xml: <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/NCT05963672</url>
    </required_header>
    <id_info>
      <org_study_id>SleepScan</org_study_id>
      <nct_id>NCT05963672</nct_id>
    </id_info>
    <brief_title>Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit</brief_title>
    <acronym>SleepScan</acronym>
    <official_title>Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Poitiers University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Poitiers University Hospital</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>
        Sleep of critically ill patients is highly disturbed with a high sleep fragmentation;&#xD;
        patients spend most of their sleep in very short sleep episodes, lasting less than 10&#xD;
        minutes. Causes of theses sleep alterations are complex including environmental noise&#xD;
        (alarms, beepers, conversations…), continuous light, nurse care and repetitive measures of&#xD;
        vital parameters.&#xD;
  &#xD;
        Numerous studies have reported a relationship between severe sleep alterations and a&#xD;
        prolonged weaning period and mortality. Improving sleep quality in critically ill patients is&#xD;
        a major challenge to promote ICU patient's recovery.&#xD;
  &#xD;
        A very promising treatment is the application of a nocturnal &quot; quiet-time &quot; during which non&#xD;
        urgent care, comfort care, systematic measures of vital parameters are delayed and clustered&#xD;
        in order to limit room entries. However, &quot; quiet time &quot; procedures have failed to improve&#xD;
        sleep quality to date.&#xD;
  &#xD;
        A miniaturized medical device recording one EEG channel and embedding an automated sleep&#xD;
        scoring algorithm running in real-time was devised. This device (positioned on forehead, and&#xD;
        continuously recording noise and light levels) indicates if the patient is awake or asleep&#xD;
        using a tablet positioned at doorstep of the room, so that nurses know if patient is&#xD;
        sleeping, without entering the room.&#xD;
  &#xD;
        Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting&#xD;
        room entries, reducing lights and noise, delaying non urgent care…) when patients are&#xD;
        sleeping (= EEG-guided strategies) will increase patients sleep quality.&#xD;
  &#xD;
        This study will assess the effect of such device on sleep quality in ICU patients. This is a&#xD;
        &quot;before / after&quot; design. The first group (&quot;control group&quot;), will be recorded but the sleep&#xD;
        scoring will not be displayed by the tablet and patient will be expose to standard care.&#xD;
        Then, procedure will be established collegially with nurses, nurses assistants and doctors.&#xD;
        Then, the second group (&quot;treated group&quot;) will be recorded with the device displaying the&#xD;
        status of the patient (asleep/awake) and all caregivers will be asked to follow the&#xD;
        established rules (&quot;EEG-guided sleep protection rules&quot;)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">August 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 23, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>Day 1</time_frame>
      <description>Proportion of continuous sleep</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep fragmentation</measure>
      <time_frame>Day 1</time_frame>
      <description>Number of arousals and awakenings per hour of sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Environmental noise and environmental light</measure>
      <time_frame>Day 1 to Day 4</time_frame>
      <description>Number of peak noise end time spent above 20 lux</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep interruptions by caregivers</measure>
      <time_frame>Day 1 to Day 4</time_frame>
      <description>Number of room entries while patient is asleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>Day 2 to Day 4</time_frame>
      <description>Proportion of continuous sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Workload assessed by nurses</measure>
      <time_frame>Day 1 to Day 4</time_frame>
      <description>Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Agitation</measure>
      <time_frame>Day 1 to day 4</time_frame>
      <description>Number of patients with diminishing (-1 point) Richmond Agitation-Sedation Scale (RASS) score. 10 Agitation-Sedation scale items From +4 (combative) to -5 (non-recoverable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance of the algorithm</measure>
      <time_frame>Day 1</time_frame>
