Sleep and biorhythm in ICU patients: a pilot study

Completed

• Conditions: verstoorde secretie van melatonine; Disturbed biorhythm; disturbed sleep; 10040998

• Registration Number: NL-OMON43659
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

ICU patients
> 18 years of age
Expected stay in the ICU 48h or longer
Capable of understanding and speaking Dutch
Richmond agitation and sedation scale (RASS) * -3

Exclusion Criteria

Pre-existing history or treatment of sleep pathology, severe visual or hearing impairment, alcohol addiction or illicit drug abuse
History of cognitive dysfunction (defined as dementia, traumatic brain injury, stroke or hepatic encephalopathy)
Previously discharged from the ICU during this hospital admission
Admission following neurosurgery (since underlying pathology, or the surgery itself, may interfere with sleep and cognitive function)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correlation between sleep continuity and amplitude of melatonin secretion<br /><br>Interrater agreement between methods of sleep analysis (defined by Cohen*s<br /><br>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>Sleep-related parameters (using EEG: Rechtschaffen & Kales (R&K) manual<br /><br>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</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cognitive and behavioural parameters:<br /><br>o ICU delirium by CAM-ICU<br /><br>o ICU delirium manifestation type defined by RASS-scores65 (hypo/hyperactive,<br /><br>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<br /><br>hospital discharge)<br /><br>Amount of administered opioids, benzodiazepines, sedatives and antipsychotics</p><br>