Post Traumatic Stress DisorderTRAUMODONCT06494306
Characterization of Olfactory Perception in Post-Traumatic Stress Disorder
An observational study of Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- European Test of Olfactory Capabilities (ETOC), Standardized Hedonicity Test and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2024to 25 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients aged 18 to 50 suffering from PTSD
Who may be able to join
- Age between 18 to 50
- Subjects with PTSD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Auvergne-Rhône-Alpes Regional Center for Psychotrauma
Lyon, 69003
VIGNAUD Philippe, MD, PhD, +33472116396, philippe.vignaud@chu-lyon.fr
VIGNAUD Philippe, MD, PhD
About this study
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
- Being tested
- European Test of Olfactory Capabilities (ETOC), Standardized Hedonicity Test, Questionnaires, Odor / trauma association questionnaire
- Keywords
- Post traumatic stress disorder, Olfactory perception, Olfaction, Odor
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Test of Olfactory Capabilities (ETOC)Behavioural
Investigators will collect the ETOC score in patient of both arms
Standardized Hedonicity TestBehavioural
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))
QuestionnairesBehavioural
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 questionnaireBehavioural
Patients with PTSD will have Odor / trauma association questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with PTSD | They are outpatients receiving psychological and medical treatment in the clinical department connected to the inclusion site Receives: 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 Receives: Behavioral: European Test of Olfactory Capabilities (ETOC); Behavioral: Standardized Hedonicity Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Hedonicity Test score
Results obtained in patients will be compared to those obtained in control group
Measured: at inclusion
Secondary outcomes (3)
Effects of potential moderators on odor judgement
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
Measured: at inclusion
Evaluation of sensory impressions of memories evoked by certain odors.
Sensory impressions: Nature and frequency of sensory descriptions associated with odor-evoked memories
Measured: at inclusion
Evaluation of emotional valence of memories evoked by certain odors.
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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start26 Aug 2024 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VIGNAUD Philippe, MD, PhD, Principal investigator, Auvergne-Rhône-Alpes Regional Center for Psychotrauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494306
- Sponsor's protocol ID
- 69HCL24_0189
- Acronym
- TRAUMODO
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Olfactory Perception in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06494306
- Acronym / sponsor ID
- TRAUMODO / 69HCL24_0189
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post traumatic stress disorder, Olfactory perception, Olfaction, Odor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Aug 2024 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PTSD | – | Behavioral: European Test of Olfactory Capabilities (ETOC), Behavioral: Standardized Hedonicity Test, Behavioral: Questionnaires, Behavioral: Odor / trauma association questionnaireThey are outpatients receiving psychological and medical treatment in the clinical department connected to the inclusion site |
| Control group | – | Behavioral: European Test of Olfactory Capabilities (ETOC), Behavioral: Standardized Hedonicity TestData from subjects without PTSD included in a previous study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients aged 18 to 50 suffering from PTSD
Key inclusion criteria (2 listed)
- Age between 18 to 50
- Subjects with PTSD
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| European Test of Olfactory Capabilities (ETOC)Investigators will collect the ETOC score in patient of both arms | Behavioural | Control group, Patients with PTSD |
| Standardized Hedonicity TestTo 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)) | Behavioural | Control group, Patients with PTSD |
| QuestionnairesPatients 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) | Behavioural | Patients with PTSD |
| Odor / trauma association questionnairePatients with PTSD will have Odor / trauma association questionnaire | Behavioural | Patients with PTSD |
Primary outcome
Standardized Hedonicity Test score
Time frame: at inclusion
Results obtained in patients will be compared to those obtained in control group
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VIGNAUD Philippe, MD, PhD principal investigator
Auvergne-Rhône-Alpes Regional Center for Psychotrauma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VIGNAUD Philippe, MD, PhD (+33472116396, philippe.vignaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Hedonicity Test score (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.