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…
ID
Source
Brief title
Condition
- Other condition
- Sleep disturbances (incl subtypes)
Synonym
Health condition
verstoorde secretie van melatonine
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
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.
Study objective
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 burden and risks
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.
HTC 34
Eindhoven 5656AE
NL
HTC 34
Eindhoven 5656AE
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52427.042.15 |