<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/NCT02977338</url>
  </required_header>
  <id_info>
    <org_study_id>0052-16-HYMC</org_study_id>
    <nct_id>NCT02977338</nct_id>
  </id_info>
  <brief_title>Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment</brief_title>
  <official_title>Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic&#xD;
      upper airway evaluation during artificial sleep before surgical treatment for patients with&#xD;
      obstructed sleep apnea (OSA).&#xD;
&#xD;
      DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider&#xD;
      it a fundamental clinical procedure that is essential before choosing the surgical treatment.&#xD;
      The investigator's results so far suggest that a multilevel collapse is significantly&#xD;
      associated with higher apnea hypopnea index values. The investigators think that the weight&#xD;
      did not play a significant role in RDI reduction. Results till now show that tailored surgery&#xD;
      based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate&#xD;
      based on the investigator's experience The aim of this study is to evaluate surgery results&#xD;
      in patients who underwent DISE prior to their surgery in comparison to their condition prior&#xD;
      to the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic&#xD;
      upper airway evaluation during artificial sleep before surgical treatment for patients with&#xD;
      obstructed sleep apnea (OSA).&#xD;
&#xD;
      Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with&#xD;
      snoring and OSA.&#xD;
&#xD;
      DISE is a safe procedure, easily practicable, valid and reliable. It is considered a&#xD;
      fundamental clinical procedure that is essential before choosing the surgical treatment.&#xD;
      Results so far suggest that a multilevel collapse is significantly associated with higher&#xD;
      apnea hypopnea index values. The investigators think that the weight did not play a&#xD;
      significant role in RDI reduction. Results till now show that tailored surgery based on DISE&#xD;
      may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the&#xD;
      investigator's experience The aim of this tudy is to evaluate surgery results in patients who&#xD;
      underwent DISE prior to their surgery in comparison to their condition prior to the&#xD;
      treatment.&#xD;
&#xD;
      The results of the DISE based treatment will be compared with literature data from patients&#xD;
      who underwent the surgery without DISE.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      A retrospective follow-up study. Patients with snoring and OSA, had sleep study and had DISE&#xD;
      before deciding on the surgical treatment. DISE findings were reported using the NOHL and&#xD;
      VOTE classifications systems; site, degree of airway narrowing and configuration of&#xD;
      obstruction. Patients underwent tailored surgery based on DISE findings included multi-level&#xD;
      surgery; palate, tonsils, base of tongue and epiglottis.&#xD;
&#xD;
      After examining the results of the surgery in the patients, a comparison will be made based&#xD;
      on sleep laboratory parameters (RDI, minimum saturation, degree of sleep apnea, degree of&#xD;
      snoring) with data from the literature for patients who did not undergo DISE. On the whole,&#xD;
      the degree of improvement in the patient's condition will be assessed.&#xD;
&#xD;
      We would like to show preference in surgery outcome in patients who were diagnosed using&#xD;
      DISE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Disturbance Index (RDI)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>minimum saturation</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>degree of sleep apnea</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>degree of snoring</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>OSA</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective review</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with snoring and OSA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-90&#xD;
&#xD;
          -  Female or Male&#xD;
&#xD;
          -  Fully diagnosed patients with OSA (including sleep laboratory) who are candidates for&#xD;
             surgery as a treatment for their condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not candidates for surgery as a treatment for their OSA.&#xD;
&#xD;
          -  Patients with high surgical risk.&#xD;
&#xD;
          -  Patients with hematological and oncological background.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977338
org study id: 0052-16-HYMC
nct id: NCT02977338
lead sponsor: 
has dmc: No
Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic
      upper airway evaluation during artificial sleep before surgical treatment for patients with
      obstructed sleep apnea (OSA).

      DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider
      it a fundamental clinical procedure that is essential before choosing the surgical treatment.
      The investigator's results so far suggest that a multilevel collapse is significantly
      associated with higher apnea hypopnea index values. The investigators think that the weight
      did not play a significant role in RDI reduction. Results till now show that tailored surgery
      based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate
      based on the investigator's experience The aim of this study is to evaluate surgery results
      in patients who underwent DISE prior to their surgery in comparison to their condition prior
      to the treatment.
Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic
      upper airway evaluation during artificial sleep before surgical treatment for patients with
      obstructed sleep apnea (OSA).

      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. It is considered a
      fundamental clinical procedure that is essential before choosing the surgical treatment.
      Results so far suggest that a multilevel collapse is significantly associated with higher
      apnea hypopnea index values. The investigators think that the weight did not play a
      significant role in RDI reduction. Results till now show that tailored surgery based on DISE
      may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the
      investigator's experience The aim of this tudy is to evaluate surgery results in patients who
      underwent DISE prior to their surgery in comparison to their condition prior to the
      treatment.

      The results of the DISE based treatment will be compared with literature data from patients
      who underwent the surgery without DISE.

      Method:

      A retrospective follow-up study. Patients with snoring and OSA, had sleep study and had DISE
      before deciding on the surgical treatment. DISE findings were reported using the NOHL and
      VOTE classifications systems; site, degree of airway narrowing and configuration of
      obstruction. Patients underwent tailored surgery based on DISE findings included multi-level
      surgery; palate, tonsils, base of tongue and epiglottis.

      After examining the results of the surgery in the patients, a comparison will be made based
      on sleep laboratory parameters (RDI, minimum saturation, degree of sleep apnea, degree of
      snoring) with data from the literature for patients who did not undergo DISE. On the whole,
      the degree of improvement in the patient's condition will be assessed.

      We would like to show preference in surgery outcome in patients who were diagnosed using
      DISE.
observational model: Cohort
time perspective: Retrospective
measure: Respiratory Disturbance Index (RDI)
time frame: 12 months
measure: minimum saturation
time frame: 12 month
measure: degree of sleep apnea
time frame: 12 month
measure: degree of snoring
time frame: 12 month
intervention type: Other
intervention name: Retrospective review
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided