Characterization of Olfactory Perception in Post-Traumatic Stress Disorder

NCT ID: NCT06494306

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-26

Study Completion Date

2026-08-25

Brief Summary

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The core symptoms of post-traumatic stress disorder (PTSD) include flash backs, intrusive pictures and thoughts related to the traumatic event, hyperalertness, avoidance of traumatic relevant environmental triggers and emotional dysregulation. Some studies suggest that PTSD is also associated with impaired olfactory perception, which seems quite intuitive regarding the close anatomical-functional connections between olfactory and emotional circuits. Furthermore, some studies reported that olfactory stimuli can trigger flashbacks in subjects with PTSD. However, up to know available data is scarce and heterogeneous concerning that topic. The goal of the study is to determine the olfactory phenotype of subjects with PTSD. More precisely, this project aims at filling the above mentioned gap by systematically assessing the olfactory perception of subjects with PTSD along five dimensions: olfactory identity, hedonic value, familiarity, desirability and edibility. As a secondary goal, the relative weight of olfaction compared to the other senses in the relived memories of subjects with PTSD will be assessed.

The investigators here hypothesize a global impairment in olfactory processing (intensity, hedonicity, familiarity and edibility judgments) in PTSD subjects, compared with healthy subjects.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PTSD

They are outpatients receiving psychological and medical treatment in the clinical department connected to the inclusion site

European Test of Olfactory Capabilities (ETOC)

Intervention Type BEHAVIORAL

Investigators will collect the ETOC score in patient of both arms

Standardized Hedonicity Test

Intervention Type BEHAVIORAL

To smell 20 odorant solutions and for each odor and evaluate it along five dimensions: familiarity, hedonicity, edibility, desire to smell again, perceived intensity). Each dimension is assessed with a Likert scale (from 1 (not at all) to 9 (extremely))

Questionnaires

Intervention Type BEHAVIORAL

Patients with PTSD will have the following questionnaires : PTSD Checklist for Diagnostic and Statistical Manual (DSM)-V (PCL-5), Peri-trauma Dissociation Experience Questionnaire (PDEQ), Patient Health Questionnaire-9 (PHQ9), Snaith-Hamilton Pleasure Scale (SHAPS), Childhood Trauma Questionnaire (CTQ) and Apathy Evaluation Scale (AES)

Odor / trauma association questionnaire

Intervention Type BEHAVIORAL

Patients with PTSD will have Odor / trauma association questionnaire

Control group

Data from subjects without PTSD included in a previous study

European Test of Olfactory Capabilities (ETOC)

Intervention Type BEHAVIORAL

Investigators will collect the ETOC score in patient of both arms

Standardized Hedonicity Test

Intervention Type BEHAVIORAL

To smell 20 odorant solutions and for each odor and evaluate it along five dimensions: familiarity, hedonicity, edibility, desire to smell again, perceived intensity). Each dimension is assessed with a Likert scale (from 1 (not at all) to 9 (extremely))

Interventions

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European Test of Olfactory Capabilities (ETOC)

Investigators will collect the ETOC score in patient of both arms

Intervention Type BEHAVIORAL

Standardized Hedonicity Test

To smell 20 odorant solutions and for each odor and evaluate it along five dimensions: familiarity, hedonicity, edibility, desire to smell again, perceived intensity). Each dimension is assessed with a Likert scale (from 1 (not at all) to 9 (extremely))

Intervention Type BEHAVIORAL

Questionnaires

Patients with PTSD will have the following questionnaires : PTSD Checklist for Diagnostic and Statistical Manual (DSM)-V (PCL-5), Peri-trauma Dissociation Experience Questionnaire (PDEQ), Patient Health Questionnaire-9 (PHQ9), Snaith-Hamilton Pleasure Scale (SHAPS), Childhood Trauma Questionnaire (CTQ) and Apathy Evaluation Scale (AES)

Intervention Type BEHAVIORAL

Odor / trauma association questionnaire

Patients with PTSD will have Odor / trauma association questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 18 to 50
* Subjects with PTSD

Exclusion Criteria

* Patients with a neurological history such as stroke, head trauma (e.g. exposure to explosions, sports injury…), neurodegenerative disease…
* Any psychiatric condition except PTSD and major depressive disorder
* Current or recent use of psychotropic drugs that may affect olfactory function.
* Any current or remitted addictive disorder.
* Pregnancy and breast-feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VIGNAUD Philippe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Auvergne-Rhône-Alpes Regional Center for Psychotrauma

Locations

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Auvergne-Rhône-Alpes Regional Center for Psychotrauma

Lyon, , France

Site Status

Countries

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France

Central Contacts

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VIGNAUD Philippe, MD, PhD

Role: CONTACT

+33472116396

GALIA Perrine, CRA

Role: CONTACT

+33472111311

Facility Contacts

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VIGNAUD Philippe, MD, PhD

Role: primary

+33472116396

Other Identifiers

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69HCL24_0189

Identifier Type: -

Identifier Source: org_study_id

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