      <description>Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported sleep quality</measure>
      <time_frame>Day 1 to day 4</time_frame>
      <description>Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety level</measure>
      <time_frame>Day 1 to day 4</time_frame>
      <description>Score at Spielberger Y-A scale.It consist of 12 questions, each rated on a scale with 4 response options. Lower score means a minimal anxiety level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory status</measure>
      <time_frame>At Unit care discharge, an average of 14 days</time_frame>
      <description>Weaning duration (number of days), ventilator free days and respiratory status at discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of delirium</measure>
      <time_frame>Day 1 to Day 4</time_frame>
      <description>Number of days with positive Confusion Assessment Method(CAM)-ICU scale. It is made up of 4 criteria. The test is POSITIVE (confusion present) if 1 and 2 + 3 or 4 are met.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unit Care length of stay</measure>
      <time_frame>At Unit care discharge, an average of 14 days</time_frame>
      <description>Number of days in ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the procedure</measure>
      <time_frame>One day after Unit Care discharge, an average of 15 days</time_frame>
      <description>Numbers of Serious adverse events and Material defect events</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep Quality</condition>
    <condition>Critically Ill Patient</condition>
    <condition>Intensive Care Unit</condition>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>EEG-guided sleep protection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EEG-guided sleep protection</intervention_name>
      <description>The tablet will display a specific picture &quot;prioritize sleep&quot; or &quot;prioritize care&quot; depending on the patient status determined by the algorithm. When the picture &quot;favor/prioritize sleep&quot; is displayed, all caregivers and visiting family are asked to follow the sleep protection rules: refrain to enter the room for not urgent reasons, switch off television, reduced light in the room/corridor, reduce noise in front of the door, close curtain (if any), and delay non urgent care…etc; if caregivers have to enter the room, headlight and/or additional light will be favored. All these rules will be established collegially by nurses and doctors. Obviously, urgent care and reactions to alarms are maintained.&#xD;
  When the picture &quot;favor/prioritize care&quot; is displayed, all caregivers and visiting family are invited to perform non urgent care, cleaning, restocking perfusion needles, comfort care, visiting.</description>
      <arm_group_label>EEG-guided sleep protection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control condition</intervention_name>
      <description>the recording device will be placed on the patient to record sleep but the tablet will be masked and placed face down on the bench in the room, invisible from the door.</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults admitted in medical ICU of University Hospital of Poitiers&#xD;
  &#xD;
                 -  Un-sedated patients displaying a RASS scale between -2 and +1&#xD;
  &#xD;
                 -  Intubated or spontaneously breathing patients&#xD;
  &#xD;
                 -  Patient or family have signed the inform consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a central nervous system disease altering sleep scoring&#xD;
  &#xD;
            -  Patients who received drugs (&lt;24h) modifying significantly EEG and sleep scoring&#xD;
  &#xD;
            -  Patients with cutaneous erosion of the scalp&#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_contact>
      <last_name>Xavier DROUOT, Pr</last_name>
      <phone>05 49 44 34 65</phone>
      <phone_ext>+33</phone_ext>
      <email>xavier.drouot@chu-poitiers.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Critical Illness</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963672
  org study id: SleepScan
  nct id: NCT05963672
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sleep of critically ill patients is highly disturbed with a high sleep fragmentation;
        patients spend most of their sleep in very short sleep episodes, lasting less than 10
        minutes. Causes of theses sleep alterations are complex including environmental noise
        (alarms, beepers, conversations…), continuous light, nurse care and repetitive measures of
        vital parameters.
  
