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NCT Number: NCT06494306

Characterization of Olfactory Perception in Post-Traumatic Stress Disorder

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Auvergne-Rhône-Alpes Regional Center for Psychotrauma

Lyon, 69003, France

Location contact

VIGNAUD Philippe, MD, PhD

CONTACT

[email protected]

+33472116396

VIGNAUD Philippe, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

European Test of Olfactory Capabilities (ETOC)

Behavioral

Investigators will collect the ETOC score in patient of both arms

Standardized Hedonicity Test

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

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

Behavioral

Patients with PTSD will have Odor / trauma association questionnaire

Primary outcomes

  1. Standardized Hedonicity Test score

    Time frame: at inclusion

    Results obtained in patients will be compared to those obtained in control group

Secondary outcomes

  1. Effects of potential moderators on odor judgement

    Time frame: at inclusion

    Analysis of covariance (ANCOVA) to determine the effect of different moderators (age, gender, type of trauma, time elapsed since trauma, type of treatment received, symptom intensity) on olfactory perception

  2. Evaluation of sensory impressions of memories evoked by certain odors.

    Time frame: at inclusion

    Sensory impressions: Nature and frequency of sensory descriptions associated with odor-evoked memories

  3. Evaluation of emotional valence of memories evoked by certain odors.

    Time frame: at inclusion

    Language analysis: Use of Natural Language Processing (NLP) techniques to assess the emotional valence of odor-evoked memories and recurrent themes in oral responses concerning evoked memories. Analysis of the association of trauma-related odors with the 5 senses

Study contacts

Contact information is provided by the study sponsor or research team.

GALIA Perrine, CRA

CONTACT

[email protected]

+33472111311

VIGNAUD Philippe, MD, PhD

CONTACT

[email protected]

+33472116396

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TRAUMODO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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