<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481347</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200037</org_study_id>
    <secondary_id>2019-A03206-51</secondary_id>
    <nct_id>NCT04481347</nct_id>
  </id_info>
  <brief_title>Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction</brief_title>
  <acronym>SOMEDYSPO</acronym>
  <official_title>Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM UMR-942, Paris, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LMS Ecole polytechnique and M3DISIM, Inria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The challenge of new recommendations and better adapted practices is pushing to operate&#xD;
      patients who are getting older and more fragile. In this context, there is an inevitable&#xD;
      increase in the risks associated with care and in particular perioperative neurological&#xD;
      complications, of which postoperative cognitive dysfunction (POCD) is the most common.&#xD;
&#xD;
      The interest of perioperative cerebral monitoring and in particular electroencephalography&#xD;
      (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant&#xD;
      research and corresponds to a crucial issue.&#xD;
&#xD;
      From the literature and preliminary results obtained in our clinical research unit, it&#xD;
      appears that there is also a relationship between certain characteristics of the peroperative&#xD;
      EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive&#xD;
      dysfunction (PCOD).&#xD;
&#xD;
      In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained&#xD;
      during general anesthesia could allow the identification of a simple to use biomarker of&#xD;
      susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy&#xD;
      using EEG analysis to detect a predisposition to POCD.&#xD;
&#xD;
      The main goal of this observational clinical study is to extend the traditional use of&#xD;
      per-operative EEG with pre-operative and post-operative sleep EEG for the detection and&#xD;
      prediction of early post-operative cognitive dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The interest of perioperative brain monitoring to reduce neurological and cognitive damage in&#xD;
      surgery has been the subject of much research and corresponds to a crucial issue.&#xD;
&#xD;
      The notion of quantitative EEG covers all the electrical signal processing techniques (fast&#xD;
      Fourier transformation, evoked potentials, EEG mapping, etc.) made possible through the&#xD;
      digitization of EEG data and the development of software to process these signals. In this&#xD;
      context, EEG-derived indices have been set up to monitor hypnosis during general anesthesia.&#xD;
      Between 0 (deep hypnosis) and 100 (awakening), the Bispectral Index (BIS) integrates in its&#xD;
      calculation the percentage of fast waves, the degree of wave synchronization and the periods&#xD;
      of EEG suppression (or &quot;Burst suppression&quot;) and allows an adaptation of the dosage of&#xD;
      anesthetic products according to its value.&#xD;
&#xD;
      Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative&#xD;
      delirium by reducing the burst suppression pattern.&#xD;
&#xD;
      Pre-operative cognitive status assessment :&#xD;
&#xD;
      The investigators observe a great delay in the means implemented to have an objective&#xD;
      evaluation of cognitive disorders in preoperative care.&#xD;
&#xD;
      One of the pitfalls of our anesthetist specialty is the lack of continuity of medical care in&#xD;
      the perioperative period.&#xD;
&#xD;
      The geriatric evaluation including a MMSE (mental mini state examination) and a MoCA&#xD;
      (Montreal cognitive assessment) is performed only occasionally.&#xD;
&#xD;
      Interest of the resting pre-operative EEG :&#xD;
&#xD;
      Sleep EEG analysis is already used in cognitive studies. Slow Wave Activity (SWA) is a&#xD;
      parameter known to be inversely correlated with chronological age and lowered more&#xD;
      significantly in the context of cognitive dysfunction.&#xD;
&#xD;
      The power of spindles or sleep spindles and particularly fast spindles have been shown to be&#xD;
      potentially predictive of poor cognitive development in patients already showing symptoms&#xD;
      (Mild Cognitive Impairment).&#xD;
&#xD;
      It is likely that per operative susceptibility to Burst suppression and the appearance of&#xD;
      postoperative cognitive dysfunction are linked to a set of per operative factors (anesthesia,&#xD;
      surgery, inflammation, pain...) but also preoperative factors (cognitive state, physiological&#xD;
      age and cerebral fragility...).&#xD;
&#xD;
      The investigators hypothesize that there is an association between preoperative resting EEG&#xD;
      abnormalities and the risk of postoperative cognitive dysfunction.&#xD;
&#xD;
      The goal of this observational clinical study is to assess the fragility of a patient under&#xD;
      general anesthesia and based on the perioperative quantitative analysis EEG. Thus, this&#xD;
