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Not yet recruiting NCT06494306

Characterization of Olfactory Perception in Post-Traumatic Stress Disorder

Observational Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: European Test of Olfactory Capabilities (ETOC), Standardized Hedonicity Test, Questionnaires, Odor / trauma association questionnaire.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral European Test of Olfactory Capabilities (ETOC)
    Investigators will collect the ETOC score in patient of both arms
  • 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))
  • 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)
  • Behavioral Odor / trauma association questionnaire
    Patients with PTSD will have Odor / trauma association questionnaire

Primary outcome measures

  • Standardized Hedonicity Test score [Time frame: at inclusion]
Secondary outcome measures (3)
  • Effects of potential moderators on odor judgement [Time frame: at inclusion]
  • Evaluation of sensory impressions of memories evoked by certain odors. [Time frame: at inclusion]
  • Evaluation of emotional valence of memories evoked by certain odors. [Time frame: at inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Auvergne-Rhône-Alpes Regional Center for Psychotrauma — Lyon

Identifiers

NCT: NCT06494306 · 69HCL24_0189

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