ENOLFEA: Olfactory Training and Emotional State

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT03605524
Collaborator
(none)
240
3
1
59.1
80
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sensory training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Olfactory Training and Emotional State
Actual Study Start Date :
Aug 28, 2018
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Sensory training

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.

Other: Sensory training
12 weeks sensory training
Other Names:
  • Olfactory or visual training
  • Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Olfactory Perception at 3 months [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Score obtained with the Sniffin 'Stick test

    Secondary Outcome Measures

    1. Emotional perception measured Sense'n Feel Method [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Score obtained with Sense'n Feel Method

    2. Emotional perception measured with SMI RED-m Scientific device [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device

    3. Psychometric scale MINI : Psychiatric disorders exploration [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Mini International Neuropsychiatric Interview

    4. Psychometric scale TAS-20 : alexithymia assessment [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Twenty-item toronto Alexithymia Scale (TAS-20)

    5. Psychometric scale STAI-Y : anxiety assessment [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      State Trait Anxiety Inventory

    6. Psychometric scale SHAPS : anhedonia assessment [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      The Snaith-Hamilton Pleasure Scale

    7. Psychometric scale QIDS-SR16 : Depression assessment [Baseline (T0), a month and a half (T1.5), 3 months (T3)]

      Quick Inventory of Depressive Symptomatology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University health service, University ,Tours Tours France 37000
    2 UMR 1253 IBrain, University, Tours Tours France 37032
    3 University Psychiatric Clinic, University hospital,Tours Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    • Study Director: Wissam EL-HAGE, MD-PhD, University Hospital, Tours

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT03605524
    Other Study ID Numbers:
    • PHAO17-WEH/ENOLFEA
    • 2018-A00653-52
    • 2018.05.02
    First Posted:
    Jul 30, 2018
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Tours
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2022