{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:23:43Z","timestamp":1765826623470,"version":"3.48.0"},"reference-count":64,"publisher":"BMJ","issue":"5","funder":[{"name":"Dalderup Foundation"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,3,19]]},"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NTR6908; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-025514","type":"journal-article","created":{"date-parts":[[2019,5,23]],"date-time":"2019-05-23T08:35:31Z","timestamp":1558600531000},"page":"e025514","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Melatonin, temazepam and placebo in hospitalised older patients with sleeping problems (MATCH): a study protocol of randomised controlled trial"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5638-251X","authenticated-orcid":false,"given":"Fiona","family":"Stenveld","sequence":"first","affiliation":[{"name":"Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5517-787X","authenticated-orcid":false,"given":"Sjanne","family":"Bosman","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands"},{"name":"Department of Geriatric Medicine, Medical Centre Leeuwarden, Leeuwarden, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara C","family":"van Munster","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands"},{"name":"Department of Geriatrics, Gelre Hospitals, Apeldoorn, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara J","family":"Beishuizen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liesbeth","family":"Hempenius","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, Medical Centre Leeuwarden, Leeuwarden, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathalie","family":"van der Velde","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2778-8841","authenticated-orcid":false,"given":"Nynke","family":"Smidt","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands"},{"name":"Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sophia E","family":"de Rooij","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands"},{"name":"Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,5,22]]},"reference":[{"key":"2025121511173404000_9.5.e025514.1","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1016\/j.genhosppsych.2010.01.015","article-title":"Sleep-related problems and use of hypnotics in inpatients of acute hospital wards","volume":"32","author":"Enomoto","year":"2010","journal-title":"Gen Hosp Psychiatry"},{"key":"2025121511173404000_9.5.e025514.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.archger.2010.03.001"},{"key":"2025121511173404000_9.5.e025514.3","first-page":"146","article-title":"Failure of physician documentation of sleep complaints in hospitalized patients","volume":"169","author":"Meissner","year":"1998","journal-title":"West J Med"},{"key":"2025121511173404000_9.5.e025514.4","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1096\/fasebj.10.5.8621064","article-title":"Partial night sleep deprivation reduces natural killer and cellular immune responses in humans","volume":"10","author":"Irwin","year":"1996","journal-title":"Faseb J"},{"key":"2025121511173404000_9.5.e025514.5","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1097\/CCM.0000000000000678","article-title":"When perception may not meet reality","volume":"43","author":"Weinhouse","year":"2015","journal-title":"Crit Care Med"},{"key":"2025121511173404000_9.5.e025514.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60688-1"},{"key":"2025121511173404000_9.5.e025514.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpa.2012.08.005"},{"key":"2025121511173404000_9.5.e025514.8","doi-asserted-by":"crossref","first-page":"4046","DOI":"10.1007\/s12035-015-9350-8","article-title":"Exogenous Melatonin for Delirium Prevention: a Meta-analysis of Randomized Controlled Trials","volume":"53","author":"Chen","year":"2016","journal-title":"Mol Neurobiol"},{"key":"2025121511173404000_9.5.e025514.9","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1111\/jsr.12505","article-title":"Sleep duration and falls: a systemic review and meta-analysis of observational studies","volume":"26","author":"Wu","year":"2017","journal-title":"J Sleep Res"},{"key":"2025121511173404000_9.5.e025514.10","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/20.10.865"},{"key":"2025121511173404000_9.5.e025514.11","doi-asserted-by":"publisher","DOI":"10.1177\/0885066610394322"},{"key":"2025121511173404000_9.5.e025514.12","unstructured":"Nederlande Internisten vereniging. Evidence-based richtlijn nieuwe of verergerende slaapproblemen bij acuut opgenomen ouderen in het ziekenhuis of verpleeghuis. Richtlijn 2015:1\u201389."},{"key":"2025121511173404000_9.5.e025514.13","doi-asserted-by":"publisher","DOI":"10.1002\/jhm.397"},{"key":"2025121511173404000_9.5.e025514.14","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1A040"},{"key":"2025121511173404000_9.5.e025514.15","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1007\/s11606-013-2640-9","article-title":"Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review","volume":"29","author":"Tamrat","year":"2014","journal-title":"J Gen Intern Med"},{"key":"2025121511173404000_9.5.e025514.16","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-012108","article-title":"Pharmacological interventions to improve sleep in hospitalised adults: a systematic review","volume":"6","author":"Kanji","year":"2016","journal-title":"BMJ Open"},{"key":"2025121511173404000_9.5.e025514.17","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-2-17"},{"key":"2025121511173404000_9.5.e025514.18","doi-asserted-by":"crossref","first-page":"652","DOI":"10.1002\/jhm.2246","article-title":"Inpatient pharmacological sleep aid utilization is common at a tertiary medical center","volume":"9","author":"Gillis","year":"2014","journal-title":"J Hosp Med"},{"key":"2025121511173404000_9.5.e025514.19","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.38623.768588.47"},{"key":"2025121511173404000_9.5.e025514.20","doi-asserted-by":"publisher","DOI":"10.2165\/00023210-200317110-00004"},{"key":"2025121511173404000_9.5.e025514.21","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1007\/s40268-017-0207-7","article-title":"Benzodiazepines and Z-Drugs: An Updated Review of Major Adverse Outcomes Reported on in Epidemiologic Research","volume":"17","author":"Brandt","year":"2017","journal-title":"Drugs R D"},{"key":"2025121511173404000_9.5.e025514.22","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2648.1994.tb01052.x"},{"key":"2025121511173404000_9.5.e025514.23","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1497.2005.0243.x"},{"key":"2025121511173404000_9.5.e025514.24","doi-asserted-by":"publisher","DOI":"10.1002\/gps.2454"},{"key":"2025121511173404000_9.5.e025514.25","doi-asserted-by":"publisher","DOI":"10.1177\/1533317514539379"},{"key":"2025121511173404000_9.5.e025514.26","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199701163360306"},{"key":"2025121511173404000_9.5.e025514.27","doi-asserted-by":"publisher","DOI":"10.1185\/030079907X233098"},{"key":"2025121511173404000_9.5.e025514.28","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2869.2007.00613.x"},{"key":"2025121511173404000_9.5.e025514.29","doi-asserted-by":"publisher","DOI":"10.1186\/cc6871"},{"key":"2025121511173404000_9.5.e025514.30","doi-asserted-by":"publisher","DOI":"10.1081\/CBI-100101033"},{"key":"2025121511173404000_9.5.e025514.31","first-page":"187","article-title":"A double-blind placebo-controlled randomised pilot study of nocturnal melatonin in tracheostomised patients","volume":"8","author":"Ibrahim","year":"2006","journal-title":"Crit Care Resusc"},{"key":"2025121511173404000_9.5.e025514.32","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v62n0109"},{"key":"2025121511173404000_9.5.e025514.33","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1016\/j.ijsu.2014.12.007","article-title":"The SPIRIT 2013 statement--defining standard protocol items for trials","volume":"13","author":"Agha","year":"2015","journal-title":"Int J Surg"},{"key":"2025121511173404000_9.5.e025514.34","unstructured":"ICH. Integrated addendum to ICH e6(R1): Guideline for good clinical practice ICH, 2016."},{"key":"2025121511173404000_9.5.e025514.35","doi-asserted-by":"publisher","DOI":"10.1007\/s40266-014-0178-0"},{"key":"2025121511173404000_9.5.e025514.36","unstructured":"Zorginstituut Nederland. Temazepam benzodiazepine agonisten | N05CD07. https:\/\/www.farmacotherapeutischkompas.nl\/bladeren\/preparaatteksten\/t\/temazepam (accessed 4 Nov 2017)."},{"key":"2025121511173404000_9.5.e025514.37","doi-asserted-by":"publisher","DOI":"10.1007\/BF00434408"},{"key":"2025121511173404000_9.5.e025514.38","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1002\/hup.534","article-title":"Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients","volume":"18","author":"Tarrasch","year":"2003","journal-title":"Hum Psychopharmacol"},{"key":"2025121511173404000_9.5.e025514.39","unstructured":"Van Beuningen J , van der Houwen K , Moonen L . Measuring well-being An analysis of different response scales. The Hague\/Heerlen 2014 www.cbs.nl"},{"key":"2025121511173404000_9.5.e025514.40","doi-asserted-by":"publisher","DOI":"10.1046\/j.0962-1105.2003.00365.x"},{"key":"2025121511173404000_9.5.e025514.41","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.140495"},{"key":"2025121511173404000_9.5.e025514.42","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1001\/jamainternmed.2018.2669","article-title":"Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients","volume":"178","author":"Wesselius","year":"2018","journal-title":"JAMA