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Sleep and biorhythm in the ICU


- candidate number22534
- NTR NumberNTR5345
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2015
- Secondary IDsMETC 2015.134 ABR NL52427.042.15
- Public TitleSleep and biorhythm in the ICU
- Scientific TitleSleep and biorhythm in ICU patients: a pilot study
- ACRONYMSleep-ICU
- hypothesisMetabolic disturbances associated with critical illness may disturb secretion of melatonin, the most important factor for circadian timekeeping. This disturbance may in turn hamper distribution and high quality sleep, with potentially detrimental effects on patient cognition and behaviour.
- Healt Condition(s) or Problem(s) studiedMelatonin, Sleep quality, Delirium
- Inclusion criteriaICU 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 criteriaPreexisting 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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-jul-2016
- Target number of participants50
- Interventions- none
- Primary outcomeCorrelation between sleep continuity and amplitude of melatonin secretion
Interrater agreement between methods of sleep analysis (defined by Cohenís 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 outcomeCognitive 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
- Timepoints24 hours after admission to the ICU, with a maximum inclusion duration of 72 hours.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc L. Reinke
- CONTACT for SCIENTIFIC QUERIESMSc L. Reinke
- Sponsor/Initiator University Medical Center Groningen (UMCG), Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Philips Research Eindhoven
- PublicationsReinke, 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).
- Brief summaryBackground of the study:
Metabolic disturbances associated with critical illness may disturb secretion of melatonin, the most important factor for circadian timekeeping. This disturbance may in turn hamper distribution and high quality sleep, with potentially detrimental effects on patient cognition and behaviour.
Objective of the study:
To investigate the incidence and severity of disturbed biorhythm among ICU patients, and the effect on quality of sleep. We also aim to validate the novel ICU Depth Of Sleep (IDOS) index in detecting depth of sleep over time. Secondarily: we will determine the incidence, duration and severity of disturbed sleep and delirium among ICU patients.
Study design:
Prospective observational pilot study
Study population:
50 adult ICU patients with an expected stay of >48 hours in the ICU of the UMCG.
Primary study parameters/outcome of the study: Correlation between sleep continuity and amplitude of melatonin secretion
Interrater agreement between methods of sleep analysis (defined by Cohenís 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
Secundary study parameters/outcome of the study (if applicable):
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
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
There is no foreseeable risk involved with participation in this observational pilot study. The greater majority of ICU patients undergo frequent blood withdrawal from indwelling catheters for routine measurements. Participation in this study will marginally increase the total amount of blood taken, while also utilizing irregularly sampled blood from routine measurements. This additional material provides more data without increasing the burden on ICU patients.
- Main changes (audit trail)
- RECORD4-aug-2015 - 25-aug-2015


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