<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/NCT03834792</url>
  </required_header>
  <id_info>
    <org_study_id>20170591-01H</org_study_id>
    <nct_id>NCT03834792</nct_id>
  </id_info>
  <brief_title>Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database</brief_title>
  <official_title>Adverse Long-term Consequences of Sleep Disordered Breathing: Using the Ottawa Hospital Sleep Database in Predictive Model Development and Validation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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 primary purpose of the proposed study is to validate our previously developed predictive&#xD;
      model for adults with obstructive sleep apnea using (i) clinical data from multiple large&#xD;
      academic centers, (ii) a longer follow-up period, and (iii) an extended definition of&#xD;
      outcomes of interest.&#xD;
&#xD;
      The TOH sleep database was created as a part of the project: &quot;Validation of provincial health&#xD;
      administrative data algorithms to identify patients with obstructive sleep apnea (OSA):&#xD;
      Feasibility project&quot;. Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to&#xD;
      be used for future clinical, research, educational and quality improvement purposes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of the proposed study is to validate the previously developed predictive&#xD;
      model by the investigators for adults with obstructive sleep apnea using (i) clinical data&#xD;
      from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended&#xD;
      definition of outcomes of interest.&#xD;
&#xD;
      From clinical and quality improvement perspective the TOH database will be used for&#xD;
      description, evaluation, monitoring and/or educational purposes. For example, using this&#xD;
      database the investigators will be able (i) to describe characteristics of individuals who&#xD;
      underwent a diagnostic sleep study at the TOH between 2015 and 2017 to understand better&#xD;
      clinical and health care utilization needs as well as to educate sleep fellows and&#xD;
      technologists; and (ii) to evaluate the quality of the triaging process in the sleep clinic.&#xD;
      This database will be used to: (i) examine risk factors for long-term adverse health&#xD;
      consequences (e.g. cardio-vascular diseases, diabetes, depression, dementia, depression and&#xD;
      cancer) among individuals referred for diagnostic sleep testing in order to identify high&#xD;
      risk groups that are potential targets for education and treatment, (ii) develop health&#xD;
      interventions in order to improve the quality of care and management strategies available for&#xD;
      adults with chronic diseases that are comorbid with obstructive airway diseases and&#xD;
      sleep-related disorders, (iii) evaluate the cost-effectiveness of the developed health&#xD;
      interventions, e.g. screening for obstructive sleep apnea (OSA), evaluation of home versus&#xD;
      laboratory-based diagnosis of OSA, and education strategies, (iv) develop key messages for&#xD;
      different stakeholder groups (health care providers, patients and their relatives, provincial&#xD;
      sleep and lung associations, public health managers, the respiratory vendor among others)&#xD;
      related to diagnosis, education and treatment of patients with respiratory and sleep-related&#xD;
      problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 30, 2018</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Long-term adverse health consequences</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>The primary outcome will be time from the index date (diagnostic sleep study) to the composite outcome of interest which include: cardio-vascular diseases, diabetes, depression, dementia, and cancer as well as chronic lung diseases and all-cause mortality. Conditions of interested will be defined from provincial health administrative data using validated algorithms that have utilized ICD-9 and ICD-10 codes as well as billing codes for outpatients visits, and procedural codes. Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>All-cause mortality, all-cause hospitalizations, emergency department visits and associated costs will be defined from provincial health administrative data. Registered Persons Database will be used to define mortality. Hospitalizations and emergency department visits will be defined using: Discharge Abstract Database (all hospital admission and discharge data), National Ambulatory Care Reporting System (emergency department visits). Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary. Total healthcare expenditures will be calculated using the ICES person-level health utilization costing algorithms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor vehicle crashes</measure>
    <time_frame>Through study completion, up to 10 years</time_frame>
    <description>Different definitions of motor vehicle crashes will be considered. Motor vehicle crashes requiring hospital or emergency department visit: the investigators will identify traffic emergencies characterized as a crash using the International Classification of Diseases codes 10th Revision (V20-V69). The investigators will include emergency department visits involving crashes in which the patient was the driver of the motor vehicle and exclude emergency department visits involving crashes in which the patient was a passenger or pedestrian.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5155</enrollment>
  <condition>Polysomnography</condition>
  <condition>Sleep Apnea Syndromes</condition>
  <condition>Risk Factors</condition>
  <condition>Prognosis</condition>
  <condition>Restless Legs Syndrome</condition>
  <condition>Periodic Limb Movement Sleep Disorder</condition>
  <condition>Sleep Arousal Disorders</condition>
  <condition>Opioid Use</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention but exposure</intervention_name>
    <description>Different sleep disorders will be considered as an exposure. The data elements included in the database: demographics, date of the sleep study, study type, all available polysomnography indices, symptoms, sleep schedule, comorbidities, medications, social history, electrocardiography, positive airway pressure treatment related variables.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Please see above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        • All adults who underwent a diagnostic sleep study in the TOH Sleep Center from Apr 2015&#xD;
        to April 2017&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Uninsured individuals&#xD;
&#xD;
          -  Individuals who did not agree for their data to be linked to the ICES&#xD;
&#xD;
          -  Individuals who underwent split-night sleep studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tetyana Kendzerska, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep disorders</keyword>
  <keyword>Health outcomes</keyword>
  <keyword>Predictive model</keyword>
  <keyword>Health care utilization</keyword>
  <keyword>Validation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Sleep Arousal Disorders</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We have not decided yet if IPD will be available to other researchers.</ipd_description>
  </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/NCT03834792
org study id: 20170591-01H
nct id: NCT03834792
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of the proposed study is to validate our previously developed predictive
      model for adults with obstructive sleep apnea using (i) clinical data from multiple large
      academic centers, (ii) a longer follow-up period, and (iii) an extended definition of
      outcomes of interest.

