<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/NCT03796338</url>
  </required_header>
  <id_info>
    <org_study_id>CEAVC, 8611/2018; 11535/OSS</org_study_id>
    <nct_id>NCT03796338</nct_id>
  </id_info>
  <brief_title>Sleep Quantity and Quality in the ICU: a Prospective Observational Stud</brief_title>
  <official_title>Sleep Quantity and Quality in the ICU: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Careggi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Careggi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several evidences in the literature suggest sleep interruption in critical care patients.&#xD;
      Nowadays, the amount and the quality of sleep phases during the length of stay in the&#xD;
      intensive care unit are largely unknown.&#xD;
&#xD;
      In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during&#xD;
      sleep is quantified.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Sleep N2 phase</measure>
    <time_frame>The sleep architecture will be observed during the first night spent in the ICU</time_frame>
    <description>describe the percentage of the total sleep time spent by the patient in N2 stage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep N1 phase</measure>
    <time_frame>The sleep architecture will be observed during the first night spent in the ICU</time_frame>
    <description>describe the percentage of the total sleep time spent by the patient in N1 stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep N3 phase</measure>
    <time_frame>The sleep architecture will be observed during the first night spent in the ICU</time_frame>
    <description>describe the percentage of the total sleep time spent by the patient in N3 stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep REM phase</measure>
    <time_frame>The sleep architecture will be observed during the first night spent in the ICU</time_frame>
    <description>describe the percentage of the total sleep time spent by the patient in REM stage</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>age &gt; 18 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sleep Profiler</intervention_name>
    <description>Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous enrollment in the same study (sleep recording during previous night)&#xD;
&#xD;
          -  Previous use of hypnotic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianluca Villa, MD</last_name>
    <role>Study Director</role>
    <affiliation>Azienda Careggi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Careggi Hospital</investigator_affiliation>
    <investigator_full_name>Gianluca Villa</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>intensive care unit</keyword>
  <keyword>Sleep interruption</keyword>
  <keyword>Sleep phases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Critical Illness</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/NCT03796338
org study id: CEAVC, 8611/2018; 11535/OSS
nct id: NCT03796338
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Several evidences in the literature suggest sleep interruption in critical care patients.
      Nowadays, the amount and the quality of sleep phases during the length of stay in the
      intensive care unit are largely unknown.

      In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during
      sleep is quantified.
observational model: Cohort
time perspective: Prospective
measure: Sleep N2 phase
time frame: The sleep architecture will be observed during the first night spent in the ICU
description: describe the percentage of the total sleep time spent by the patient in N2 stage
measure: Sleep N1 phase
time frame: The sleep architecture will be observed during the first night spent in the ICU
description: describe the percentage of the total sleep time spent by the patient in N1 stage
measure: Sleep N3 phase
time frame: The sleep architecture will be observed during the first night spent in the ICU
description: describe the percentage of the total sleep time spent by the patient in N3 stage
measure: Sleep REM phase
time frame: The sleep architecture will be observed during the first night spent in the ICU
description: describe the percentage of the total sleep time spent by the patient in REM stage
arm group label: Critically ill patients
description: age > 18 years
intervention type: Device
intervention name: Sleep Profiler
description: Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals.
arm group label: Critically ill patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Gianluca Villa, MD
role: Study Director
affiliation: Azienda Careggi
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Careggi Hospital
investigator full name: Gianluca Villa
investigator title: M.D.
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Critical Illness
sharing ipd: No