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Sleep and biorhythm in ICU patients: a pilot study

Sleep and biorhythm in ICU patients: a pilot study - Sleep and biorhythm in the ICU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43659
Enrollment
70
Registered
2015-08-04
Start date
2015-08-10
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verstoorde secretie van melatonine Disturbed biorhythm disturbed sleep

Interventions

None listed

Sponsors

Philips
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Correlation between sleep continuity and amplitude of melatonin secretion Interrater agreement between methods of sleep analysis (defined by Cohen*s Kappa): o R&K analysis and IDOS index o Somnolyzer score and IDOS index o Actigraphy and IDOS index Sleep-related parameters (using EEG: Rechtschaffen & Kales (R&K) manual scoring, and IDOS method): o total sleep time (any sleep stage other than awake, EEG) o number of awakenings and arousals o sleep efficiency o sleep continuity Biorhythm: o time and amplitude of concentration of melatonin secretion o minimum melatonin concentration o difference between peak and minimum

Secondary

MeasureTime frame
Cognitive and behavioural parameters: o ICU delirium by CAM-ICU o ICU delirium manifestation type defined by RASS-scores65 (hypo/hyperactive, or mixed) o duration of ICU delirium o clinical requirement for pharmacological intervention (haloperidol) Environmental parameters: o light levels (lux) o light frequencies o noise levels (decibel), and number of peaks exceeding 65dB o temperature (degrees Celsius) ICU and hospital length of stay Mortality (until ICU discharge, hospital discharge, 6 and 12 months after hospital discharge) Amount of administered opioids, benzodiazepines, sedatives and antipsychotics

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 4, 2026