acute insomnia Sleeping disorder
Conditions
Interventions
Patients will be randomized to receive either 1mg melatonin, 10mg temazepam or
placebo ante noctem daily for a maximum of ten hospital days
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - aged 65 years or older - acutely admitted for a medical or surgical reason - experiencing new onset or aggravated sleep problems, for which the patient/nurse/treating physician expresses a need for intervention - willing and medically able to receive therapy according to the protocol for the duration of the study - able to fill out the sleep questionnaire that serves as primary outcome measurement (Leeds Sleep Evaluation Questionnaire) - agreeing to informed consent
Exclusion criteria
Exclusion criteria: - no understanding of Dutch or English - lack of decision making capacity - previously diagnosed with dementia - transferred from another hospital to one of the study centres - transferred from another ward (ICU, CCU etc) to one of the study wards - expected stay in hospital of 1 doses/week) - concurrent regular melatonin use (>1 doses/week) - alcohol consumption >13 units/week for women and >20 units/week for men(24) - concurrent use of: chinolones, rifampicine, fluvoxamine, carbamazepine - having a medical condition that is a contra indication for benzodiazepine use (allergy to benzodiazepines, hepatic failure (Child-Pugh C), kidney disease requiring dialysis, risk of respiratory depression (as clinically esteemed so by the attending physician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in sleep quality, as measured the Leeds Sleep Evaluation Questionaire (LSEQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in other subjective sleep parameters: getting to sleep (GTS), awakening from sleep AFS) and behaviour following wakening (BFW), measured by the LSEQ 2. Improvement in objective sleep parameters: reduction in sleep onset latency in minutes, sleep efficiency, number and duration of wake bouts, time awake after sleep onset in minutes, measured by actigraphy 3. Short term cognitive measures (reaction time: digit-symbol substitution test, recall: word-list free-recall procedure) 4. Adverse drug events related to study medication, assessed with the method of Narango.(38) 5. Incidence of delirium during hospitalization 6. Number of falls during hospitalization 7. All complications officially added to the hospitals* complication register 8. Length of hospital stay in days 9. Quality of life, measured by EQ5D 10. Chronic use of sleep medications after discharge 11. Mortality during hospitalization and at follow up 12. Exploratory endpoint: laboratory results on kidney and liver measures, if available | — |
Countries
Netherlands
Outcome results
None listed