      project should help specialists in perioperative medicine to identify patients at risk of&#xD;
      cognitive dysfunction and could lead to proposing strategies for its prevention.&#xD;
&#xD;
      Measures are based on neuro-psychological tests (Montreal cognitive assesment -MoCA) and EEG&#xD;
      signal and subfrequency power spectral densities including alpha band as well as the amount&#xD;
      of Propofol, each measured for EEG periods where SEF 95 = 8-13Hz.&#xD;
&#xD;
      Analysis includes the characteristics of the preoperative sleep EEG (SWA, fast spindles).&#xD;
&#xD;
      Experimental design: This is a single-center, observational prospective study.&#xD;
&#xD;
      Population concerned :&#xD;
&#xD;
      Patients eligible for interventional neuroradiology or surgery performed under General&#xD;
      Anesthesia are selected to participate in this prospective, observational, single-center,&#xD;
      routine care study. Patients will be included if they received, for a non-urgent scheduled&#xD;
      procedure.&#xD;
&#xD;
      Patients over 18 years of age are eligible to participate in this protocol. During the&#xD;
      anesthesia consultation, they will be given a hand-delivered letter of information on the&#xD;
      objectives and the course of the study. Their non-opposition to participating in this study&#xD;
      will be collected at the latest during the pre-anesthetic visit, on the eve of the operation&#xD;
      after a period of reflection.&#xD;
&#xD;
      The protocol will start the day before the intervention. The interventions will be performed&#xD;
      under general anaesthesia. The protocol does not interact with the care procedure. All the&#xD;
      measures are obtained non-invasively.&#xD;
&#xD;
      The day before the procedure: performance of a sleep EEG (DREEM®) and a MoCA test. On the day&#xD;
      of the procedure, monitoring of the depth of anesthesia using the quantitative EEG (Sedline&#xD;
      Masimo®) ensures continuous recording of intraoperative EEG data. Postoperatively the same&#xD;
      investigator performs MoCA at Day1, Day2 and Day5. A sleep EEG (DREEM®) is performed at Day2&#xD;
      and Day5 if the patient is still hospitalized.&#xD;
&#xD;
      During their general anesthesia, all patients' routine monitoring will consist in collecting&#xD;
      the following parameters: electrocardiogram, pulsated oxygen saturation, endtidal CO2,&#xD;
      respiratory rate, tidal volume and neuromuscular function.&#xD;
&#xD;
      For all patients whatever the comorbidities, anesthesia induction will be performed using a&#xD;
      target-controlled infusion (Orchestra® Base Primea - Fresenius Kabi France).&#xD;
&#xD;
      No additional additional examination will be performed. The anesthetic strategy is decided by&#xD;
      the anesthetist in charge of the procedure.&#xD;
&#xD;
      The doctor in charge of the study collecting the data does not interfere at any time in the&#xD;
      management of the patient. The measurements cannot influence the prescribing physician since&#xD;
      at this stage the data are not yet analysed and available.&#xD;
&#xD;
      Number of selected subjects: Assuming an incidence of DCPO of 30%, with power at 80% and&#xD;
      alpha risk at 5%, it is necessary to include 100 patients to demonstrate an area under the&#xD;
      ROC curve of 80% with a confidence interval width of 0.1&#xD;
&#xD;
      Statistics:&#xD;
&#xD;
      Continuous data will be expressed in median [interquartile] and qualitative data in n (%).&#xD;
      Categorical variables will be compared by Mann-Whitney test and continuous variables by&#xD;
      Wilcoxon test.&#xD;
&#xD;
      In this study, the primary endpoint was the occurrence of post-operative cognitive&#xD;
      dysfunction, defined as a decrease in MoCA score of more than 4 points between preoperative&#xD;
      and postoperative periods (worst value of the score measured at D1, D2 and D5). The main&#xD;
      exposure is the quantitative score obtained from the analysis of the pre-operative sleep EEG.&#xD;
&#xD;
      The ability of the various parameters of interest of the preoperative sleep EEG to predict&#xD;
      the occurrence of DCPO will be estimated by constructing an ROC curve. The area of these ROC&#xD;
      curves will be measured and the corresponding 95% confidence interval estimated. The areas&#xD;
      under the ROC curve of the different parameters will be compared by DeLong test. A uni- and&#xD;
      then multivariate analysis will be performed to identify the clinical parameters associated&#xD;
      with the occurrence of a DCPO. The possible added value of the sleep EEG parameters on the&#xD;
      clinical parameters will be evaluated by reclassification techniques.&#xD;
&#xD;
      The statistical analysis will be carried out using the statistical analysis software &quot;R&quot; (The&#xD;
      R Foundation, Vienna, Austria)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 2022</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Early postoperative cognitive dysfunction</measure>
