<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/NCT02997839</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092868</org_study_id>
    <nct_id>NCT02997839</nct_id>
  </id_info>
  <brief_title>Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit</brief_title>
  <acronym>SDPPNCU</acronym>
  <official_title>Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The role of sleep in patients admitted to the intensive care unit is an emerging field of&#xD;
      research. There have been studies that show patients in the ICU have poor sleep including&#xD;
      sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2,&#xD;
      3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and&#xD;
      frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive&#xD;
      function and delirium, but there are also implications for the immune system function and&#xD;
      wound healing (4). Polysomnography is regarded as the gold standard for sleep studies,&#xD;
      however it has limited utility in the ICU population (5) and alternative methods of sleep&#xD;
      analysis need to be investigated to better understand the underlying physiologic mechanisms&#xD;
      and subsequent cognitive effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The importance of sleep for patients in the intensive care unit (ICU) has been well&#xD;
      documented. Research has shown that the ICU has multiple risk factors for poor sleep, and&#xD;
      that this has multiple effects on patient outcomes. Further research is needed to better&#xD;
      define the best tool to use for measuring sleep stages in ICU patients. Furthermore, there is&#xD;
      very limited data comparing sleep interruption in ICU patients and the effects on sleep&#xD;
      architecture and cognition.&#xD;
&#xD;
      Hypothesis 1a: The number of episodes of rapid eye movements (REM), stage 1, stage 2, stage 3&#xD;
      sleep, sleep spindles, and alpha activity will increase while the total duration of activity&#xD;
      and the duration of episodes will decline in the postoperative neurologic critical care unit&#xD;
      (NCCU) with neurological checks every two hours over a 12 hour period of recording as&#xD;
      compared to every 6 hours.&#xD;
&#xD;
      Hypothesis 1b: As the number of episodes of REM, stage 1, stage 2, stage 3 sleep, sleep&#xD;
      spindles, and alpha activity increase while the total duration of activity and the duration&#xD;
      of episodes decline in the postoperative NCCU with neurological checks every two hours over a&#xD;
      12 hour period of recording as compared to every 6 hours.&#xD;
&#xD;
      Hypothesis 2: The number of episodes, the total duration, and the interval durations, of REM,&#xD;
      stage 1, stage 2, stage 3 sleep, sleep spindles, and alpha activity will be identical in the&#xD;
      automated recordings as compared to human reading by a sleep trained Neurologist.&#xD;
&#xD;
      Hypothesis 3: The group with awakenings every two hours will report more objective sleepiness&#xD;
      and perform psychomotor visual task (PVT) with increased time and reduced performance.&#xD;
&#xD;
      Performing this study will allow for validation of an automated EEG system for the&#xD;
      interpretation of sleep. If this tool is a reliable method of sleep interpretation, it may be&#xD;
      expanded to a larger population of ICU patients for further research on the effects of sleep&#xD;
      deprivation. Additionally, it will add prospective data to the literature regarding the&#xD;
      psychomotor effects of increased sleep interruption in ICU patients.&#xD;
&#xD;
      2. Objectives (include all primary and secondary objectives)&#xD;
&#xD;
        1. Detect the effects of disrupted sleep resulting from frequent neurological exams in the&#xD;
           NCCU in post-surgical patients. The investigators will use an automated EEG detection&#xD;
           system used in patients with continuous EEG (cEEG) monitoring to detect duration of&#xD;
           sleep related EEG brain activity, number of intervals of activation, and the duration of&#xD;
           the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep,&#xD;
           sleep spindles, and alpha activity.&#xD;
&#xD;
        2. The investigators will study the precision, accuracy and bias of the automated algorithm&#xD;
           by comparing it to the interpretations of two sleep trained neurologists who will read&#xD;
           these recordings in a&#xD;
&#xD;
           blinded manner independently of one another. The investigators will select records to&#xD;
           validate the automatic scorer including the identification and duration of all aspects&#xD;
           of the cEEG sleep recording during the first four hours of sleep recording for each&#xD;
           patient. The investigators will compare the accuracy of identification and measured&#xD;
           duration of REM, Stage one, stage two, stage 3 sleep, sleep spindles, and alpha&#xD;
           activity.&#xD;
&#xD;
        3. Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire&#xD;
           (RCSG).&#xD;
&#xD;
        4. Quantitative assessment of alertness using a psychomotor vigilance task (PVT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change in design to observational study&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 26, 2018</completion_date>
  <primary_completion_date type="Actual">March 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detect the effects of disrupted sleep with quantitative EEG analysis</measure>
    <time_frame>Up to 12 hours</time_frame>
    <description>The investigators will use an automated EEG detection system used in patients with continuous EEG (cEEG) monitoring to detect duration of sleep related EEG brain activity, number of intervals of activation, and the duration of the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep, sleep spindles, and alpha activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>Two sleep trained neurologists will read these recordings in a blinded manner independently of one another. The investigators will select records to validate the automatic scorer including the identification and duration of all aspects of the cEEG sleep recording during the first four hours of sleep recording for each patient. The investigators will compare the accuracy of identification and measured duration of REM, Stage one, stage two, stage 3 sleep, sleep spindles, and alpha activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire</measure>
    <time_frame>Up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative assessment of alertness using a psychomotor vigilance task (PVT).</measure>
    <time_frame>Up to 12 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Sleep Fragmentation</condition>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>sleep disruption</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sleep disruption</intervention_name>
    <description>Group two will have interrupted sleep at time periods of 2 hours post operatively.&#xD;
Group two will be woken every 2 hours, which is the standard NCCU protocol.</description>
    <arm_group_label>group 1</arm_group_label>
    <other_name>group 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post operative back patients in the NCCU with no history of brain injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A Nyquist, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins school of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 2, 2018</last_update_submitted>
  <last_update_submitted_qc>April 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02997839
org study id: IRB00092868
nct id: NCT02997839
lead sponsor: 
has dmc: No
The role of sleep in patients admitted to the intensive care unit is an emerging field of
      research. There have been studies that show patients in the ICU have poor sleep including
      sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2,
      3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and
      frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive
      function and delirium, but there are also implications for the immune system function and
      wound healing (4). Polysomnography is regarded as the gold standard for sleep studies,
      however it has limited utility in the ICU population (5) and alternative methods of sleep
      analysis need to be investigated to better understand the underlying physiologic mechanisms
      and subsequent cognitive effects.
The importance of sleep for patients in the intensive care unit (ICU) has been well
      documented. Research has shown that the ICU has multiple risk factors for poor sleep, and
      that this has multiple effects on patient outcomes. Further research is needed to better
      define the best tool to use for measuring sleep stages in ICU patients. Furthermore, there is
      very limited data comparing sleep interruption in ICU patients and the effects on sleep
      architecture and cognition.

