跳至主要内容
临床试验/NL-OMON46069
NL-OMON46069已完成4 期

Melatonin Against Temazepam in Comparing adverse events in vulnerable elderly Hospitalized patients with sleeping problems - MATCH

Academisch Medisch Centrum0 个研究点目标入组 717 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
717

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - aged 65 years or older
  • - acutely admitted for a medical or surgical reason
  • - experiencing new onset or aggravated sleep problems, for which the patient/nurse/treating physician expresses a need for intervention
  • - willing and medically able to receive therapy according to the protocol for the duration of the study
  • - able to fill out the sleep questionnaire that serves as primary outcome measurement (Leeds Sleep
  • Evaluation Questionnaire)
  • - agreeing to informed consent

排除标准

  • - no understanding of Dutch or English
  • - lack of decision making capacity
  • - previously diagnosed with dementia
  • - transferred from another hospital to one of the study centres
  • - transferred from another ward (ICU, CCU etc) to one of the study wards
  • - expected stay in hospital of <48 hours
  • - concurrent regular benzodiazepine use (>1 doses/week)
  • - concurrent regular melatonin use (>1 doses/week)
  • - alcohol consumption >13 units/week for women and >20 units/week for men(24)
  • - concurrent use of: chinolones, rifampicine, fluvoxamine, carbamazepine
  • - having a medical condition that is a contra indication for benzodiazepine use (allergy to benzodiazepines, hepatic failure (Child-Pugh C), kidney disease requiring dialysis, risk of respiratory depression (as clinically esteemed so by the attending physician)

研究者

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