跳至主要内容
临床试验/NCT06221865
NCT06221865尚未招募不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Severity of the Posttraumatic Stress Disorder score

研究概览

简要总结

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).

详细描述

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 :

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Severity of the Posttraumatic Stress Disorder score

时间窗: Day 0

This self-questionnaire is completed by the patient during the inclusion visit

Severity of the Rapid Eye Movement Behavior Disorder symptom score

时间窗: Day 0

This self-questionnaire is completed by the patient during the inclusion visit

次要结局

  • The Rapid Eye Movement Behavior Disorder Screening Questionnaire score(Day 0)
  • The quality of sleep inventory score(Day 0)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验