NL-OMON46069已完成4 期
Melatonin Against Temazepam in Comparing adverse events in vulnerable elderly Hospitalized patients with sleeping problems - MATCH
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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