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

Academic Medical Center0 个研究点开始时间: 2017年7月6日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 681

•- no understanding of Dutch or English
•- lack of decision making capactity
•- 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(26)
•- 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 esteemed so by the treating physician)

发起方

Academic Medical Center