Sleep and biorhythm in the ICU

Sleep and biorhythm in ICU patients: a pilot study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26764

Enrollment

Registered

2015-08-04

Start date

2015-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Melatonin secretion, quality of sleep, incidence of delirium.

Interventions

- none

Eligibility

Inclusion criteria

Inclusion criteria: ICU patients Capable of giving informed consent > 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: Preexisting 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

Measure	Time 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 Sleeprelated 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	—

Measure

Time 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 Sleeprelated 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

Measure	Time frame
Cognitive and behavioural parameters: o ICU delirium by CAMICU o ICU delirium manifestation type defined by RASSscores65 (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	—

Measure

Time frame

Cognitive and behavioural parameters: o ICU delirium by CAMICU o ICU delirium manifestation type defined by RASSscores65 (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

—

Contacts

Public ContactL. Reinke

Department of Critical Care - University Medical Center Groningen

Email: l.reinke@umcg.nlTel: + 31 50 361 2327

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)