Sleep and biorhythm in the IC
Recruiting
- Conditions
- Melatonin secretion, quality of sleep, incidence of delirium.
- Registration Number
- NL-OMON26764
- Lead Sponsor
- PERFORMERDepartment of Critical Care(in Dutch: Intensive Care Volwassenen)University Medical Center GroningenHanzeplein 1, 9700 RB GroningenThe NetherlandsTel: + 31 50 361 2327SPONSORPatient Care & MeasurementsPhilips Research EindhovenHigh Tech Campus 34, 5656 AE EindhovenThe NetherlandsTel: +31 40 2742370
- Brief Summary
Reinke, L., van der Hoeven, J. H., van Putten, M. J., Dieperink, W. & Tulleken, J. E. Intensive care unit depth of sleep: proof of concept of a simple electroencephalography index in the non-sedated. Crit. Care 18, R66 (2014).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
ICU patients
Capable of giving informed consent
Exclusion Criteria
Preexisting
history or treatment of sleep pathology, severe visual or hearing impairment, alcohol addiction or
illicit drug abuse
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between sleep continuity and amplitude of melatonin secretion<br /><br>Interrater agreement between methods of sleep analysis (defined by Cohen’s Kappa):<br /><br>o R&K analysis and IDOS index<br /><br>o Somnolyzer score and IDOS index<br /><br>o Actigraphy and IDOS index<br /><br>Sleeprelated<br>parameters (using EEG: Rechtschaffen & Kales (R&K) manual scoring, and IDOS method):<br /><br>o total sleep time (any sleep stage other than awake, EEG)<br /><br>o number of awakenings and arousals<br /><br>o sleep efficiency<br /><br>o sleep continuity<br /><br>Biorhythm:<br /><br>o time and amplitude of concentration of melatonin secretion<br /><br>o minimum melatonin concentration<br /><br>o difference between peak and minimum<br />
- Secondary Outcome Measures
Name Time Method Cognitive and behavioural parameters:<br /><br>o ICU delirium by CAMICU<br /><br>o ICU delirium manifestation type defined by RASSscores65<br>(hypo/hyperactive, or mixed)<br /><br>o duration of ICU delirium<br /><br>o clinical requirement for pharmacological intervention (haloperidol)<br /><br>Environmental parameters:<br /><br>o light levels (lux)<br /><br>o light frequencies<br /><br>o noise levels (decibel), and number of peaks exceeding 65dB<br /><br>o temperature (degrees Celsius)<br /><br>ICU and hospital length of stay<br /><br>Mortality (until ICU discharge, hospital discharge, 6 and 12 months after hospital discharge)<br /><br>Amount of administered opioids, benzodiazepines, sedatives and antipsychotics<br />