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Comparison of melatonin, temazepam and placebo for the treatment of sleep problems in hospitalized older patients.


- candidate number28356
- NTR NumberNTR6908
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2017
- Secondary IDsABR NL55330.018.15
- Public TitleComparison of melatonin, temazepam and placebo for the treatment of sleep problems in hospitalized older patients.
- Scientific TitleMelAtonin, Temazepam and plaCebo in Hospitalized older patients with sleeping problems.
- ACRONYMMATCH
- hypothesisAcutely hospitalized older patients frequently suffer from inadequate sleep. Insufficient sleep can lead to patient distress and delayed recovery from acute illness or a surgical procedure. Currently, no evidence-based treatments exist for sleeping problems in acutely hospitalized 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 acutely hospitalized 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, temazepam and placebo on sleep quality among acutely hospitalized older patients with sleeping problems.
- Healt Condition(s) or Problem(s) studiedSleeping disorder, Acute insomnia
- Inclusion criteria1. 65 years or older
2. Acutely admitted for a medical or surgical reason
3. Experiencing new onset or aggravated sleep problems, for which an intervention is needed
4. Able to fill out a sleep questionnaire
- Exclusion criteria1. Inability to speak, understand or write Dutch
2. Lack of decision making capacity
3. Previously diagnosed dementia
4. Transferred from another hospital to one of the study centers
5. Expected stay in hospital of <48 hours
6. Concurrent regular benzodiazepine or melatonin use
7. Alcohol consumption >13 units/week for women and >20 units/week for men
8. Drug interactions with melatonin or contra indications for benzodiazepine use
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate31-dec-2020
- Target number of participants663
- InterventionsPatients are randomized to receive 1 out of 3 possible treatments:

Treatment 1: Melatonin
Dose: 1mg daily, ante nocte (with a maximum of 10 days)
Administration: Orally

Treatment 2: Temazepam
Dose: 10mg daily, ante nocte (with a maximum of 10 days)
Administration: Orally

Treatment 3: Placebo (control)
Dose: placebo, ante nocte (with a maximum of 10 days)
Administration: Orally
- Primary outcomeSleep quality, measured with the quality of sleep (QOS) parameter of the Leeds Sleep Evaluation Questionnaire (LSEQ).
- Secondary outcome1) The other subscales of the LSEQ: getting to sleep (GTS), awakening from sleep (AFS) and behavior following wakening (BFW).
2) Good nights of sleep measured with a Numeric Rating Scale (NRS)
. 3) Objective sleep parameters measured with actigraphy: sleep onset latency in minutes, sleep efficiency, number and duration of wake bouts and time awake after sleep onset in minutes.
4) Side effects related to study medication: Incidence of delirium during hospitalization, cognition, number of falls during hospitalization, complications and length of hospital stay in days.
- TimepointsData will be collected at enrolment, daily during hospitalization (with a maximum of 10 treatment days) and at discharge.
- Trial web siten.v.t.
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Sjanne Bosman
- CONTACT for SCIENTIFIC QUERIESDr. S.E.J.A. Rooij, de
- Sponsor/Initiator Prof. dr. S.E.J.A. de Rooij
- Funding
(Source(s) of Monetary or Material Support)
Amsterdams universiteitsfonds
- Publications
- Brief summaryThe aim of the MATCH study is to investigate the effects of melatonin, temazepam and placebo on sleep quality among acutely hospitalized older patients with sleeping problems.
This study is a multicenter, randomized controlled trial in the Netherlands. A total of 663 patients will be randomized in a 1:1:1 fashion to receive melatonin (n=221), temazepam (n=221) or placebo (n=221). The study population consists of acutely hospitalized patients aged 65 years and older, with new or aggravated sleeping problems for which an intervention is needed. Measurements will be collected at enrolment , daily during hospitalization (with a maximum of 10 treatment days) and at discharge. The primary outcome is sleep quality measured with the Leeds Sleep Evaluation Questionanaire (LSEQ).
- Main changes (audit trail)
- RECORD18-dec-2017 - 4-jan-2018


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