<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/NCT01661699</url>
  </required_header>
  <id_info>
    <org_study_id>2011-416</org_study_id>
    <nct_id>NCT01661699</nct_id>
  </id_info>
  <brief_title>Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance</brief_title>
  <official_title>Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to check blood and urine levels to further define markers/tests&#xD;
      in the blood and urine that would be useful in following patients with obstructive sleep&#xD;
      apnea and then to see if by wearing CPAP every night, these markers can be reduced. This&#xD;
      research is being done because currently there are no effective blood or urine markers to&#xD;
      determine how well CPAP is working.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to further define biomarkers that would be useful in following&#xD;
      patients with obstructive sleep apnea and examining their response to compliance to therapy&#xD;
      with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to&#xD;
      CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and&#xD;
      has been show to reduce blood pressure and decrease oxidative stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determining biomarkers for polysomnography characteristics before and after CPAP treatment</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective of this pilot study will determine the biomarkers for polysomnography characteristics with CPAP treatment from baseline to 6 months in patients with obstructive sleep apnea. The results will guide biomarker selection for full scale studies.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>Sleep apnea</arm_group_label>
    <description>Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Those over 18 years suspected of having sleep apnea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and Women over 18 years suspected of having sleep apnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those under 18 years or not suspected of having sleep apnea&#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>Cristina Reichner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Christina Reichner, M.D.</investigator_full_name>
    <investigator_title>M.D., Associate Professor Medicine</investigator_title>
  </responsible_party>
  <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>
  </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/NCT01661699
org study id: 2011-416
nct id: NCT01661699
lead sponsor: 
has dmc: No
The purpose of this study is to check blood and urine levels to further define markers/tests
      in the blood and urine that would be useful in following patients with obstructive sleep
      apnea and then to see if by wearing CPAP every night, these markers can be reduced. This
      research is being done because currently there are no effective blood or urine markers to
      determine how well CPAP is working.
The goal of this study is to further define biomarkers that would be useful in following
      patients with obstructive sleep apnea and examining their response to compliance to therapy
      with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to
      CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and
      has been show to reduce blood pressure and decrease oxidative stress.
observational model: Case-Only
time perspective: Prospective
measure: Determining biomarkers for polysomnography characteristics before and after CPAP treatment
time frame: 6 months
description: The primary objective of this pilot study will determine the biomarkers for polysomnography characteristics with CPAP treatment from baseline to 6 months in patients with obstructive sleep apnea. The results will guide biomarker selection for full scale studies.
arm group label: Sleep apnea
description: Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristina Reichner, MD
role: Principal Investigator
affiliation: Georgetown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Christina Reichner, M.D.
investigator title: M.D., Associate Professor Medicine
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive