Characterization of Olfactory Perception in Post-Traumatic Stress Disorder

NCT06494306 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0189
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Post traumatic stress disorder; Olfactory perception; Olfaction; Odor

Outcome Measures

Primary Outcomes (1)

• Standardized Hedonicity Test score

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

  at inclusion

Secondary Outcomes (3)

• Effects of potential moderators on odor judgement

  at inclusion

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

  at inclusion

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

  at inclusion

Study Arms (2)

Patients with PTSD

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

Behavioral: European Test of Olfactory Capabilities (ETOC); Behavioral: Standardized Hedonicity Test; Behavioral: Questionnaires; Behavioral: Odor / trauma association questionnaire

Control group

Data from subjects without PTSD included in a previous study

Behavioral: European Test of Olfactory Capabilities (ETOC); Behavioral: Standardized Hedonicity Test

Interventions

European Test of Olfactory Capabilities (ETOC) BEHAVIORAL

Investigators will collect the ETOC score in patient of both arms

Control group; Patients with PTSD

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))

Control group; Patients with PTSD

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)

Patients with PTSD

Odor / trauma association questionnaire BEHAVIORAL

Patients with PTSD will have Odor / trauma association questionnaire

Patients with PTSD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients aged 18 to 50 suffering from PTSD

You may qualify if:

• Age between 18 to 50
• Subjects with PTSD

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Auvergne-Rhône-Alpes Regional Center for Psychotrauma

Lyon, 69003, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anosmia

Interventions

Surveys and Questionnaires; Odorants

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Environment; Ecological and Environmental Phenomena; Biological Phenomena

Study Officials

• VIGNAUD Philippe, MD, PhD

  Auvergne-Rhône-Alpes Regional Center for Psychotrauma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VIGNAUD Philippe, MD, PhD

CONTACT

+33472116396; philippe.vignaud@chu-lyon.fr

GALIA Perrine, CRA

CONTACT

+33472111311; perrine.galia@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)