Olfactory Training and Emotional State
ENOLFEA
3 other identifiers
interventional
150
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2023
CompletedDecember 30, 2025
December 1, 2025
4.8 years
July 12, 2018
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Olfactory Perception at 3 months
Score obtained with the Sniffin 'Stick test
Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Outcomes (7)
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)
- +2 more secondary outcomes
Study Arms (1)
Sensory training
OTHERSensory (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.
Interventions
12 weeks sensory training
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University health service, University ,Tours
Tours, 37000, France
UMR 1253 IBrain, University, Tours
Tours, 37032, France
University Psychiatric Clinic, University hospital,Tours
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wissam EL-HAGE, MD-PhD
University Hospital, Tours
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2018
First Posted
July 30, 2018
Study Start
August 28, 2018
Primary Completion
June 27, 2023
Study Completion
June 27, 2023
Last Updated
December 30, 2025
Record last verified: 2025-12