    <time_frame>Change between day -1 and day 5</time_frame>
    <description>Score obtained following evaluation of the patient's cognitive function using the Montreal Cognitive Assessment questionnaire MoCA (0-30; higher score indicates better performance)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Burst suppression duration</measure>
    <time_frame>Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)</time_frame>
    <description>For all patients the values of Burst Suppression (in % of time) will be collected from frontal electrodes montage (Fp1, Fp2, F7, F8) during the total anesthesia period (induction and hypnotic periods)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in alpha power on sleep EEG</measure>
    <time_frame>Change between day -1 and day 5</time_frame>
    <description>Variations in alpha power (in Decibel, Db) on the pre-operative and post-operative sleep EEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spindle amplitude on sleep EEG</measure>
    <time_frame>Change between day -1 and day 5</time_frame>
    <description>Spindle amplitude (in Decibel, Db) on preoperative and postoperative sleep EEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spindle frequency on sleep EEG</measure>
    <time_frame>Change between day -1 and day 5</time_frame>
    <description>Spindle frequency (in Hertz, Hz) on preoperative and postoperative sleep EEG</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Patients undergoing general anesthesia</arm_group_label>
    <description>Patients eligible for interventional neuroradiology or surgery performed under general anesthesia. Patients will be included if they are admitted for a non-emergency scheduled procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sleep EEG recording using a DREEM® headband</intervention_name>
    <description>Sleep EEG recording using a Dreem® headband (Rythm, Paris, France), an EEG recording device adapted to sleep conditions and completely non-invasive</description>
    <arm_group_label>Patients undergoing general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Montreal Cognitive Assessment (MoCA)</intervention_name>
    <description>Neuropsychological assessment using the The Montreal Cognitive Assessment (MoCA) questionnaire to detect postoperative cognitive dysfunction</description>
    <arm_group_label>Patients undergoing general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraoperative EEG recording using a Sedline® monitoring</intervention_name>
    <description>Intraoperative brain function monitoring using a Sedline® module (Masimo corporation) to evaluate the state of the brain under anesthesia</description>
    <arm_group_label>Patients undergoing general anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients eligible for a non-emergency scheduled interventional neuroradiology procedure or&#xD;
        surgery performed under general anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients (≥ 18 years )&#xD;
&#xD;
          -  Eligible for an interventional radiology procedure or surgery under general anesthesia&#xD;
&#xD;
          -  Patients informed and having expressed their non-opposition to participation in this&#xD;
             research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Severe pre-existing cognitive impairment (preoperative mini-mental state examination&#xD;
             (MMSE) &lt; 24)&#xD;
&#xD;
          -  Patient opposed to protocol participation&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patient under judicial protection&#xD;
&#xD;
          -  Patient without affiliation to a social security scheme&#xD;
&#xD;
          -  Emergency procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joaquim MATEO, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabrice VALLEE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joaquim MATEO, MD</last_name>
    <phone>+33 (0)1 49 95 83 74</phone>
    <email>joaquim.mateo@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabrice VALLEE, MD</last_name>
    <phone>+33 (0)1 49 95 80 71</phone>
    <email>fabrice.vallee@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Joaquim MATEO, MD</last_name>
      <phone>+33 (0)1 49 95 83 74</phone>
      <email>joaquim.mateo@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Fabrice VALLEE, MD</last_name>
      <phone>+33 (0)1 49 95 80 71</phone>
      <email>vallee@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postoperative cognitive dysfunction</keyword>
  <keyword>depth of anesthesia</keyword>
  <keyword>brain fragility</keyword>
  <keyword>electrographic suppression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481347
org study id: APHP200037
secondary id: 2019-A03206-51
nct id: NCT04481347
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The challenge of new recommendations and better adapted practices is pushing to operate
      patients who are getting older and more fragile. In this context, there is an inevitable
      increase in the risks associated with care and in particular perioperative neurological
      complications, of which postoperative cognitive dysfunction (POCD) is the most common.

