Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
|ClinicalTrials.gov Identifier: NCT01681043|
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Behavioral: protocol 'Quiet in the room'||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
No Intervention: 24 hour PSG under ordinary conditions
24 hour PSG in 46 patients under ordinary (routine) conditions
Active Comparator: 24 hours PSG under protocol 'Quiet in the room'
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.
- the number of arousals [ Time Frame: per hour of sleep ]arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
- total sleep time [ Time Frame: 24 hours ]total sleep time during 24 hour period
- N1 sleep [ Time Frame: 24 hours ]N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
- N2 sleep [ Time Frame: 24 hours ]N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
- N3 sleep [ Time Frame: 24 hours ]N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
- REM sleep [ Time Frame: 24 hours ]REM sleep will be scored during sleep periods and the percent of REM sleep will be counted
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681043
|Department of Anaesthesia and Intensive Care, Vejle Hospital|
|Vejle, Denmark, 7100|