<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/NCT03281525</url>
  </required_header>
  <id_info>
    <org_study_id>SQ_Heart2017</org_study_id>
    <nct_id>NCT03281525</nct_id>
  </id_info>
  <brief_title>Sleep Quality Underwent Heart Transplant, an Observational Study</brief_title>
  <acronym>SQ_Heart</acronym>
  <official_title>Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SQ_Heart has been designed as an observational study that evaluates the difference in&#xD;
      sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98&#xD;
      Cardiotransplant patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Primary objective of the SQ_Heart study is to evaluate the significant difference in&#xD;
      sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant&#xD;
      patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of &gt; 5 for&#xD;
      poor sleepers.&#xD;
&#xD;
      Patients, to be enrolled, must provide:&#xD;
&#xD;
        -  Age ≥ 18 and &lt; 90;&#xD;
&#xD;
        -  Cardiotransplant patients, with VAD or non;&#xD;
&#xD;
        -  patients with VAD.&#xD;
&#xD;
        -  subjects able to sign informed consent.&#xD;
&#xD;
      All the patients will have to complete some questionnaires:&#xD;
&#xD;
        -  questionnaire about the diagnosis of pathology and lifestyle;&#xD;
&#xD;
        -  questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep&#xD;
           Quality (PSQI);&#xD;
&#xD;
        -  questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).&#xD;
&#xD;
      Questionnaires are necessary for the data collection for the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality Index</measure>
    <time_frame>up 30 days</time_frame>
    <description>sleep quality</description>
  </primary_outcome>
  <enrollment type="Actual">176</enrollment>
  <condition>Ventricular Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and &lt; 90;&#xD;
&#xD;
          -  Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;&#xD;
&#xD;
          -  patients with VAD ;&#xD;
&#xD;
          -  subjects able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18;&#xD;
&#xD;
          -  subjects don't sign informed consent;&#xD;
&#xD;
          -  hospitalization for more than 30 days before compilation in intensive care unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiotransplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</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/NCT03281525
org study id: SQ_Heart2017
nct id: NCT03281525
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The SQ_Heart has been designed as an observational study that evaluates the difference in
      sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98
      Cardiotransplant patients.
The Primary objective of the SQ_Heart study is to evaluate the significant difference in
      sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant
      patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of > 5 for
      poor sleepers.

      Patients, to be enrolled, must provide:

        -  Age ≥ 18 and < 90;

        -  Cardiotransplant patients, with VAD or non;

        -  patients with VAD.

        -  subjects able to sign informed consent.

      All the patients will have to complete some questionnaires:

        -  questionnaire about the diagnosis of pathology and lifestyle;

        -  questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep
           Quality (PSQI);

        -  questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).

      Questionnaires are necessary for the data collection for the study.
observational model: Other
time perspective: Other
measure: Sleep Quality Index
time frame: up 30 days
description: sleep quality
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Ventricular Dysfunction