Post Traumatic Stress DisorderTRAUMA-TCSPNCT06221865
Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder
An observational study of Post Traumatic Stress Disorder and Sleep Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Post-Traumatic Stress Disorder is a psychiatric disorder that occurs after a traumatic event and is estimated to affect 5 to 12% of the general population. Around 70% of patients suffering from this disorder report sleep disorders (sleep apnea, insomnia, recurring nightmares, etc.). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Sleep Disorder
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to 1 Jun 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: 60 patients suffering from type 1 Post-traumatic Stress Disorder (PTSD) will be included in this study. They will be selected during their consultation at the CUMP (Cellule d'Urgence Medico Psychologique) of the hospital of Clermont-Ferrand.
Who may be able to join
- Adult patient aged 18 to 50 years.
- French speaking.
- Having a diagnosis of type I Posttraumatic Stress Disorder according to DSM 5.
Who cannot join
- Presence of acute mental illnesses in the process of decompensation.
- Presence of a Central Nervous System disorder (e.g. neurodegenerative diseases, Stroke, Multiple Sclerosis (MS), Narcolepsy, etc.)
- Patient under guardianship, curatorship, or legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Post-Traumatic Stress Disorder is a psychiatric disorder that occurs after a traumatic event and is estimated to affect 5 to 12% of the general population. Around 70% of patients suffering from this disorder report sleep disorders (sleep apnea, insomnia, recurring nightmares, etc.).
There are specific sleep disorders called Rapid Eye Movement (REM) sleep behavior disorders which correspond to nocturnal restlessness with sometimes violent behavior, often associated with intense dreams during a phase of sleep called REM sleep. These disorders are more frequently found in patients suffering from post-traumatic stress, such as veterans.
Read more
However, the physiopathological link between these two disorders is poorly understood and studies on this subject are few in number. Through this study, the investigators wish to demonstrate whether there is a correlation between the severity of Post-Traumatic Stress Disorder and that of Rapid Eye Movement sleep behavior disorder.
The main objective is to study the relationship between the severity of Post Traumatic Stress Disorder (PTSD) and the Rapid Eye Movement (REM) Sleep Behavior Disorder.
This is an observational prospective study based on 4 questionnaires relating to the sleep (PSQI), the severity of the Rapid Eye Movement (REM) Sleep Behavior Disorder (REM RBDSQ, IRBD-SSS) and the severity of the Post-Traumatic Stress Disorder (PCL-5).
Read the detailed description
Type of study: observational prospective study
Study duration : 40 min, one visit at D0 (inclusion isit)
Number of center: 1 (Clermont Ferrand)
Patients: 60 patients suffering from type 1 Post-traumatic Stress Disorder .
Patients will be selected during their consultation, at the CUMP (Medico-Psychological Emergency Cell) of the hospital of Clermont-Ferrand. If patients accept to participate to this study, demographic and clinical data (age, sex, current treatments, medical and surgical history) will be collected. Then, they will complete 4 questionnaires :
- the Rapid Eye Movement Behavior Disorder Screening Questionnaire (REM RBDSQ)
- the Rapid Eye Movement Behavior Disorder symptom severity scale score (IRBDSSS)
- the quality of sleep inventory (PSQI)
- the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL 5)
- Conditions
- Post Traumatic Stress Disorder, Sleep Disorder
- Keywords
- Post Traumatic Stress Disorder, Sleep disorders, Rapid eye movement sleep behavior disorder, Data Correlation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders, REM Sleep Behavior Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of the Posttraumatic Stress Disorder score
This self-questionnaire is completed by the patient during the inclusion visit
Measured: Day 0
Severity of the Rapid Eye Movement Behavior Disorder symptom score
This self-questionnaire is completed by the patient during the inclusion visit
Measured: Day 0
Secondary outcomes (2)
The Rapid Eye Movement Behavior Disorder Screening Questionnaire score
This self-questionnaire is completed by the patient during the inclusion visit
Measured: Day 0
The quality of sleep inventory score
This self-questionnaire is completed by the patient during the inclusion visit
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion1 Jun 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Livia Fantini, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221865
- Sponsor's protocol ID
- RNI 2023 FANTINI
- Acronym
- TRAUMA-TCSP
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT06221865
- Acronym / sponsor ID
- TRAUMA-TCSP / RNI 2023 FANTINI
- Conditions
- Post Traumatic Stress Disorder, Sleep Disorder
- Keywords
- Post Traumatic Stress Disorder, Sleep disorders, Rapid eye movement sleep behavior disorder, Data Correlation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Jan 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.
