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临床试验/NCT03793699
NCT03793699终止不适用

Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
24
试验地点
2
主要终点
Sleep disorders intensity by the Insomnia Severity Index (ISI)

研究概览

简要总结

Several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors.

Nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. Furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena.

Today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. Indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts.

The objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt

详细描述

Pilot, prospective, monocentric case-control study.

There are 2 groups of subjects :

  • group of patients who have made a suicide attempt
  • control group with only suicidal ideas

First visit V1 is performed within the first 72 hours of hospitalization. A re-assessment is scheduled 1 month after (V2).

At V1, collected parameters are : chronic sleep disorders, chronotype, specific sleep disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Criterion specific to the studying group :
  • - Subjects hospitalized and whose indication of hospitalization is a suicide attempt by voluntary drug intoxication or phlebotomy during the last 72 hours, without any history of attempted suicide
  • Criterion specific to the control group:
  • - Subjects hospitalized since less than 72 hours, and whose indication of hospitalization is the presence of suicidal ideas, without any history of attempted suicide

排除标准

  • Pregnant of lactating women
  • Diagnosed dementia pathology
  • Proven intellectual disability
  • Patient whose physical or mental state does not allow the passing of the tests of the study
  • Under protective measures (guardianship/supervision)
  • Refusal to participate in the study
  • Diagnosed with chronic or severe psychiatric illness (psychotic disorder, bipolarity)

结局指标

主要结局

Sleep disorders intensity by the Insomnia Severity Index (ISI)

时间窗: at the 48 hours after the hospitalization; at the maximum within 72 hours.

ISI score in the last 2 weeks between a group of suicide attempts and a group with suicidal thoughts suicidal The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score.

次要结局

  • Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score(Baseline (visit inclusion) and at one month ago)
  • Evolution of ISI score(At one month +/- 15 days ant at 3 months +/-3 weeks)
  • Chronotype classification by MCTQ(at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks)
  • Pittsburg Sleep Quality Index (PSQI) score(at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks)
  • Childhood Trauma Questionnaire (CTQ) score(at the 48 hours after the hospitalization; at the maximum within 72 hours.)
  • Montréal Cognitive Assessment (MocA)(at the 48 hours after the hospitalization; at the maximum within 72 hours.)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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