<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/NCT03776084</url>
  </required_header>
  <id_info>
    <org_study_id>2018569</org_study_id>
    <nct_id>NCT03776084</nct_id>
  </id_info>
  <brief_title>Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome</brief_title>
  <acronym>CPAPSH</acronym>
  <official_title>Evaluation of Compliance With CPAP Therapy in Patients Diagnosed With Obstructive Sleep Apnea Syndrome at the Hospital de Sabadell</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</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 aim of the study is to know the adherence to treatment and compliance of patients&#xD;
      diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de&#xD;
      Sabadell.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigatror's objective will be to know the adherence to treatment and compliance of&#xD;
      patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de&#xD;
      Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients&#xD;
      who continue using CPAP one year after initiation of treatment) and objective compliance with&#xD;
      treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405&#xD;
      patients was recruited, recruited consecutively at a rate of 33 patients per month among&#xD;
      those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a&#xD;
      possible abandonment rate of 5%. For the statistical analysis of the data related to&#xD;
      compliance with the therapy and compliance with the follow-up process, descriptive analysis&#xD;
      of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical&#xD;
      analysis of the factors influencing compliance: multivariate logistic regression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Adherence rate to CPAP treatment</measure>
    <time_frame>1 year after starting treatment</time_frame>
    <description>% of patients who still use CPAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of patients with compliance with the treatment</measure>
    <time_frame>1 year after starting treatment</time_frame>
    <description>% of patients use CPAP ≥4h / night</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">405</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>Patients SAHS with CPAP</arm_group_label>
    <description>Continuous Positive Airway Pressure treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Positive Airway Pressure</intervention_name>
    <description>CPAP indication</description>
    <arm_group_label>Patients SAHS with CPAP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with OSAS and who underwent treatment with Continuous Positive Airway&#xD;
        Pressure at the Hospital de Sabadell.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS&#xD;
             (clinical picture and AHI&gt; 10).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a psychiatric illness or dementia.&#xD;
&#xD;
          -  Communication problems or inability to read and speak Spanish.&#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>Montserrat Montaña, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporacion Parc Tauli</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Montserrat Montaña, PhD</last_name>
    <phone>+34692617376</phone>
    <email>mmontana@tauli.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria José Masdeu, MD</last_name>
    <phone>+34937231010</phone>
    <phone_ext>21191</phone_ext>
    <email>mjmasdeu@tauli.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CorporacionPT</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Montserrat Montaña, PhD</last_name>
      <phone>+34692617376</phone>
      <email>mmontana@tauli.cat</email>
    </contact>
    <contact_backup>
      <last_name>Maria José Masdeu, MD</last_name>
      <phone>+34937231010</phone>
      <phone_ext>21191</phone_ext>
      <email>mjmasdeu@tauli.cat</email>
    </contact_backup>
    <investigator>
      <last_name>Montserrat Montaña, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Montserrat Montaña</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Research</investigator_title>
  </responsible_party>
  <keyword>treatment adherence and compliance</keyword>
  <keyword>attitudes</keyword>
  <keyword>Continuous Positive Airway Pressure</keyword>
  <keyword>cross-cultural validation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT03776084
org study id: 2018569
nct id: NCT03776084
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to know the adherence to treatment and compliance of patients
      diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de
      Sabadell.
The investigatror's objective will be to know the adherence to treatment and compliance of
      patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de
      Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients
      who continue using CPAP one year after initiation of treatment) and objective compliance with
      treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405
      patients was recruited, recruited consecutively at a rate of 33 patients per month among
      those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a
      possible abandonment rate of 5%. For the statistical analysis of the data related to
      compliance with the therapy and compliance with the follow-up process, descriptive analysis
      of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical
      analysis of the factors influencing compliance: multivariate logistic regression.
observational model: Cohort
time perspective: Prospective
measure: Adherence rate to CPAP treatment
time frame: 1 year after starting treatment
description: % of patients who still use CPAP
measure: Ratio of patients with compliance with the treatment
time frame: 1 year after starting treatment
description: % of patients use CPAP ≥4h / night
arm group label: Patients SAHS with CPAP
description: Continuous Positive Airway Pressure treatment
intervention type: Device
intervention name: Continuous Positive Airway Pressure
description: CPAP indication
arm group label: Patients SAHS with CPAP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Montserrat Montaña, PHD
role: Principal Investigator
affiliation: Corporacion Parc Tauli
last name: Montserrat Montaña, PhD
phone: +34692617376
email: mmontana@tauli.cat
last name: Maria José Masdeu, MD
phone: +34937231010
phone ext: 21191
email: mjmasdeu@tauli.cat
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Montserrat Montaña
investigator title: Principal Investigator, Clinical Research
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive