Melatonin Against Temazepam in Comparing adverse events in vulnerable elderly Hospitalized patients with sleeping problems
- Conditions
- acute insomniaSleeping disorder10040991
- Registration Number
- NL-OMON46069
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 717
- 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
- 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 <48 hours
- concurrent regular benzodiazepine use (>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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Improvement in sleep quality, as measured the Leeds Sleep Evaluation<br /><br>Questionaire (LSEQ)</p><br>
- Secondary Outcome Measures
Name Time Method