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

Primary Purpose

Delirium Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polysomnography
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Delirium Symptoms focused on measuring Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Polysomnography

    Arm Description

    Outcomes

    Primary Outcome Measures

    significant difference of REM sleep quantity in polysomnography at day 3

    Secondary Outcome Measures

    Full Information

    First Posted
    July 16, 2015
    Last Updated
    October 10, 2016
    Sponsor
    Poitiers University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02801318
    Brief Title
    Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poitiers University Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium Symptoms
    Keywords
    Patient

    7. Study Design

    Study Phase
    Not Applicable
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Polysomnography
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Polysomnography
    Primary Outcome Measure Information:
    Title
    significant difference of REM sleep quantity in polysomnography at day 3
    Time Frame
    Day 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Solène QUENTIN-PALOS, PH
    Phone
    0549443159

    12. IPD Sharing Statement

    Learn more about this trial

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

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