Objective: In this pilot study experience will be obtained in the simultaneous use of PSG, melatonin assay, CBT-measurement and assessment in ICU patients.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameters will be the total
sleep time (TST), percentage of TST spent in Rapid Eye Movement (REM) sleep,
percentage of TST spent in stage 1-2 and stage 3-4 Non REM sleep, the number of
awakenings and the number of arousals.
Secondary outcome
Best fit coefficients of circadian rhythm models are compared between melatonin
assay and CBT. Incidence of delirium is determined through the Confusion
Assessment Method for the ICU (CAM-ICU) observation scale.
Background summary
Rationale: Sleep deprivation is known to lead to several clinical and
physiologic manifestations also found in delirium; however, its role in the
development of delirium in the intensive care unit (ICU) is controversial.
Delirium in the ICU is among others associated with sleep deprivation, quality
of sleep and perhaps caused by a disrupted circadian rhythm.
This circadian rhythm is normally found in many physiological processes in
healthy individuals and can be easily determined by measurement of core body
temperature (CBT) following a 24-hours cycle and melatonin levels. In ICU
patients this rhythm is known to be disturbed or even abolished.1-4 It is
important to know if or to what extend the sleep of the patients at the
intensive care is affected or adversely influenced, and if this is of influence
on the incidence of delirium. Future interventional studies will focus on
methods to improve circadian rhythm to minimize sleep deprivation and incidence
of delirium.
First the feasibility of the proposed method of quantifying and
qualifying sleep through polysomnography (PSG) and simultaneously determining
circadian rhythm through blood melatonin assay and CBT-measurement, needs to be
investigated in a pilot study.
Study objective
Objective: In this pilot study experience will be obtained in the simultaneous
use of PSG, melatonin assay, CBT-measurement and assessment in ICU patients.
Study design
Study design: Prospective observational study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: No known risk is involved in participation.
Patients will receive standard intensive care with added non-invasive PSG.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Non-surgical ICU patients.
Expected duration of ICU-stay > 24 hours.
Written informed consent given by the patient according to the regulations.
Exclusion criteria
Life expectancy of < 48 hours on ICU admission
Necessity of prolonged deep sedation, > 72 hours
Blindness or severe visual impairment
Known or proven neuropathology
<18 years of age.
Patients who are incapable of giving informed consent
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 | NL40705.042.12 |