Melatonin, temazepam and placebo in hospitalised older patients with sleeping problems (MATCH): a study protocol of randomised controlled trial

• Published in: BMJ open Vol. 9; no. 5; p. e025514
• Main Authors: Stenveld, Fiona, Bosman, Sjanne, van Munster, Barbara C, Beishuizen, Sara J, Hempenius, Liesbeth, van der Velde, Nathalie, Smidt, Nynke, de Rooij, Sophia E
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 22.05.2019; BMJ Publishing Group
• Subjects: Aged; Arousal - drug effects; Benzodiazepines; Delayed-Action Preparations - pharmacology; Delayed-Action Preparations - therapeutic use; Delirium; Evidence-based medicine; Frailty; Geriatric Medicine; Geriatrics; Hospitalization; Humans; Hypnotics and Sedatives - pharmacology; Hypnotics and Sedatives - therapeutic use; Insomnia; Melatonin; Melatonin - pharmacology; Melatonin - therapeutic use; Middle Aged; Multicenter Studies as Topic; Older people; Patient satisfaction; Placebos; Quality; Questionnaires; Randomized Controlled Trials as Topic; Sleep; Sleep - drug effects; Sleep Wake Disorders - drug therapy; Systematic review; Teaching hospitals; Temazepam - pharmacology; Temazepam - therapeutic use; Treatment Outcome; sleep; temazepam; sleep disorders; benzodiazepines; aged; randomised controlled trail; actigraphy; adverse events; melatonin; hospitalisation; insomnia
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-025514

IntroductionHospitalised older patients frequently suffer from inadequate sleep, which can lead to patient distress and delayed recovery from acute illness or surgical procedure. Currently, no evidence-based treatments exist for sleeping problems in hospitalised older patients. Benzodiazepines, such as temazepam, are regularly prescribed by physicians, although they have serious side effects; for older patients in particular. Melatonin is proposed as a safe alternative for sleeping problems in hospitalised older patients, but the efficacy of melatonin is unclear in this population. Therefore, the aim of this study is to investigate the effects of melatonin and temazepam compared with placebo on sleep quality among hospitalised older patients with sleeping problems.Methods and analysisThis study is a multicentre, randomised, placebo-controlled trial. A total of 663 patients will be randomised in a 1:1:1 fashion to receive either melatonin (n=221), temazepam (n=221) or placebo (n=221). The study population consists of hospitalised patients aged 60 years and older, with new or aggravated sleeping problems for which an intervention is needed. The primary outcome is sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ). Secondary outcomes include sleep parameters measured with actigraphy and medication-related adverse effects.Ethics and disseminationThis study was approved by the Medical Ethics Committee of the Academic Medical Centre Amsterdam, (No 2015_302). Study findings will be disseminated through presentations at professional and scientific conferences and publications in peer-reviewed journals.Trial registration numberNTR6908; Pre-results.