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Sleep ICU healthy subjects


- candidate number25456
- NTR NumberNTR6189
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2016
- Secondary IDsMETc 2016/468 
- Public TitleSleep ICU healthy subjects
- Scientific TitleContribution of the intensive care unit environment to sleep disruption in healthy subjects.
- ACRONYM
- hypothesisEnvironmental disturbances during ICU submission may explain observed EEG-arousals
- Healt Condition(s) or Problem(s) studiedSleep quality
- Inclusion criteriaHealthy volunteers (nurses/dosctors(in training)) currently not employed on the ICU
Age ≥ 18 years
Capable of understanding and speaking Dutch
Normal hearing
- Exclusion criteriaPre-existing history or treatment of sleep pathology
Sleep promoting medication
Alcohol addiction or illicit drug abuse
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate1-mrt-2017
- Target number of participants10
- InterventionsThe sleep quantity and quality of the subjects will be measured during 3 nights using polysomnography. Subjects will sleep 1 night at home, 1 night in a closed section of the ICU and 1 night in the active ICU.
- Primary outcomeSleep related parameters: number of arousals and awakenings per hour, total sleep time, sleep efficiency, sleep continuity
- Secondary outcomeEnvironmental parameters: sound levels, reverberation time, light levels, light frequencies, temperature
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc L. Reinke
- CONTACT for SCIENTIFIC QUERIESMSc L. Reinke
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), RijksUniversiteit Groningen, Philips Research Eindhoven
- Publications
- Brief summaryPatients admitted to an intensive care unit (ICU) are exposed to several intrinsic and extrinsic sleep disruptive factors, causing disturbed sleep, which may have detrimental effects on patient cognition and behavior. Because so many factors play a role, studying the primary effects of the busy ICU environment is complicated in patients and can therefore best be done in healthy volunteers.
Little is known about the importance of individual intrinsic and extrinsic factors on sleep in the ICU. This study will investigate the role of sound, light, and the inherent experience of the ICU environment on the incidence of arousals, and therefore the continuity of sleep. Focusing on the study of healthy subjects eliminates confounding and immeasurable intrinsic factors present in patients, that may interfere with clear analysis of this relation.
- Main changes (audit trail)
- RECORD26-okt-2016 - 19-feb-2017


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