      The interest of perioperative cerebral monitoring and in particular electroencephalography
      (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant
      research and corresponds to a crucial issue.

      From the literature and preliminary results obtained in our clinical research unit, it
      appears that there is also a relationship between certain characteristics of the peroperative
      EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive
      dysfunction (PCOD).

      In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained
      during general anesthesia could allow the identification of a simple to use biomarker of
      susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy
      using EEG analysis to detect a predisposition to POCD.

      The main goal of this observational clinical study is to extend the traditional use of
      per-operative EEG with pre-operative and post-operative sleep EEG for the detection and
      prediction of early post-operative cognitive dysfunction.
The interest of perioperative brain monitoring to reduce neurological and cognitive damage in
      surgery has been the subject of much research and corresponds to a crucial issue.

      The notion of quantitative EEG covers all the electrical signal processing techniques (fast
      Fourier transformation, evoked potentials, EEG mapping, etc.) made possible through the
      digitization of EEG data and the development of software to process these signals. In this
      context, EEG-derived indices have been set up to monitor hypnosis during general anesthesia.
      Between 0 (deep hypnosis) and 100 (awakening), the Bispectral Index (BIS) integrates in its
      calculation the percentage of fast waves, the degree of wave synchronization and the periods
      of EEG suppression (or "Burst suppression") and allows an adaptation of the dosage of
      anesthetic products according to its value.

      Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative
      delirium by reducing the burst suppression pattern.

      Pre-operative cognitive status assessment :

      The investigators observe a great delay in the means implemented to have an objective
      evaluation of cognitive disorders in preoperative care.

      One of the pitfalls of our anesthetist specialty is the lack of continuity of medical care in
      the perioperative period.

      The geriatric evaluation including a MMSE (mental mini state examination) and a MoCA
      (Montreal cognitive assessment) is performed only occasionally.

      Interest of the resting pre-operative EEG :

      Sleep EEG analysis is already used in cognitive studies. Slow Wave Activity (SWA) is a
      parameter known to be inversely correlated with chronological age and lowered more
      significantly in the context of cognitive dysfunction.

      The power of spindles or sleep spindles and particularly fast spindles have been shown to be
      potentially predictive of poor cognitive development in patients already showing symptoms
      (Mild Cognitive Impairment).

      It is likely that per operative susceptibility to Burst suppression and the appearance of
      postoperative cognitive dysfunction are linked to a set of per operative factors (anesthesia,
      surgery, inflammation, pain...) but also preoperative factors (cognitive state, physiological
      age and cerebral fragility...).

      The investigators hypothesize that there is an association between preoperative resting EEG
      abnormalities and the risk of postoperative cognitive dysfunction.

      The goal of this observational clinical study is to assess the fragility of a patient under
      general anesthesia and based on the perioperative quantitative analysis EEG. Thus, this
      project should help specialists in perioperative medicine to identify patients at risk of
      cognitive dysfunction and could lead to proposing strategies for its prevention.

      Measures are based on neuro-psychological tests (Montreal cognitive assesment -MoCA) and EEG
      signal and subfrequency power spectral densities including alpha band as well as the amount
      of Propofol, each measured for EEG periods where SEF 95 = 8-13Hz.

      Analysis includes the characteristics of the preoperative sleep EEG (SWA, fast spindles).

      Experimental design: This is a single-center, observational prospective study.

      Population concerned :

      Patients eligible for interventional neuroradiology or surgery performed under General
      Anesthesia are selected to participate in this prospective, observational, single-center,
      routine care study. Patients will be included if they received, for a non-urgent scheduled
      procedure.

      Patients over 18 years of age are eligible to participate in this protocol. During the
      anesthesia consultation, they will be given a hand-delivered letter of information on the
      objectives and the course of the study. Their non-opposition to participating in this study
      will be collected at the latest during the pre-anesthetic visit, on the eve of the operation
      after a period of reflection.

      The protocol will start the day before the intervention. The interventions will be performed
      under general anaesthesia. The protocol does not interact with the care procedure. All the
      measures are obtained non-invasively.

      The day before the procedure: performance of a sleep EEG (DREEM®) and a MoCA test. On the day
      of the procedure, monitoring of the depth of anesthesia using the quantitative EEG (Sedline
      Masimo®) ensures continuous recording of intraoperative EEG data. Postoperatively the same
      investigator performs MoCA at Day1, Day2 and Day5. A sleep EEG (DREEM®) is performed at Day2
      and Day5 if the patient is still hospitalized.

