<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/NCT02976207</url>
  </required_header>
  <id_info>
    <org_study_id>55-2015</org_study_id>
    <nct_id>NCT02976207</nct_id>
  </id_info>
  <brief_title>Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment</brief_title>
  <acronym>OSA</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <brief_summary>
    <textblock>
      Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical&#xD;
      treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic&#xD;
      upper airway evaluation during artificial sleep before surgical treatment for patients with&#xD;
      obstructed&#xD;
&#xD;
      .)OSA(sleep apnea&#xD;
&#xD;
        -  Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with&#xD;
           snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We&#xD;
           consider it a fundamental clinical procedure that is essential before choosing the&#xD;
           surgical treatment. Our results so far suggest that a multilevel collapse is&#xD;
           significantly associated with higher apnea hypopnea index values. We think that the&#xD;
           weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction.&#xD;
           Our results till now show tailored surgery based on DISE may leverage sleep surgeries&#xD;
           outcome significantly presenting 70% success rate based&#xD;
&#xD;
        -  on our experience We therefore want to evaluate the patients in a long follow up period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire</measure>
    <time_frame>up to 3 years after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality assessment questionnaire</measure>
    <time_frame>up to 3 years after surgery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>OSA</condition>
  <arm_group>
    <arm_group_label>OSA diagnosed patients</arm_group_label>
    <description>patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA&#xD;
        and are surgery candidates for their condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fully diagnosed patients with OSA.&#xD;
&#xD;
          -  Patients who are candidates for a surgery as a treatment to their condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who are not OSA surgery candidates.&#xD;
&#xD;
          -  Patients with high surgical risk.&#xD;
&#xD;
          -  Patients with hematological or oncological background.&#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>Hillel Yafe medical center</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Itzhak Braverman, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02976207
org study id: 55-2015
nct id: NCT02976207
lead sponsor: 
Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical
      treatment
Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic
      upper airway evaluation during artificial sleep before surgical treatment for patients with
      obstructed

      .)OSA(sleep apnea

        -  Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with
           snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We
           consider it a fundamental clinical procedure that is essential before choosing the
           surgical treatment. Our results so far suggest that a multilevel collapse is
           significantly associated with higher apnea hypopnea index values. We think that the
           weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction.
           Our results till now show tailored surgery based on DISE may leverage sleep surgeries
           outcome significantly presenting 70% success rate based

        -  on our experience We therefore want to evaluate the patients in a long follow up period
observational model: Cohort
time perspective: Prospective
measure: Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire
time frame: up to 3 years after surgery
measure: Sleep quality assessment questionnaire
time frame: up to 3 years after surgery
arm group label: OSA diagnosed patients
description: patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
contact: 
country: Israel
responsible party type: Sponsor