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

Post Traumatic Stress Disorder Clinical Trial

— TRAUMA-TCSP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221865
• Other study ID #: RNI 2023 FANTINI
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.).

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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Parasomnias
• Post Traumatic Stress Disorder
• Sleep Disorder
• Sleep Wake Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of the Posttraumatic Stress Disorder score	This self-questionnaire is completed by the patient during the inclusion visit	Day 0
Primary	Severity of the Rapid Eye Movement Behavior Disorder symptom score	This self-questionnaire is completed by the patient during the inclusion visit	Day 0
Secondary	The Rapid Eye Movement Behavior Disorder Screening Questionnaire score	This self-questionnaire is completed by the patient during the inclusion visit	Day 0
Secondary	The quality of sleep inventory score	This self-questionnaire is completed by the patient during the inclusion visit	Day 0