<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/NCT03819361</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02305</org_study_id>
    <nct_id>NCT03819361</nct_id>
  </id_info>
  <brief_title>Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea</brief_title>
  <acronym>ELSA</acronym>
  <official_title>Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malcolm Kohler</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease,&#xD;
      caused by recurrent episodes of partial or complete collapse of the upper airway during&#xD;
      sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure,&#xD;
      and increased sympathetic nervous system activity. A single-night sleep study (i.e.&#xD;
      respiratory polygraphy or polysomnography) is currently considered to be the gold standard&#xD;
      for diagnosing OSA. However, recent studies suggest a significant intra-individual&#xD;
      night-to-night variability of respiratory events, leading to the hypothesis that one&#xD;
      single-night study might not reflect an accurate picture of the disease.&#xD;
&#xD;
      Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the&#xD;
      regular diagnostic procedure recommended by the current guidelines. In addition to the&#xD;
      in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry&#xD;
      at home. By computing and analysing sensitivity and specificity of every additional night,&#xD;
      the investigator will answer the questions how many nights of sleep monitoring by home&#xD;
      oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could&#xD;
      reduce the number of false-negative and false- positive results compared to the in-hospital&#xD;
      single-night study.&#xD;
&#xD;
      Part B: Based on the patients' data of part A, the investigator will develop a questionnaire&#xD;
      and present anonymized cases to experts in the field of sleep medicine. Thereby, the&#xD;
      investigator will evaluate if the additional information of repeated nocturnal&#xD;
      pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of&#xD;
      OSA.&#xD;
&#xD;
      In a second step, the investigator will perform a classical Delphi study with a panel of&#xD;
      experts in sleep medicine to establish consensus on repeated sleep studies and how they&#xD;
      should be used for diagnosis and treatment in patients with suspected OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
    <description>&quot;Sensitivity&quot; and &quot;specificity&quot; for every additional night will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ODI variability measured in 14 consecutive nights of pulse-oximetry</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA</measure>
    <time_frame>14 nights of pulse-oximetry</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Suspected OSA</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pulse-oximetry</intervention_name>
    <description>Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich</description>
    <arm_group_label>Suspected OSA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected obstructive sleep apnea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Suspected obstructive sleep apnea&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or diagnosed sleeping-disordered breathing other than OSA&#xD;
&#xD;
          -  Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV&#xD;
             and heart failure NYHA III-IV&#xD;
&#xD;
          -  Patients receiving oxygen therapy or home ventilation&#xD;
&#xD;
          -  Continuous positive airway pressure treatment for OSA at baseline&#xD;
&#xD;
          -  Physical or intellectual impairment precluding informed consent or protocol adherence&#xD;
&#xD;
          -  Pregnant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malcolm Kohler, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Malcolm Kohler</investigator_full_name>
    <investigator_title>Head of the department of pulmonology</investigator_title>
  </responsible_party>
  <keyword>Night-to-night variability</keyword>
  <keyword>Apnoea-Hypopnoea Index</keyword>
  <keyword>Oxygen Desaturation Index</keyword>
  <keyword>Pulse-oximetry</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/NCT03819361
org study id: 2018-02305
nct id: NCT03819361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease,
      caused by recurrent episodes of partial or complete collapse of the upper airway during
      sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure,
      and increased sympathetic nervous system activity. A single-night sleep study (i.e.
      respiratory polygraphy or polysomnography) is currently considered to be the gold standard
      for diagnosing OSA. However, recent studies suggest a significant intra-individual
      night-to-night variability of respiratory events, leading to the hypothesis that one
      single-night study might not reflect an accurate picture of the disease.

      Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the
      regular diagnostic procedure recommended by the current guidelines. In addition to the
      in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry
      at home. By computing and analysing sensitivity and specificity of every additional night,
      the investigator will answer the questions how many nights of sleep monitoring by home
      oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could
      reduce the number of false-negative and false- positive results compared to the in-hospital
      single-night study.

      Part B: Based on the patients' data of part A, the investigator will develop a questionnaire
      and present anonymized cases to experts in the field of sleep medicine. Thereby, the
      investigator will evaluate if the additional information of repeated nocturnal
      pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of
      OSA.

      In a second step, the investigator will perform a classical Delphi study with a panel of
      experts in sleep medicine to establish consensus on repeated sleep studies and how they
      should be used for diagnosis and treatment in patients with suspected OSA.
observational model: Cohort
time perspective: Prospective
measure: The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights
time frame: 14 nights of pulse-oximetry
description: "Sensitivity" and "specificity" for every additional night will be assessed
measure: Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring
time frame: 14 nights of pulse-oximetry
measure: ODI variability measured in 14 consecutive nights of pulse-oximetry
time frame: 14 nights of pulse-oximetry
measure: Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability
time frame: 14 nights of pulse-oximetry
measure: Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry
time frame: 14 nights of pulse-oximetry
measure: Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring
time frame: 14 nights of pulse-oximetry
measure: Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA
time frame: 14 nights of pulse-oximetry
arm group label: Suspected OSA
intervention type: Diagnostic Test
intervention name: pulse-oximetry
description: Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich
arm group label: Suspected OSA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Malcolm Kohler, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Malcolm Kohler
investigator title: Head of the department of pulmonology
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive