Evidence map›Paper›PMID 31122969›Full record

ArticleBMJ open2019

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

Fiona Stenveld, Sjanne Bosman, Barbara C van Munster, Sara J Beishuizen, Liesbeth Hempenius, Nathalie van der Velde, Nynke Smidt, Sophia E de Rooij

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Fiona Stenveld *Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0001-5638-251X
Sjanne Bosman *Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0002-5517-787X
Barbara C van MunsterDepartment of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Sara J BeishuizenDepartment of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands.
Liesbeth HempeniusDepartment of Geriatric Medicine, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
Nathalie van der VeldeDepartment of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands.
Nynke SmidtDepartment of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0002-2778-8841
Sophia E de RooijDepartment of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
University Medical Center Groningen · NLAmsterdam UMC Location University of Amsterdam · NLMedisch Centrum Leeuwarden · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 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.

Indexed as

Delayed-Action PreparationsGeriatricsHypnotics and SedativesMelatoninSleep Wake DisordersTemazepamAgedArousalHospitalizationHumansMiddle AgedMulticenter Studies as TopicPlacebosRandomized Controlled Trials as TopicSleepTreatment OutcomeDelayed-Action PreparationsHypnotics and SedativesMelatoninPlacebosTemazepamactigraphyadverse eventsagedbenzodiazepineshospitalisationinsomniamelatoninrandomised controlled trailsleepsleep disorderstemazepam

Identifiers

PMID31122969
PMCPMC6537975
OpenAlexW2945843695

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.