<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/NCT03291626</url>
  </required_header>
  <id_info>
    <org_study_id>201705018</org_study_id>
    <nct_id>NCT03291626</nct_id>
  </id_info>
  <brief_title>Postoperative Delirium: EEG Markers of Sleep and Wakefulness</brief_title>
  <official_title>Postoperative Delirium: EEG Markers of Sleep and Wakefulness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      Postoperative delirium is a condition in which patients develop temporary difficulties in&#xD;
      maintaining attention and thinking clearly. These new problems can appear after surgery and&#xD;
      change throughout the day. This confusion can last several days.&#xD;
&#xD;
      The overall purpose of this study is to measure brain activity during sleep and wakefulness&#xD;
      to learn about their relationships to delirium after surgery. While participants may not feel&#xD;
      like their normal self during the study, they are in the best position to help us learn how&#xD;
      to improve the recovery of brain function and sleep in others having surgery. The&#xD;
      investigators need to learn from those who have and have not become confused after their&#xD;
      surgical procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative delirium is a condition that can develop in some older patients after they have&#xD;
      surgery and receive general anesthesia. Patients that develop delirium have difficulty&#xD;
      maintaining attention and thinking clearly. Both of these issues can come and go throughout&#xD;
      the day. The incidence of postoperative delirium is greater than 25% and is associated with&#xD;
      longer hospitalization and increased risk of persistent mental and physical decline. It is&#xD;
      thought that this disorder may be preventable, but there is no agreed upon way of identifying&#xD;
      which patients are at risk for delirium prior to their surgery. Additionally, patients with&#xD;
      atypical delirium are often misdiagnosed or undiagnosed postoperatively.&#xD;
&#xD;
      Based on previous research, the researchers have hypothesized that delirium may be directly&#xD;
      related to wakefulness and sleep problems, as shown on electroencephalography [EEG]. EEG is a&#xD;
      test that records the electrical activity of brain through placement of small wires on a&#xD;
      person's scalp. In light of this, the purpose of this study is to evaluate sleep and&#xD;
      wakefulness using EEG before, during and after surgery in order to discover any abnormalities&#xD;
      of sleep or wakefulness that associate with postoperative delirium onset, severity, and&#xD;
      length of recovery. Subjects in this study will have preoperative at home sleep testing&#xD;
      performed, using a device called the Sleep Profiler, and questionnaires administered to&#xD;
      characterize their mental function and brain function prior to surgery. When they arrive for&#xD;
      their scheduled surgery, the subjects will be fitted with the Sleep Profiler to record brain&#xD;
      activity during surgery and after surgery for 5 days. Postoperatively, the subjects will be&#xD;
      asked to do simple tasks like move toes and fingers and to answer questions that assess their&#xD;
      mental state.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 16, 2018</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">June 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>Change from pre-operative awake EEG measurement to sleep EEG measurement</measure>
    <time_frame>Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital</time_frame>
    <description>Awake EEG recorded at baseline, sleep EEG using Sleep Profiler</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline diagnosis of delirium to hospital discharge</measure>
    <time_frame>Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.</time_frame>
    <description>Delirium diagnosed using the validated instrument Confusion Assessment Method, Long Form</description>
  </primary_outcome>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Postoperative Delirium</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Potential participants recruited from the Barnes Jewish Hospital in St. Louis receiving&#xD;
        elective cardiac or major thoracic surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. English speaking&#xD;
&#xD;
          2. Age 60 or older&#xD;
&#xD;
          3. Scheduled for cardiac surgery requiring cardiopulmonary bypass for coronary artery&#xD;
             bypass grafting and/or heart valve repair/replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-existing delirium or dementia&#xD;
&#xD;
          2. Legal blindness or severe deafness&#xD;
&#xD;
          3. Surgery requiring deep hypothermic circulatory rest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ben Palanca, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University in St Louis SOM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ben J.A. Palanca</investigator_full_name>
    <investigator_title>Assoc Prof of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be shared with the National Sleep Research Resource within three years after completion of the study. We will register our observational study on clinicaltrials.gov and publish a protocol of our approach and pre-specified analyses by the end of Year 2 of funding.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be made available within 3 years of study completion and publication and will be available indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Permission from the principal investigator is required for access.</ipd_access_criteria>
    <ipd_url>https://sleepdata.org/</ipd_url>
  </patient_data>
  <!-- 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/NCT03291626
org study id: 201705018
nct id: NCT03291626
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative delirium is a condition in which patients develop temporary difficulties in
      maintaining attention and thinking clearly. These new problems can appear after surgery and
      change throughout the day. This confusion can last several days.

      The overall purpose of this study is to measure brain activity during sleep and wakefulness
      to learn about their relationships to delirium after surgery. While participants may not feel
      like their normal self during the study, they are in the best position to help us learn how
      to improve the recovery of brain function and sleep in others having surgery. The
      investigators need to learn from those who have and have not become confused after their
      surgical procedure.
Postoperative delirium is a condition that can develop in some older patients after they have
      surgery and receive general anesthesia. Patients that develop delirium have difficulty
      maintaining attention and thinking clearly. Both of these issues can come and go throughout
      the day. The incidence of postoperative delirium is greater than 25% and is associated with
      longer hospitalization and increased risk of persistent mental and physical decline. It is
      thought that this disorder may be preventable, but there is no agreed upon way of identifying
      which patients are at risk for delirium prior to their surgery. Additionally, patients with
      atypical delirium are often misdiagnosed or undiagnosed postoperatively.

      Based on previous research, the researchers have hypothesized that delirium may be directly
      related to wakefulness and sleep problems, as shown on electroencephalography [EEG]. EEG is a
      test that records the electrical activity of brain through placement of small wires on a
      person's scalp. In light of this, the purpose of this study is to evaluate sleep and
      wakefulness using EEG before, during and after surgery in order to discover any abnormalities
      of sleep or wakefulness that associate with postoperative delirium onset, severity, and
      length of recovery. Subjects in this study will have preoperative at home sleep testing
      performed, using a device called the Sleep Profiler, and questionnaires administered to
      characterize their mental function and brain function prior to surgery. When they arrive for
      their scheduled surgery, the subjects will be fitted with the Sleep Profiler to record brain
      activity during surgery and after surgery for 5 days. Postoperatively, the subjects will be
      asked to do simple tasks like move toes and fingers and to answer questions that assess their
      mental state.
observational model: Cohort
time perspective: Prospective
measure: Change from pre-operative awake EEG measurement to sleep EEG measurement
time frame: Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital
description: Awake EEG recorded at baseline, sleep EEG using Sleep Profiler
measure: Change in baseline diagnosis of delirium to hospital discharge
time frame: Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.
description: Delirium diagnosed using the validated instrument Confusion Assessment Method, Long Form
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Ben Palanca, MD, PhD
role: Principal Investigator
affiliation: Washington University in St Louis SOM
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Ben J.A. Palanca
investigator title: Assoc Prof of Anesthesiology
mesh term: Delirium
mesh term: Emergence Delirium
sharing ipd: Yes
ipd description: The data will be shared with the National Sleep Research Resource within three years after completion of the study. We will register our observational study on clinicaltrials.gov and publish a protocol of our approach and pre-specified analyses by the end of Year 2 of funding.
ipd info type: Study Protocol
ipd time frame: Data will be made available within 3 years of study completion and publication and will be available indefinitely.
ipd access criteria: Permission from the principal investigator is required for access.
ipd url: https://sleepdata.org/