An interventional study of protocol 'Quiet in the room' in Sleep, sponsored by Vejle Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Vejle Hospital · Not applicable, Interventional, and Prevention
Sleep investigation in respirator treated ICU patients: the importance of intensive environment.
Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.
The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.
Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.
Vejle Hospital is the lead sponsor of 93 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 hour PSG in 46 patients under ordinary (routine) conditions
24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
Behavioral: protocol 'Quiet in the room'
Protocol 'Quite in the room' between 10 p.m. and 6 a.m. * nurse nearby * no visits after 10 p.m. * decreased alarm sound in ventilator and monitor * decreased light intensity * no unnecessary conversations around the patient * medication should be limited to max 1-2 times in this time period * no unnecessary therapeutic or diagnostic procedures in this time period * earplugs and sleep masks
the number of arousals
arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
Time frame: per hour of sleep
total sleep time
total sleep time during 24 hour period
Time frame: 24 hours
N1 sleep
N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
Time frame: 24 hours
N2 sleep
N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
Time frame: 24 hours
N3 sleep
N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
Time frame: 24 hours
REM sleep
REM sleep will be scored during sleep periods and the percent of REM sleep will be counted
Time frame: 24 hours
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Vejle Hospital