ClinicalTrials.Veeva

Menu

Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder (TRAUMA-TCSP)

U

University Hospital, Clermont-Ferrand

Status

Not yet enrolling

Conditions

Post Traumatic Stress Disorder
Sleep Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT06221865
RNI 2023 FANTINI

Details and patient eligibility

About

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).

Full 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)

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

Loading...

Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems