<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/NCT01727375</url>
  </required_header>
  <id_info>
    <org_study_id>PreDeLight-ICU</org_study_id>
    <nct_id>NCT01727375</nct_id>
  </id_info>
  <brief_title>Prevention of Delirium With Light in the Intensive Care Unit</brief_title>
  <acronym>PreDeLight-ICU</acronym>
  <official_title>Prevention of Delirium With Light in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this multicenter randomised controlled trial is to investigate if circadian&#xD;
      light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces&#xD;
      prevalence of delirium in mechanically ventilated intensive care unit patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients, who are randomly assigned to the &quot;Lightening arm&quot; will have the circadian light for&#xD;
      the whole ICU stay. Light levels at the patients bedside will be measured continuously:&#xD;
      embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue&#xD;
      color bands and a white light measurement in lux&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of delirium</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
    <description>Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delirium prevalence</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
    <description>In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of delirium</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
    <description>Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of delirium</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of subsyndromal delirium (SSD)</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of anxiety</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Dysfunction</measure>
    <time_frame>ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Disorder (PTSD)</measure>
    <time_frame>6 and 12 months after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>In the night, starting 48 hours after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of sedation</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of administered opioids</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of administered benzodiazepines</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of administered sedatives</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of administered antipsychotics</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light levels (lux) Light levels (lux)</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light frequencies</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Noise levels (decibel)</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Standard light</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm patients receive standard lightening conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ciradian light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm patients receive artificial ceiling light (circadian light) at the bedside.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Circadian light</intervention_name>
    <description>Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require.&#xD;
Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.</description>
    <arm_group_label>Ciradian light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients with age 18 years and above&#xD;
&#xD;
          -  Intensive Care Unit stay ≥ 48 hours&#xD;
&#xD;
          -  Invasive mechanical ventilation or not invasive mechanical ventilation (with positive&#xD;
             ventilation pressure &gt;6hours/day and highflow &gt;30 litres) on the day of Intensive Care&#xD;
             Unit admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history Intensive Care Unit stay during the actual hospital stay&#xD;
&#xD;
          -  Patients with delirium on the day of Intensive Care Unit admission&#xD;
&#xD;
          -  Patients with psychiatric diseases&#xD;
&#xD;
          -  Patients with a history of stroke and known cognitive dysfunctions&#xD;
&#xD;
          -  Participation in other clinical studies 10 days before study inclusion and during the&#xD;
             study period&#xD;
&#xD;
          -  Psychiatric disease&#xD;
&#xD;
          -  History of stroke with known residual cognitive deficits&#xD;
&#xD;
          -  History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation&#xD;
             during entire hospital stay&#xD;
&#xD;
          -  Analphabetism&#xD;
&#xD;
          -  Unability of German language use&#xD;
&#xD;
          -  Anacusis or Hypoacusis with hearing aid device, Amaurosis&#xD;
&#xD;
          -  Allergies to any ingredient of the electrode fixing material&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  The informed consent of the patient or the subject's legally acceptable representative&#xD;
             can´t be obtained in time&#xD;
&#xD;
          -  Patient has a power of attorney or patient's provision, where he/she refuses&#xD;
             participation in any clinical trial&#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>Claudia Spies, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>October 16, 2015</last_update_submitted>
  <last_update_submitted_qc>October 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Univ.-Prof. Dr. Claudia Spies</investigator_title>
  </responsible_party>
  <keyword>delirium, light, ICU, sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</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/NCT01727375
org study id: PreDeLight-ICU
nct id: NCT01727375
lead sponsor: 
has dmc: No
The purpose of this multicenter randomised controlled trial is to investigate if circadian
      light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces
      prevalence of delirium in mechanically ventilated intensive care unit patients.
Patients, who are randomly assigned to the "Lightening arm" will have the circadian light for
      the whole ICU stay. Light levels at the patients bedside will be measured continuously:
      embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue
      color bands and a white light measurement in lux
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Prevalence of delirium
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
description: Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
measure: Delirium prevalence
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
description: In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)
measure: Severity of delirium
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
description: Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)
measure: Duration of delirium
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Prevalence of subsyndromal delirium (SSD)
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Severity of anxiety
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Cognitive Dysfunction
time frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge
measure: Post-Traumatic Stress Disorder (PTSD)
time frame: 6 and 12 months after hospital discharge
measure: Sleep quality
time frame: In the night, starting 48 hours after ICU admission
measure: ICU length of stay
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Duration of mechanical ventilation
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Hospital length of stay
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks
measure: Level of sedation
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Pain level
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered opioids
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered benzodiazepines
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered sedatives
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered antipsychotics
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Mortality
time frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge
measure: Light levels (lux) Light levels (lux)
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Light frequencies
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Noise levels (decibel)
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
arm group label: Standard light
arm group type: No Intervention
description: In this arm patients receive standard lightening conditions
arm group label: Ciradian light
arm group type: Experimental
description: In this arm patients receive artificial ceiling light (circadian light) at the bedside.
intervention type: Other
intervention name: Circadian light
description: Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require.
Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.
arm group label: Ciradian light
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, MD, Prof.
role: Study Director
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Univ.-Prof. Dr. Claudia Spies
mesh term: Delirium