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

NCT ID: NCT06221865

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2026-06-01

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)

Conditions

Post Traumatic Stress Disorder; Sleep Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Livia Fantini

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

Other Identifiers

RNI 2023 FANTINI

Identifier Type: -

Identifier Source: org_study_id