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临床试验/NCT03068598
NCT03068598已完成不适用

Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Acceptability of the sleep recorder device in patients with previous history of suicide attempts

研究概览

简要总结

Promising results have shown that interventions to reduce insomnia diminish suicidal ideation. A better understanding of the bidirectional mechanism between sleep disturbances and suicide behavior will allow the design of tailored interventions to prevent suicide attempts.

Significance of the proposed study for the field The aim of the present is to assess the feasibility and the acceptability of sleep tracking monitoring in a sample of suicide attempters. The investigator hypothesize that sleep monitoring using a connected object is feasable and acceptable by patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

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

  • male or female, aged 18 or older,
  • with suicide attempt or suicidal ideas history,
  • able to understand the study,
  • insured persons,
  • having signed a consent form.

排除标准

  • minor patient,
  • patient whose clinical status is incompatible with informed consent,
  • patient tattooed on both wrists
  • patient under guardianship or curatorship

结局指标

主要结局

Acceptability of the sleep recorder device in patients with previous history of suicide attempts

时间窗: 5 days after discharge

Score obtained at the scale evaluating acceptability of the sleep recorder device during the study exit interview 5 days after inclusion

次要结局

  • Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep.(5 days after discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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