliation to a social security system
- Able to give his written informed consent
Inclusion Criteria depressed patients:
- With a diagnosis of depressive episode characterized according to the DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI)
- No argument for bipolar disorder or schizophrenia, confirmed by the MINI
- QIDS scale score greater than or equal to 16
- Follow-up in hospitalization and / or ambulatory consultation
- Without comorbidities (alcoholism, eating disorders ...)
- Affiliation to a social security system
- Able to give his written informed consent
Exclusion Criteria healthy subjects and depressed patients:
- Pathology or condition likely to modify their olfactory and / or taste perception
- Allergies with one or more odors, food allergies and / or known anosmias and ageusia
- Legal incapacity and / or circumstances rendering the person incapable of understanding the nature, objectives or consequences of the study
Sites / Locations
- University health service, University ,Tours
- UMR 1253 IBrain, University, ToursRecruiting
- University Psychiatric Clinic, University hospital,ToursRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sensory training
Arm Description
Sensory (Olfactory or visual) training will be done at home for 12 weeks. The effect of the training will be evaluated using an experimental protocol includes (i) clinical and psychometric evaluations, (ii) the study of olfactory perception using Sniffin' Sticks Test and (iii) the study of the emotional perception using the "subjective" Sense'n Feel method and the "objective" measurement of the spontaneous pupillary dilatation.
Outcomes
Primary Outcome Measures
Change from Baseline Olfactory Perception at 3 months
Score obtained with the Sniffin 'Stick test
Secondary Outcome Measures
Emotional perception measured Sense'n Feel Method
Score obtained with Sense'n Feel Method
Emotional perception measured with SMI RED-m Scientific device
Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device
Psychometric scale MINI : Psychiatric disorders exploration
Mini International Neuropsychiatric Interview
Psychometric scale TAS-20 : alexithymia assessment
Twenty-item toronto Alexithymia Scale (TAS-20)
Psychometric scale STAI-Y : anxiety assessment
State Trait Anxiety Inventory
Psychometric scale SHAPS : anhedonia assessment
The Snaith-Hamilton Pleasure Scale
Psychometric scale QIDS-SR16 : Depression assessment
Quick Inventory of Depressive Symptomatology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03605524
Brief Title
Olfactory Training and Emotional State
Acronym
ENOLFEA
Official Title
Olfactory Training and Emotional State
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depressive Disorder, Major
Keywords
Sensory training, Depression, Olfaction, Emotion, Perception
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensory training
Arm Type
Other
Arm Description
Sensory (Olfactory or visual) training will be done at home for 12 weeks.
The effect of the training will be evaluated using an experimental protocol includes (i) clinical and psychometric evaluations, (ii) the study of olfactory perception using Sniffin' Sticks Test and (iii) the study of the emotional perception using the "subjective" Sense'n Feel method and the "objective" measurement of the spontaneous pupillary dilatation.
Intervention Type
Other
Intervention Name(s)
Sensory training
Other Intervention Name(s)
Olfactory or visual training
Intervention Description
12 weeks sensory training
Primary Outcome Measure Information:
Title
Change from Baseline Olfactory Perception at 3 months
Description
Score obtained with the Sniffin 'Stick test
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Outcome Measure Information:
Title
Emotional perception measured Sense'n Feel Method
Description
Score obtained with Sense'n Feel Method
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Emotional perception measured with SMI RED-m Scientific device
Description
Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Psychometric scale MINI : Psychiatric disorders exploration
Description
Mini International Neuropsychiatric Interview
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Psychometric scale TAS-20 : alexithymia assessment
Description
Twenty-item toronto Alexithymia Scale (TAS-20)
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Psychometric scale STAI-Y : anxiety assessment
Description
State Trait Anxiety Inventory
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Psychometric scale SHAPS : anhedonia assessment
Description
The Snaith-Hamilton Pleasure Scale
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Title
Psychometric scale QIDS-SR16 : Depression assessment
Description
Quick Inventory of Depressive Symptomatology
Time Frame
Baseline (T0), a month and a half (T1.5), 3 months (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria healthy subjects:
Without psychiatric history
QIDS scale score less than or equal to 15
Affiliation to a social security system
Able to give his written informed consent
Inclusion Criteria depressed patients:
With a diagnosis of depressive episode characterized according to the DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI)
No argument for bipolar disorder or schizophrenia, confirmed by the MINI
QIDS scale score greater than or equal to 16
Follow-up in hospitalization and / or ambulatory consultation
Without comorbidities (alcoholism, eating disorders ...)
Affiliation to a social security system
Able to give his written informed consent
Exclusion Criteria healthy subjects and depressed patients:
Pathology or condition likely to modify their olfactory and / or taste perception
Allergies with one or more odors, food allergies and / or known anosmias and ageusia
Legal incapacity and / or circumstances rendering the person incapable of understanding the nature, objectives or consequences of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wissam EL-HAGE, MD-PhD
Phone
02.34.37.96.31
Ext
+33
Email
el-hage@med.univ-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Boriana ATANASOVA, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
Organizational Affiliation
University Hospital, Tours
Official's Role
Study Director
Facility Information:
Facility Name
University health service, University ,Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
Facility Name
UMR 1253 IBrain, University, Tours
City
Tours
ZIP/Postal Code
37032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boriana ATANASOVA, PhD
First Name & Middle Initial & Last Name & Degree
Boriana ATANASOVA, PhD
Facility Name
University Psychiatric Clinic, University hospital,Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Wissam EL-HAGE, MD-PhD
12. IPD Sharing Statement
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Olfactory Training and Emotional State
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