<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/NCT02234765</url>
  </required_header>
  <id_info>
    <org_study_id>PI13/02004</org_study_id>
    <nct_id>NCT02234765</nct_id>
  </id_info>
  <brief_title>Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care</brief_title>
  <acronym>GESAP</acronym>
  <official_title>Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sociedad Española de Neumología y Cirugía Torácica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sociedad Española de Neumología y Cirugía Torácica</source>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive&#xD;
      sleepiness secondary to repeated obstruction of the upper airway during sleep and&#xD;
      cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders.&#xD;
      Epidemiological studies in our country have shown that OSA is a highly prevalent disease in&#xD;
      the general population, affecting 2-4% of the adult population. The most important clinical&#xD;
      manifestations of OSAS is a deterioration in the quality of life and an increase in&#xD;
      cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and&#xD;
      considering the medical complications of OSA, as well as the sociolaboral impact and its&#xD;
      negative impact on quality of life and survival; is stated that this disease is a public&#xD;
      health problem that requires the physician to identify patients eligible to treatment.&#xD;
      Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health&#xD;
      resources, comparing when the diagnosis and treatment has been established. Finally, we have&#xD;
      a highly effective treatment using positive pressure in the upper airway (CPAP) that has been&#xD;
      shown to be effective and cost-effective. The current situation in which all patients&#xD;
      diagnosed with OSA and receiving different treatments are monitored and controlled by the&#xD;
      Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our&#xD;
      working hypothesis is: &quot;By the coordination of actions at various levels including&#xD;
      interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records&#xD;
      and the use of new technologies can be achieved in AP satisfactory management of the&#xD;
      diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both&#xD;
      areas have a level of clinical response, satisfaction, compliance and avoidance of&#xD;
      complications, similar to that obtained with monitoring by SU. In addition, management by AP&#xD;
      will be more cost-effective than in the SU.&quot;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in daytime sleepiness (ESS score) at 6 months</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Epworth Sleepiness Scale (ESS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost-effectiveness at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>QUALYS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of life</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>EuroQol (EQ5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPAP compliance at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Objective data to be downloaded from the CPAP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse events / secondary effects related to CPAP compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood pressure</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Office blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in body mass index</measure>
    <time_frame>Baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lost of follow up / Abandons at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Sleep Unit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients diagnosed and followed up in the Sleep Unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed and followed up in the Primary Care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Primary Care-based management</intervention_name>
    <description>Patients will be diagnosed and follow-up in Primary Care.</description>
    <arm_group_label>Primary Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard management</intervention_name>
    <description>Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.</description>
    <arm_group_label>Sleep Unit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women over 18 years old&#xD;
&#xD;
          -  Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or&#xD;
             resistant hypertension&#xD;
&#xD;
          -  Written informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with impaired lung function (sd. overlap, obesity hypoventilation, and&#xD;
             restrictive disorders)&#xD;
&#xD;
          -  Severe heart failure&#xD;
&#xD;
          -  Severe chronic pathology associated&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Periodic leg movements&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Other dyssomnias or parasomnias&#xD;
&#xD;
          -  Patients already treated with CPAP&#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>Ferran Barbe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Arnau de Vilanova. IRB Lleida. CIBERes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova-Santa María</name>
      <address>
        <city>Lleida</city>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sociedad Española de Neumología y Cirugía Torácica</investigator_affiliation>
    <investigator_full_name>Ferran Barbe</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>OSA</keyword>
  <keyword>OSAS</keyword>
  <keyword>Sleep apnea</keyword>
  <keyword>Management</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Sleep Unit</keyword>
  <keyword>Cost-Effectiveness</keyword>
  <keyword>ESS</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>Syndrome</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/NCT02234765
org study id: PI13/02004
nct id: NCT02234765
lead sponsor: 
collaborator: 
Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive
      sleepiness secondary to repeated obstruction of the upper airway during sleep and
      cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders.
      Epidemiological studies in our country have shown that OSA is a highly prevalent disease in
      the general population, affecting 2-4% of the adult population. The most important clinical
      manifestations of OSAS is a deterioration in the quality of life and an increase in
      cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and
      considering the medical complications of OSA, as well as the sociolaboral impact and its
      negative impact on quality of life and survival; is stated that this disease is a public
      health problem that requires the physician to identify patients eligible to treatment.
      Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health
      resources, comparing when the diagnosis and treatment has been established. Finally, we have
      a highly effective treatment using positive pressure in the upper airway (CPAP) that has been
      shown to be effective and cost-effective. The current situation in which all patients
      diagnosed with OSA and receiving different treatments are monitored and controlled by the
      Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our
      working hypothesis is: "By the coordination of actions at various levels including
      interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records
      and the use of new technologies can be achieved in AP satisfactory management of the
      diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both
      areas have a level of clinical response, satisfaction, compliance and avoidance of
      complications, similar to that obtained with monitoring by SU. In addition, management by AP
      will be more cost-effective than in the SU."
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change from baseline in daytime sleepiness (ESS score) at 6 months
time frame: baseline and 6 months
description: Epworth Sleepiness Scale (ESS)
measure: Cost-effectiveness at 6 months
time frame: 6 months
description: QUALYS
measure: Change from baseline in quality of life
time frame: baseline and 6 months
description: EuroQol (EQ5D)
measure: Satisfaction at 6 months
time frame: 6 months
description: Visual analog scale
measure: CPAP compliance at 6 months
time frame: 6 months
description: Objective data to be downloaded from the CPAP device
measure: Adverse events at 6 months
time frame: 6 months
description: Adverse events / secondary effects related to CPAP compliance.
measure: Change from baseline in blood pressure
time frame: Baseline and 6 months
description: Office blood pressure
measure: Change from baseline in body mass index
time frame: Baseline and 6 months
measure: Lost of follow up / Abandons at 6 months
time frame: 6 months
arm group label: Sleep Unit
arm group type: Active Comparator
description: Patients diagnosed and followed up in the Sleep Unit.
arm group label: Primary Care
arm group type: Experimental
description: Patients diagnosed and followed up in the Primary Care.
intervention type: Other
intervention name: Primary Care-based management
description: Patients will be diagnosed and follow-up in Primary Care.
arm group label: Primary Care
intervention type: Other
intervention name: Standard management
description: Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
arm group label: Sleep Unit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ferran Barbe, MD
role: Principal Investigator
affiliation: Hospital Arnau de Vilanova. IRB Lleida. CIBERes
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Sociedad Española de Neumología y Cirugía Torácica
investigator full name: Ferran Barbe
investigator title: MD
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Syndrome