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Melatonin, temazepam and placebo in hospitalised older patients with sleeping problems (MATCH): a study protocol of randomised controlled trial
  1. Fiona Stenveld1,
  2. Sjanne Bosman1,2,
  3. Barbara C van Munster1,3,
  4. Sara J Beishuizen4,
  5. Liesbeth Hempenius2,
  6. Nathalie van der Velde4,
  7. Nynke Smidt1,5,
  8. Sophia E de Rooij1,4
  1. 1 Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
  2. 2 Department of Geriatric Medicine, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  3. 3 Department of Geriatrics, Gelre Hospitals, Apeldoorn, The Netherlands
  4. 4 Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands
  5. 5 Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, The Netherlands
  1. Correspondence to Ms. Sjanne Bosman; s.bosman{at}umcg.nl

Abstract

Introduction Hospitalised 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 analysis This 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 dissemination This 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 number NTR6908; Pre-results.

  • hospitalisation
  • aged
  • melatonin
  • benzodiazepines
  • temazepam
  • sleep
  • sleep disorders
  • insomnia
  • randomised controlled trail
  • actigraphy
  • adverse events

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • FS and SB contributed equally.

  • Contributors FS and SB contributed equally to this paper. SDR is responsible for the original conception of the study and obtaining the grant. FS, SB, SJB, NS, BCvM, NvdV, LH and SDR attributed to the design of the study. FS and SB wrote the first draft of the manuscript, all authors contributed to further drafts. All authors read and approved the final draft.

  • Funding The MATCH-trial is unrestrictedly financed by the Dalderup foundation.

  • Competing interests None declared.

  • Ethics approval This study was approved by the Medical Research Ethics Committee of the Academic Medical Centre Amsterdam in June 2017. Reference number: 2015_302. The executive boards of the other participating centres have provided local feasibility approval.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Correction notice This article has been corrected since it first published online. The open access licence type has been amended.

  • Patient consent for publication Not required.

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