Post-Traumatic Stress Disorder is a psychiatric disorder that occurs after a traumatic event and is estimated to affect 5 to 12% of the general population. Around 70% of patients suffering from this disorder report sleep disorders (sleep apnea, insomnia, recurring nightmares, etc.).
There are specific sleep disorders called Rapid Eye Movement (REM) sleep behavior disorders which correspond to nocturnal restlessness with sometimes violent behavior, often associated with intense dreams during a phase of sleep called REM sleep. These disorders are more frequently found in patients suffering from post-traumatic stress, such as veterans.
However, the physiopathological link between these two disorders is poorly understood and studies on this subject are few in number. Through this study, the investigators wish to demonstrate whether there is a correlation between the severity of Post-Traumatic Stress Disorder and that of Rapid Eye Movement sleep behavior disorder.
The main objective is to study the relationship between the severity of Post Traumatic Stress Disorder (PTSD) and the Rapid Eye Movement (REM) Sleep Behavior Disorder.
This is an observational prospective study based on 4 questionnaires relating to the sleep (PSQI), the severity of the Rapid Eye Movement (REM) Sleep Behavior Disorder (REM RBDSQ, IRBD-SSS) and the severity of the Post-Traumatic Stress Disorder (PCL-5).
Detailed description
Type of study: observational prospective study
Study duration : 40 min, one visit at D0 (inclusion isit)
Number of center: 1 (Clermont Ferrand)
Patients: 60 patients suffering from type 1 Post-traumatic Stress Disorder .
Patients will be selected during their consultation, at the CUMP (Medico-Psychological Emergency Cell) of the hospital of Clermont-Ferrand. If patients accept to participate to this study, demographic and clinical data (age, sex, current treatments, medical and surgical history) will be collected. Then, they will complete 4 questionnaires :
- the Rapid Eye Movement Behavior Disorder Screening Questionnaire (REM RBDSQ)
- the Rapid Eye Movement Behavior Disorder symptom severity scale score (IRBDSSS)
- the quality of sleep inventory (PSQI)
- the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL 5)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 patients suffering from type 1 Post-traumatic Stress Disorder (PTSD) will be included in this study. They will be selected during their consultation at the CUMP (Cellule d'Urgence Medico Psychologique) of the hospital of Clermont-Ferrand.
Key inclusion criteria (3 listed)
- Adult patient aged 18 to 50 years.
- French speaking.
- Having a diagnosis of type I Posttraumatic Stress Disorder according to DSM 5.
Key exclusion criteria (3 listed)
- Presence of acute mental illnesses in the process of decompensation.
- Presence of a Central Nervous System disorder (e.g. neurodegenerative diseases, Stroke, Multiple Sclerosis (MS), Narcolepsy, etc.)
- Patient under guardianship, curatorship, or legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of the Posttraumatic Stress Disorder score
Time frame: Day 0
This self-questionnaire is completed by the patient during the inclusion visit
Severity of the Rapid Eye Movement Behavior Disorder symptom score
Time frame: Day 0
This self-questionnaire is completed by the patient during the inclusion visit
2 secondary outcomes
The Rapid Eye Movement Behavior Disorder Screening Questionnaire score
Time frame: Day 0
The quality of sleep inventory score
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Related trials for Post Traumatic Stress Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
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.
Livia Fantini principal investigator
University Hospital, Clermont-Ferrand
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 and Sleep Disorder, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 3 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 24 Jan 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 Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of the Posttraumatic Stress Disorder score (time frame: Day 0). The study lists 2 primary outcomes in all. 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 24 Jan 2024.