        Numerous studies have reported a relationship between severe sleep alterations and a
        prolonged weaning period and mortality. Improving sleep quality in critically ill patients is
        a major challenge to promote ICU patient's recovery.
  
        A very promising treatment is the application of a nocturnal " quiet-time " during which non
        urgent care, comfort care, systematic measures of vital parameters are delayed and clustered
        in order to limit room entries. However, " quiet time " procedures have failed to improve
        sleep quality to date.
  
        A miniaturized medical device recording one EEG channel and embedding an automated sleep
        scoring algorithm running in real-time was devised. This device (positioned on forehead, and
        continuously recording noise and light levels) indicates if the patient is awake or asleep
        using a tablet positioned at doorstep of the room, so that nurses know if patient is
        sleeping, without entering the room.
  
        Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting
        room entries, reducing lights and noise, delaying non urgent care…) when patients are
        sleeping (= EEG-guided strategies) will increase patients sleep quality.
  
        This study will assess the effect of such device on sleep quality in ICU patients. This is a
        "before / after" design. The first group ("control group"), will be recorded but the sleep
        scoring will not be displayed by the tablet and patient will be expose to standard care.
        Then, procedure will be established collegially with nurses, nurses assistants and doctors.
        Then, the second group ("treated group") will be recorded with the device displaying the
        status of the patient (asleep/awake) and all caregivers will be asked to follow the
        established rules ("EEG-guided sleep protection rules")
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Sleep quality
  time frame: Day 1
  description: Proportion of continuous sleep
  measure: Sleep fragmentation
  time frame: Day 1
  description: Number of arousals and awakenings per hour of sleep
  measure: Environmental noise and environmental light
  time frame: Day 1 to Day 4
  description: Number of peak noise end time spent above 20 lux
  measure: Sleep interruptions by caregivers
  time frame: Day 1 to Day 4
  description: Number of room entries while patient is asleep
  measure: Sleep quality
  time frame: Day 2 to Day 4
  description: Proportion of continuous sleep
  measure: Workload assessed by nurses
  time frame: Day 1 to Day 4
  description: Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
  measure: Patient Agitation
  time frame: Day 1 to day 4
  description: Number of patients with diminishing (-1 point) Richmond Agitation-Sedation Scale (RASS) score. 10 Agitation-Sedation scale items From +4 (combative) to -5 (non-recoverable)
  measure: Performance of the algorithm
  time frame: Day 1
  description: Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
  measure: Patient reported sleep quality
  time frame: Day 1 to day 4
  description: Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep
  measure: Anxiety level
  time frame: Day 1 to day 4
  description: Score at Spielberger Y-A scale.It consist of 12 questions, each rated on a scale with 4 response options. Lower score means a minimal anxiety level.
  measure: Respiratory status
  time frame: At Unit care discharge, an average of 14 days
  description: Weaning duration (number of days), ventilator free days and respiratory status at discharge
  measure: Presence of delirium
  time frame: Day 1 to Day 4
  description: Number of days with positive Confusion Assessment Method(CAM)-ICU scale. It is made up of 4 criteria. The test is POSITIVE (confusion present) if 1 and 2 + 3 or 4 are met.
  measure: Unit Care length of stay
  time frame: At Unit care discharge, an average of 14 days
  description: Number of days in ICU
  measure: Safety of the procedure
  time frame: One day after Unit Care discharge, an average of 15 days
  description: Numbers of Serious adverse events and Material defect events
  arm group label: Usual Care
  arm group type: Sham Comparator
  arm group label: EEG-guided sleep protection
  arm group type: Experimental
  intervention type: Device
  intervention name: EEG-guided sleep protection
  description: The tablet will display a specific picture "prioritize sleep" or "prioritize care" depending on the patient status determined by the algorithm. When the picture "favor/prioritize sleep" is displayed, all caregivers and visiting family are asked to follow the sleep protection rules: refrain to enter the room for not urgent reasons, switch off television, reduced light in the room/corridor, reduce noise in front of the door, close curtain (if any), and delay non urgent care…etc; if caregivers have to enter the room, headlight and/or additional light will be favored. All these rules will be established collegially by nurses and doctors. Obviously, urgent care and reactions to alarms are maintained.
  When the picture "favor/prioritize care" is displayed, all caregivers and visiting family are invited to perform non urgent care, cleaning, restocking perfusion needles, comfort care, visiting.
  arm group label: EEG-guided sleep protection
  intervention type: Other
  intervention name: Control condition
  description: the recording device will be placed on the patient to record sleep but the tablet will be masked and placed face down on the bench in the room, invisible from the door.
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xavier DROUOT, Pr
  phone: 05 49 44 34 65
  phone ext: +33
  email: xavier.drouot@chu-poitiers.fr
  responsible party type: Sponsor
  mesh term: Critical Illness