xml: <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/NCT06017921</url>
    </required_header>
    <id_info>
      <org_study_id>ComisaEszopiclone</org_study_id>
      <nct_id>NCT06017921</nct_id>
    </id_info>
    <brief_title>Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA</brief_title>
    <official_title>Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sao Paulo General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and&#xD;
        associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than&#xD;
        among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or&#xD;
        placebo for 14 days on adherence to CPAP after 30 days and after 6 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive&#xD;
        impairment of quality of sleep and quality of life compared to patients with insomnia or OSA&#xD;
        alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with&#xD;
        isolated OSA. The best therapeutic approach for patients with COMISA is still unclear.&#xD;
        Hypnotics have not been tested among patients with COMISA and indication for CPAP.&#xD;
  &#xD;
        The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on&#xD;
        adherence to CPAP after 30 days and after 6 months. In addition, the investigators will&#xD;
        assess the effect eszopiclone on insomnia severity, quality of life, anxiety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">May 11, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <phase>Phase 4</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>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Short-term CPAP adherence (use &gt; 4 hours per night through Resmed program)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Compare the effect of Eszopiclone 3mg or placebo for 14 days on one-month CPAP adherence (use &gt; 4 hours per night through Resmed program) after 4 weeks days.&#xD;
  Adherence to CPAP will be assess by the average number of hours of use (&gt;=4h). The investigators will use Resmed's program for this analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Long-term CPAP adherence (use &gt; 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety</measure>
      <time_frame>6 months</time_frame>
      <description>Compare the effect of Eszopiclone 3mg or placebo for 14 days on 6 months CPAP adherence (use &gt; 4 hours per night through Resmed program), sleep quality, insomnia and anxiety through questionnaries.&#xD;
  Adherence to CPAP will be assess by the average number of hours of use (&gt;=4h). The investigators will use Resmed's program for this analysis.&#xD;
  The sleep quality, insomnia and anxiety will be assess through questionnaires.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>Eszopiclone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Eszopiclone 3mg at bed time for 14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo at bed time for 14 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Eszopiclone 3 mg</intervention_name>
      <description>Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm</description>
      <arm_group_label>Eszopiclone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of Insomnia;&#xD;
  &#xD;
            -  Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that&#xD;
               potentially impair CPAP use;&#xD;
  &#xD;
            -  Use of hypnotics for more than 7 days in the last 2 months;&#xD;
  &#xD;
            -  Renal dysfunction (serum creatinine &gt;2mg/dL);&#xD;
  &#xD;
            -  Severe liver or cardiac dysfunction;&#xD;
  &#xD;
            -  Alcoholism;&#xD;
  &#xD;
            -  Previous CPAP or mandibular advancement device for OSA treatment in the last 12&#xD;
               months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pedro R Genta, MD.</last_name>
      <phone>551126615486</phone>
      <email>prgenta@usp.br</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo</name>
        <address>
          <city>Sao Paulo</city>
          <zip>55</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pedro R Genta, MD</last_name>
        <phone>551126625486</phone>
        <email>prgenta@usp.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
      <investigator_full_name>Pedro Rodrigues Genta</investigator_full_name>
      <investigator_title>Principal Investigador</investigator_title>
    </responsible_party>
    <keyword>COMISA</keyword>
    <keyword>Obstructive Sleep Apnea</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>
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eszopiclone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017921
  org study id: ComisaEszopiclone
  nct id: NCT06017921
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and
        associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than
        among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or
        placebo for 14 days on adherence to CPAP after 30 days and after 6 months.
  The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive
        impairment of quality of sleep and quality of life compared to patients with insomnia or OSA
        alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with
        isolated OSA. The best therapeutic approach for patients with COMISA is still unclear.
        Hypnotics have not been tested among patients with COMISA and indication for CPAP.
  
        The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on
        adherence to CPAP after 30 days and after 6 months. In addition, the investigators will
        assess the effect eszopiclone on insomnia severity, quality of life, anxiety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  masking description: double-blind
  measure: Short-term CPAP adherence (use > 4 hours per night through Resmed program)
  time frame: 4 weeks
  description: Compare the effect of Eszopiclone 3mg or placebo for 14 days on one-month CPAP adherence (use > 4 hours per night through Resmed program) after 4 weeks days.
  Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis.
  measure: Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety
  time frame: 6 months
  description: Compare the effect of Eszopiclone 3mg or placebo for 14 days on 6 months CPAP adherence (use > 4 hours per night through Resmed program), sleep quality, insomnia and anxiety through questionnaries.
  Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis.
  The sleep quality, insomnia and anxiety will be assess through questionnaires.
  arm group label: Eszopiclone
  arm group type: Active Comparator
  description: Eszopiclone 3mg at bed time for 14 days
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo at bed time for 14 days
  intervention type: Drug
  intervention name: Eszopiclone 3 mg
  description: Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
  arm group label: Eszopiclone
  intervention type: Drug
  intervention name: Placebo
  description: Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pedro R Genta, MD.
  phone: 551126615486
  email: prgenta@usp.br
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Sao Paulo General Hospital
  investigator full name: Pedro Rodrigues Genta
  investigator title: Principal Investigador
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Sleep Initiation and Maintenance Disorders
  mesh term: Eszopiclone