Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedOctober 12, 2016
October 1, 2016
July 16, 2015
October 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
significant difference of REM sleep quantity in polysomnography at day 3
Day 3
Study Arms (1)
Polysomnography
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients who had a cardiac surgery with extracorporeal circulation.
- Patients who were extubated at Day 0.
- Patients without any operation or anesthetic complication.
- Patients who speak French.
- Patients without TNC at Day 1.
- Patients who had completed the questionnaires before operation.
You may not qualify if:
- Age \< 18 years old.
- Delirium at Day 1.
- Central nervous system pathology or psychiatric pathology known and treated.
- Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep.
- Clinical condition alteration before polysomnography exam.
- Continue sedation required before Day 3 polysomnography exam.
- Agitation or clinical alteration that did not allow Day 3 polysomnography exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2015
First Posted
June 15, 2016
Primary Completion
March 1, 2018
Last Updated
October 12, 2016
Record last verified: 2016-10