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Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder

Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06221865
Acronym
TRAUMA-TCSP
Enrollment
60
Registered
2024-01-24
Start date
2024-01-15
Completion date
2026-06-01
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder, Sleep Disorder

Keywords

Post Traumatic Stress Disorder, Sleep disorders, Rapid eye movement sleep behavior disorder, Data Correlation

Brief 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.). 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)

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Adult patient aged 18 to 50 years. * French speaking. * Having a diagnosis of type I Posttraumatic Stress Disorder according to DSM 5.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Severity of the Posttraumatic Stress Disorder scoreDay 0This self-questionnaire is completed by the patient during the inclusion visit
Severity of the Rapid Eye Movement Behavior Disorder symptom scoreDay 0This self-questionnaire is completed by the patient during the inclusion visit

Secondary

MeasureTime frameDescription
The Rapid Eye Movement Behavior Disorder Screening Questionnaire scoreDay 0This self-questionnaire is completed by the patient during the inclusion visit
The quality of sleep inventory scoreDay 0This self-questionnaire is completed by the patient during the inclusion visit

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026