Intern Med"},{"key":"2025121511173404000_9.5.e025514.43","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijsu.2011.10.001"},{"key":"2025121511173404000_9.5.e025514.44","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291700014379"},{"key":"2025121511173404000_9.5.e025514.45","doi-asserted-by":"publisher","DOI":"10.1097\/00007632-200012150-00014"},{"key":"2025121511173404000_9.5.e025514.46","doi-asserted-by":"crossref","first-page":"287","DOI":"10.5665\/sleep.1642","article-title":"The consensus sleep diary: standardizing prospective sleep self-monitoring","volume":"35","author":"Carney","year":"2012","journal-title":"Sleep"},{"key":"2025121511173404000_9.5.e025514.47","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1111\/ggi.12743","article-title":"What affects the subjective sleep quality of hospitalized elderly patients?","volume":"17","author":"Park","year":"2017","journal-title":"Geriatr Gerontol Int"},{"key":"2025121511173404000_9.5.e025514.48","doi-asserted-by":"crossref","first-page":"267","DOI":"10.3389\/fneur.2014.00267","article-title":"The influence of environmental factors on sleep quality in hospitalized medical patients","volume":"5","author":"Bano","year":"2014","journal-title":"Front Neurol"},{"key":"2025121511173404000_9.5.e025514.49","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2702.1999.00267.x"},{"key":"2025121511173404000_9.5.e025514.50","doi-asserted-by":"crossref","first-page":"e0156735","DOI":"10.1371\/journal.pone.0156735","article-title":"Sleep Quality and Factors Influencing Self-Reported Sleep Duration and Quality in the General Internal Medicine Inpatient Population","volume":"11","author":"Dobing","year":"2016","journal-title":"PLoS One"},{"key":"2025121511173404000_9.5.e025514.51","doi-asserted-by":"publisher","DOI":"10.1016\/0022-3956(75)90026-6"},{"key":"2025121511173404000_9.5.e025514.52","doi-asserted-by":"publisher","DOI":"10.1037\/h0054651"},{"key":"2025121511173404000_9.5.e025514.53","unstructured":"Hammes J . De stroop Kleur-woord test: handleiding [The Stroop Color-word test: manual]: Lisse, 1997."},{"key":"2025121511173404000_9.5.e025514.54","unstructured":"Army Individual Test Battery. Manual of directions and scoring. Washington, DC: War Dep Adjut Gen Off, 1944."},{"key":"2025121511173404000_9.5.e025514.55","unstructured":"Lezak DBH MD . Neuropsychological assessment. 4th edn. New York: Oxford University Press, 2004."},{"key":"2025121511173404000_9.5.e025514.56","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afu021"},{"key":"2025121511173404000_9.5.e025514.57","doi-asserted-by":"crossref","unstructured":"American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th edn. Washington: DC, 2013.","DOI":"10.1176\/appi.books.9780890425596"},{"key":"2025121511173404000_9.5.e025514.58","doi-asserted-by":"publisher","DOI":"10.1016\/S1389-9457(00)00065-4"},{"key":"2025121511173404000_9.5.e025514.59","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2011.06.008"},{"key":"2025121511173404000_9.5.e025514.60","doi-asserted-by":"crossref","first-page":"848","DOI":"10.1007\/s12603-014-0558-5","article-title":"Validity and reliability of the Katz-15 scale to measure unfavorable health outcomes in community-dwelling older people","volume":"18","author":"Laan","year":"2014","journal-title":"J Nutr Health Aging"},{"key":"2025121511173404000_9.5.e025514.61","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.1992.tb02107.x"},{"key":"2025121511173404000_9.5.e025514.62","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.1990.434"},{"key":"2025121511173404000_9.5.e025514.63","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(87)90171-8"},{"key":"2025121511173404000_9.5.e025514.64","first-page":"A8491","article-title":"[Predictive value of the VMS theme \u2019Frail elderly': delirium, falling and mortality in elderly hospital patients]","volume":"159","author":"Oud","year":"2015","journal-title":"Ned Tijdschr Geneeskd"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-025514","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:17:42Z","timestamp":1765826262000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-025514"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,5]]},"references-count":64,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2019,5,22]]},"published-print":{"date-parts":[[2019,5]]}},"alternative-id":["10.1136\/bmjopen-2018-025514"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-025514","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2019,5]]}}}