Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681043
|Department of Anaesthesia and Intensive Care, Vejle Hospital|
|Vejle, Denmark, 7100|