Comparison of melatonin, temazepam and placebo for the treatment of sleep problems in hospitalized older patients.
Suspended
- Conditions
- Sleeping disorder, acute insomnia.Slaapstoornis, acute insomnia
- Registration Number
- NL-OMON21870
- Lead Sponsor
- Prof.dr. S.E.J.A. de Rooij Email: sejaderooij@gmail.comTelefoon: (050) 3613921AdressHanzeplein 19713 GZ GroningenKamer Z3.16, intern postadres: AA-43Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 663
Inclusion Criteria
1.60 years or older
2.Admitted to the hospital for a medical or surgical reason
Exclusion Criteria
1.Inability to speak, understand or write Dutch
2.Lack of decision making capacity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep quality, measured with the quality of sleep (QOS) parameter of the Leeds Sleep Evaluation Questionnaire (LSEQ).
- Secondary Outcome Measures
Name Time Method 1) The other subscales of the LSEQ: getting to sleep (GTS), awakening from sleep (AFS) and behavior following wakening (BFW).<br /><br>2) Good nights of sleep measured with a Numeric Rating Scale (NRS)<br />.<br>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. <br /><br>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.<br><br>