No registrations found.
ID
Source
Brief title
Health condition
Sleeping disorder, acute insomnia.
Slaapstoornis, acute insomnia
Sponsors and support
Email: sejaderooij@gmail.com
Telefoon: (050) 3613921
Adress
Hanzeplein 1
9713 GZ Groningen
Kamer Z3.16,
intern postadres: AA-43
Netherlands
Intervention
Outcome measures
Primary outcome
Sleep quality, measured with the quality of sleep (QOS) parameter of the Leeds Sleep Evaluation Questionnaire (LSEQ).
Secondary outcome
1) 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.
Background summary
The 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).
Study objective
Acutely 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.
Study design
Data will be collected at enrolment, daily during hospitalization (with a maximum of 10 treatment days) and at discharge.
Intervention
Patients 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
Sjanne Bosman
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050- 36113464
s.bosman@umcg.nl
Sjanne Bosman
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050- 36113464
s.bosman@umcg.nl
Inclusion criteria
1. 60 years or older
2. Admitted to the hospital 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 criteria
1. 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, with insufficient information on previous use of sleep medication.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6730 |
| NTR-old | NTR6908 |
| Other | NL55330.018.15 : ABR |