      Hypothesis 1a: The number of episodes of rapid eye movements (REM), stage 1, stage 2, stage 3
      sleep, sleep spindles, and alpha activity will increase while the total duration of activity
      and the duration of episodes will decline in the postoperative neurologic critical care unit
      (NCCU) with neurological checks every two hours over a 12 hour period of recording as
      compared to every 6 hours.

      Hypothesis 1b: As the number of episodes of REM, stage 1, stage 2, stage 3 sleep, sleep
      spindles, and alpha activity increase while the total duration of activity and the duration
      of episodes decline in the postoperative NCCU with neurological checks every two hours over a
      12 hour period of recording as compared to every 6 hours.

      Hypothesis 2: The number of episodes, the total duration, and the interval durations, of REM,
      stage 1, stage 2, stage 3 sleep, sleep spindles, and alpha activity will be identical in the
      automated recordings as compared to human reading by a sleep trained Neurologist.

      Hypothesis 3: The group with awakenings every two hours will report more objective sleepiness
      and perform psychomotor visual task (PVT) with increased time and reduced performance.

      Performing this study will allow for validation of an automated EEG system for the
      interpretation of sleep. If this tool is a reliable method of sleep interpretation, it may be
      expanded to a larger population of ICU patients for further research on the effects of sleep
      deprivation. Additionally, it will add prospective data to the literature regarding the
      psychomotor effects of increased sleep interruption in ICU patients.

      2. Objectives (include all primary and secondary objectives)

        1. Detect the effects of disrupted sleep resulting from frequent neurological exams in the
           NCCU in post-surgical patients. The investigators will use an automated EEG detection
           system used in patients with continuous EEG (cEEG) monitoring to detect duration of
           sleep related EEG brain activity, number of intervals of activation, and the duration of
           the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep,
           sleep spindles, and alpha activity.

        2. The investigators will study the precision, accuracy and bias of the automated algorithm
           by comparing it to the interpretations of two sleep trained neurologists who will read
           these recordings in a

           blinded manner independently of one another. The investigators will select records to
           validate the automatic scorer including the identification and duration of all aspects
           of the cEEG sleep recording during the first four hours of sleep recording for each
           patient. The investigators will compare the accuracy of identification and measured
           duration of REM, Stage one, stage two, stage 3 sleep, sleep spindles, and alpha
           activity.

        3. Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
           (RCSG).

        4. Quantitative assessment of alertness using a psychomotor vigilance task (PVT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Detect the effects of disrupted sleep with quantitative EEG analysis
time frame: Up to 12 hours
description: The investigators will use an automated EEG detection system used in patients with continuous EEG (cEEG) monitoring to detect duration of sleep related EEG brain activity, number of intervals of activation, and the duration of the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep, sleep spindles, and alpha activity.
measure: Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists
time frame: Up to 4 hours
description: Two sleep trained neurologists will read these recordings in a blinded manner independently of one another. The investigators will select records to validate the automatic scorer including the identification and duration of all aspects of the cEEG sleep recording during the first four hours of sleep recording for each patient. The investigators will compare the accuracy of identification and measured duration of REM, Stage one, stage two, stage 3 sleep, sleep spindles, and alpha activity.
measure: Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire
time frame: Up to 12 hours
measure: Quantitative assessment of alertness using a psychomotor vigilance task (PVT).
time frame: Up to 12 hours
arm group label: group 2
arm group type: No Intervention
description: no intervention
arm group label: group 1
arm group type: Other
description: sleep disruption
intervention type: Behavioral
intervention name: sleep disruption
description: Group two will have interrupted sleep at time periods of 2 hours post operatively.
Group two will be woken every 2 hours, which is the standard NCCU protocol.
arm group label: group 1
other name: group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul A Nyquist, MD
role: Principal Investigator
affiliation: Johns Hopkins school of medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Deprivation
sharing ipd: No