      During their general anesthesia, all patients' routine monitoring will consist in collecting
      the following parameters: electrocardiogram, pulsated oxygen saturation, endtidal CO2,
      respiratory rate, tidal volume and neuromuscular function.

      For all patients whatever the comorbidities, anesthesia induction will be performed using a
      target-controlled infusion (Orchestra® Base Primea - Fresenius Kabi France).

      No additional additional examination will be performed. The anesthetic strategy is decided by
      the anesthetist in charge of the procedure.

      The doctor in charge of the study collecting the data does not interfere at any time in the
      management of the patient. The measurements cannot influence the prescribing physician since
      at this stage the data are not yet analysed and available.

      Number of selected subjects: Assuming an incidence of DCPO of 30%, with power at 80% and
      alpha risk at 5%, it is necessary to include 100 patients to demonstrate an area under the
      ROC curve of 80% with a confidence interval width of 0.1

      Statistics:

      Continuous data will be expressed in median [interquartile] and qualitative data in n (%).
      Categorical variables will be compared by Mann-Whitney test and continuous variables by
      Wilcoxon test.

      In this study, the primary endpoint was the occurrence of post-operative cognitive
      dysfunction, defined as a decrease in MoCA score of more than 4 points between preoperative
      and postoperative periods (worst value of the score measured at D1, D2 and D5). The main
      exposure is the quantitative score obtained from the analysis of the pre-operative sleep EEG.

      The ability of the various parameters of interest of the preoperative sleep EEG to predict
      the occurrence of DCPO will be estimated by constructing an ROC curve. The area of these ROC
      curves will be measured and the corresponding 95% confidence interval estimated. The areas
      under the ROC curve of the different parameters will be compared by DeLong test. A uni- and
      then multivariate analysis will be performed to identify the clinical parameters associated
      with the occurrence of a DCPO. The possible added value of the sleep EEG parameters on the
      clinical parameters will be evaluated by reclassification techniques.

      The statistical analysis will be carried out using the statistical analysis software "R" (The
      R Foundation, Vienna, Austria)
observational model: Cohort
time perspective: Prospective
measure: Early postoperative cognitive dysfunction
time frame: Change between day -1 and day 5
description: Score obtained following evaluation of the patient's cognitive function using the Montreal Cognitive Assessment questionnaire MoCA (0-30; higher score indicates better performance)
measure: Burst suppression duration
time frame: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)
description: For all patients the values of Burst Suppression (in % of time) will be collected from frontal electrodes montage (Fp1, Fp2, F7, F8) during the total anesthesia period (induction and hypnotic periods)
measure: Variations in alpha power on sleep EEG
time frame: Change between day -1 and day 5
description: Variations in alpha power (in Decibel, Db) on the pre-operative and post-operative sleep EEG
measure: Spindle amplitude on sleep EEG
time frame: Change between day -1 and day 5
description: Spindle amplitude (in Decibel, Db) on preoperative and postoperative sleep EEG
measure: Spindle frequency on sleep EEG
time frame: Change between day -1 and day 5
description: Spindle frequency (in Hertz, Hz) on preoperative and postoperative sleep EEG
arm group label: Patients undergoing general anesthesia
description: Patients eligible for interventional neuroradiology or surgery performed under general anesthesia. Patients will be included if they are admitted for a non-emergency scheduled procedure.
intervention type: Device
intervention name: Sleep EEG recording using a DREEM® headband
description: Sleep EEG recording using a Dreem® headband (Rythm, Paris, France), an EEG recording device adapted to sleep conditions and completely non-invasive
arm group label: Patients undergoing general anesthesia
intervention type: Other
intervention name: Montreal Cognitive Assessment (MoCA)
description: Neuropsychological assessment using the The Montreal Cognitive Assessment (MoCA) questionnaire to detect postoperative cognitive dysfunction
arm group label: Patients undergoing general anesthesia
intervention type: Device
intervention name: Intraoperative EEG recording using a Sedline® monitoring
description: Intraoperative brain function monitoring using a Sedline® module (Masimo corporation) to evaluate the state of the brain under anesthesia
arm group label: Patients undergoing general anesthesia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joaquim MATEO, MD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Fabrice VALLEE, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Joaquim MATEO, MD
phone: +33 (0)1 49 95 83 74
email: joaquim.mateo@aphp.fr
last name: Fabrice VALLEE, MD
phone: +33 (0)1 49 95 80 71
email: fabrice.vallee@gmail.com
facility: 
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction