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

Phase 1

Conditions: Sleeping problems in acutely hospitalized older patients
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2015-003368-35-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 681

Exclusion Criteria

- no understanding of Dutch or English
- lack of decision making capactity
- 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(26)
- 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 esteemed so by the treating physician)