      The TOH sleep database was created as a part of the project: "Validation of provincial health
      administrative data algorithms to identify patients with obstructive sleep apnea (OSA):
      Feasibility project". Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to
      be used for future clinical, research, educational and quality improvement purposes.
The primary purpose of the proposed study is to validate the previously developed predictive
      model by the investigators for adults with obstructive sleep apnea using (i) clinical data
      from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended
      definition of outcomes of interest.

      From clinical and quality improvement perspective the TOH database will be used for
      description, evaluation, monitoring and/or educational purposes. For example, using this
      database the investigators will be able (i) to describe characteristics of individuals who
      underwent a diagnostic sleep study at the TOH between 2015 and 2017 to understand better
      clinical and health care utilization needs as well as to educate sleep fellows and
      technologists; and (ii) to evaluate the quality of the triaging process in the sleep clinic.
      This database will be used to: (i) examine risk factors for long-term adverse health
      consequences (e.g. cardio-vascular diseases, diabetes, depression, dementia, depression and
      cancer) among individuals referred for diagnostic sleep testing in order to identify high
      risk groups that are potential targets for education and treatment, (ii) develop health
      interventions in order to improve the quality of care and management strategies available for
      adults with chronic diseases that are comorbid with obstructive airway diseases and
      sleep-related disorders, (iii) evaluate the cost-effectiveness of the developed health
      interventions, e.g. screening for obstructive sleep apnea (OSA), evaluation of home versus
      laboratory-based diagnosis of OSA, and education strategies, (iv) develop key messages for
      different stakeholder groups (health care providers, patients and their relatives, provincial
      sleep and lung associations, public health managers, the respiratory vendor among others)
      related to diagnosis, education and treatment of patients with respiratory and sleep-related
      problems.
observational model: Cohort
time perspective: Retrospective
measure: Long-term adverse health consequences
time frame: Through study completion, up to 10 years
description: The primary outcome will be time from the index date (diagnostic sleep study) to the composite outcome of interest which include: cardio-vascular diseases, diabetes, depression, dementia, and cancer as well as chronic lung diseases and all-cause mortality. Conditions of interested will be defined from provincial health administrative data using validated algorithms that have utilized ICD-9 and ICD-10 codes as well as billing codes for outpatients visits, and procedural codes. Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary.
measure: Health care utilization
time frame: Through study completion, up to 10 years
description: All-cause mortality, all-cause hospitalizations, emergency department visits and associated costs will be defined from provincial health administrative data. Registered Persons Database will be used to define mortality. Hospitalizations and emergency department visits will be defined using: Discharge Abstract Database (all hospital admission and discharge data), National Ambulatory Care Reporting System (emergency department visits). Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary. Total healthcare expenditures will be calculated using the ICES person-level health utilization costing algorithms.
measure: Motor vehicle crashes
time frame: Through study completion, up to 10 years
description: Different definitions of motor vehicle crashes will be considered. Motor vehicle crashes requiring hospital or emergency department visit: the investigators will identify traffic emergencies characterized as a crash using the International Classification of Diseases codes 10th Revision (V20-V69). The investigators will include emergency department visits involving crashes in which the patient was the driver of the motor vehicle and exclude emergency department visits involving crashes in which the patient was a passenger or pedestrian.
intervention type: Other
intervention name: No intervention but exposure
description: Different sleep disorders will be considered as an exposure. The data elements included in the database: demographics, date of the sleep study, study type, all available polysomnography indices, symptoms, sleep schedule, comorbidities, medications, social history, electrocardiography, positive airway pressure treatment related variables.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Tetyana Kendzerska, MD, PhD
role: Principal Investigator
affiliation: The Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Restless Legs Syndrome
mesh term: Sleep Arousal Disorders
mesh term: Syndrome
sharing ipd: Undecided
ipd description: We have not decided yet if IPD will be available to other researchers.