<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/NCT01681043</url>
  </required_header>
  <id_info>
    <org_study_id>S-20120001</org_study_id>
    <nct_id>NCT01681043</nct_id>
  </id_info>
  <brief_title>Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vejle Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep investigation in respirator treated ICU patients: the importance of intensive&#xD;
      environment.&#xD;
&#xD;
      Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and&#xD;
      increased mortality.&#xD;
&#xD;
      The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise,&#xD;
      light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep&#xD;
      quality in respirator treated ICU patients.&#xD;
&#xD;
      Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc.&#xD;
      AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary&#xD;
      circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m.&#xD;
      after randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the number of arousals</measure>
    <time_frame>per hour of sleep</time_frame>
    <description>arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total sleep time</measure>
    <time_frame>24 hours</time_frame>
    <description>total sleep time during 24 hour period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N1 sleep</measure>
    <time_frame>24 hours</time_frame>
    <description>N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N2 sleep</measure>
    <time_frame>24 hours</time_frame>
    <description>N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N3 sleep</measure>
    <time_frame>24 hours</time_frame>
    <description>N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>REM sleep</measure>
    <time_frame>24 hours</time_frame>
    <description>REM sleep will be scored during sleep periods and the percent of REM sleep will be counted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>24 hour PSG under ordinary conditions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>24 hour PSG in 46 patients under ordinary (routine) conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>24 hours PSG under protocol 'Quiet in the room'</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>protocol 'Quiet in the room'</intervention_name>
    <description>Protocol 'Quite in the room' between 10 p.m. and 6 a.m.&#xD;
nurse nearby&#xD;
no visits after 10 p.m.&#xD;
decreased alarm sound in ventilator and monitor&#xD;
decreased light intensity&#xD;
no unnecessary conversations around the patient&#xD;
medication should be limited to max 1-2 times in this time period&#xD;
no unnecessary therapeutic or diagnostic procedures in this time period&#xD;
earplugs and sleep masks</description>
    <arm_group_label>24 hours PSG under protocol 'Quiet in the room'</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  awake and relevant respirator treated patients with expected 2 or more respirator dags&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GCS &lt; 11&#xD;
&#xD;
          -  cerebral hemorrhage or infarction during the current hospitalization&#xD;
&#xD;
          -  delirium&#xD;
&#xD;
          -  inotropes and/or vasopressors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anaesthesia and Intensive Care, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>March 24, 2015</last_update_submitted>
  <last_update_submitted_qc>March 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vejle Hospital</investigator_affiliation>
    <investigator_full_name>Yuliya Boyko</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Sleep</keyword>
  <!-- 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/NCT01681043
org study id: S-20120001
nct id: NCT01681043
lead sponsor: 
has dmc: No
Sleep investigation in respirator treated ICU patients: the importance of intensive
      environment.

      Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and
      increased mortality.

      The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise,
      light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep
      quality in respirator treated ICU patients.

      Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc.
      AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary
      circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m.
      after randomization.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: the number of arousals
time frame: per hour of sleep
description: arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
measure: total sleep time
time frame: 24 hours
description: total sleep time during 24 hour period
measure: N1 sleep
time frame: 24 hours
description: N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
measure: N2 sleep
time frame: 24 hours
description: N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
measure: N3 sleep
time frame: 24 hours
description: N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
measure: REM sleep
time frame: 24 hours
description: REM sleep will be scored during sleep periods and the percent of REM sleep will be counted
arm group label: 24 hour PSG under ordinary conditions
arm group type: No Intervention
description: 24 hour PSG in 46 patients under ordinary (routine) conditions
arm group label: 24 hours PSG under protocol 'Quiet in the room'
arm group type: Active Comparator
description: 24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
intervention type: Behavioral
intervention name: protocol 'Quiet in the room'
description: Protocol 'Quite in the room' between 10 p.m. and 6 a.m.
nurse nearby
no visits after 10 p.m.
decreased alarm sound in ventilator and monitor
decreased light intensity
no unnecessary conversations around the patient
medication should be limited to max 1-2 times in this time period
no unnecessary therapeutic or diagnostic procedures in this time period
earplugs and sleep masks
arm group label: 24 hours PSG under protocol 'Quiet in the room'
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Vejle Hospital
investigator full name: Yuliya Boyko
investigator title: MD