Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery

October 10, 2016 updated by: Poitiers University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Polysomnography
Procedure: Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
significant difference of REM sleep quantity in polysomnography at day 3
Time Frame: Day 3
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

June 14, 2016

First Posted (ESTIMATE)

June 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELI-SLEEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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