<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/NCT03043716</url>
  </required_header>
  <id_info>
    <org_study_id>TelePAP_Protokoll_V02_17072017</org_study_id>
    <nct_id>NCT03043716</nct_id>
  </id_info>
  <brief_title>Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP</brief_title>
  <acronym>TelePAP</acronym>
  <official_title>Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and&#xD;
      maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy&#xD;
      on long-term outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Airway obstructions, airflow resistance by partial occlusion of the airways or central&#xD;
      sleep-breathing disorders, where the respiratory effort is reduced or stops, cause a&#xD;
      reduction in airflow and lead to arousals from sleep and disturbances in gas exchange during&#xD;
      sleep. The negative consequences manifest in increases of blood pressure, higher workload for&#xD;
      the heart and daytime sleepiness. PAP (positive airway pressure) treats sleep-related&#xD;
      breathing disorders. It applies pressure to nose and mouth to keep the airway from collapsing&#xD;
      and provides pressure support to assist the respiratory muscles. The efficacy of the therapy&#xD;
      is measured with apnoea- and hypopnoea-indices that count the total number of apnoeic events&#xD;
      at night. To ensure an efficacious and efficient therapy, pressures have to be adjusted&#xD;
      correctly and the patient needs to use PAP regularly.&#xD;
&#xD;
      Telemonitoring is information and communication technology to exchange sleep data and to&#xD;
      provide clinical guidance over distances. There is no defined spectrum of technology. It can&#xD;
      comprise phone calls, video support or interaction programs via the internet. Some studies&#xD;
      point to advantages of telemonitoring in keeping compliance upright, increase usage hours and&#xD;
      some also point to economic advantages. However, we do not have conclusive data from large&#xD;
      trials with telemonitoring on the long-term that would show conclusive effects, be it from&#xD;
      the side of a patient or from a cost and labour perspective of providers or the healthcare&#xD;
      sector. Still, there are uncertainties regarding data safety, reimbursement or connectivity&#xD;
      of different systems.&#xD;
&#xD;
      No long-term data of PAP therapy under telemonitoring and its effect on compliance and&#xD;
      therapy outcomes is available by now.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</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>24 Months</target_duration>
  <primary_outcome>
    <measure>Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring</measure>
    <time_frame>24 months</time_frame>
    <description>Usage Patterns are hours/night and nights/month that therapy has been used. Telemonitoring enables the physician to remotely supervise device usage. Usage will be assessed through data recordings of the device: Days of usage &gt;3hours; Days of usage &lt;3 hours; total recorded days; mean daily usage (minutes); total usage hours (h)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>Sleep disorders are snoring, insomnia, hypersomnia, depression, restless legs syndrome as assessed by anamnesis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>Efficacy is measured through changes in Apnea-Hypopnea-Index AHI (numbers of apneas - reduction of airflow by &gt;90% for at least 10 seconds - and hypopneas - reduction of airflow by &gt;30% for at least 10 seconds with a 4% decrease of Oxygen Saturation - divided by hours of sleep), AI - apnea index (apneas per hour), HI hypopnea index (hypopneas per hour).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with the 24 months follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>Possible causes for therapy Termination are assessed: Lost-to-follow-up, no interest in therapy, changed physician, no therapy benefits, Hospital stay, death</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Central Sleep Apnea</condition>
  <condition>Mixed Sleep Apnea</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PAP therapy with telemonitoring</intervention_name>
    <description>Patients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult individuals with an indication for a therapy with positive airway pressure. Sleep&#xD;
        breathing disorders can be obstructive (obstructive sleep apnea, OSA) or central (CSA)&#xD;
        ranging from mild forms (apnoea-hypopnoea-index ˃ 5 and ˂ 15) over moderate (AHI ˃15 and&#xD;
        ˂30) or severe (AHI ˃ 30).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  New indication for a prescription of a Telemonitoring (AirViewTM)-capable ResMed&#xD;
             PAP-device&#xD;
&#xD;
          -  Consent to use the telemonitoring System AirViewTM (ResMed GmbH &amp; Co KG)&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Pregnant and breastfeeding persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hartmut Grüger, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grand Arc Düsseldorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Oliver Munt, Dr</last_name>
    <phone>+49(0)1629056360</phone>
    <email>oliver.munt@resmed.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Schlaf- und Beatmungszentrum Blaubeuren</name>
      <address>
        <city>Blaubeuren</city>
        <state>Baden-Württemberg</state>
        <zip>89143</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holger Wöhrle</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ambulante Schlafmedizin Herold/Kaa</name>
      <address>
        <city>Fürth</city>
        <state>Bavaria</state>
        <zip>90762</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jürgen Herold, Dr</last_name>
      <phone>09171825880</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg-Med Klinik 3</name>
      <address>
        <city>Nürnberg</city>
        <state>Bavaria</state>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dora Trichè, Dr</last_name>
      <phone>09113980</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinik für Schlafmedizin Düsseldorf Grand Arc</name>
      <address>
        <city>Dusseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40235</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hartmut Grüger, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik Essen</name>
      <address>
        <city>Essen</city>
        <state>Northrhine-Westphalia</state>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Schöbel, Prof</last_name>
      <phone>020143301</phone>
    </contact>
    <contact_backup>
      <last_name>Sarah Terjung</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Zentrum für Schlafmedizin Dr. Warmuth</name>
      <address>
        <city>Berlin</city>
        <zip>12683</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ralf Warmuth, Dr</last_name>
      <phone>03023254320</phone>
      <email>info@schlafdoktor.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</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>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Sleep Apnea, Central</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/NCT03043716
org study id: TelePAP_Protokoll_V02_17072017
nct id: NCT03043716
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and
      maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy
      on long-term outcomes.
Airway obstructions, airflow resistance by partial occlusion of the airways or central
      sleep-breathing disorders, where the respiratory effort is reduced or stops, cause a
      reduction in airflow and lead to arousals from sleep and disturbances in gas exchange during
      sleep. The negative consequences manifest in increases of blood pressure, higher workload for
      the heart and daytime sleepiness. PAP (positive airway pressure) treats sleep-related
      breathing disorders. It applies pressure to nose and mouth to keep the airway from collapsing
      and provides pressure support to assist the respiratory muscles. The efficacy of the therapy
      is measured with apnoea- and hypopnoea-indices that count the total number of apnoeic events
      at night. To ensure an efficacious and efficient therapy, pressures have to be adjusted
      correctly and the patient needs to use PAP regularly.

      Telemonitoring is information and communication technology to exchange sleep data and to
      provide clinical guidance over distances. There is no defined spectrum of technology. It can
      comprise phone calls, video support or interaction programs via the internet. Some studies
      point to advantages of telemonitoring in keeping compliance upright, increase usage hours and
      some also point to economic advantages. However, we do not have conclusive data from large
      trials with telemonitoring on the long-term that would show conclusive effects, be it from
      the side of a patient or from a cost and labour perspective of providers or the healthcare
      sector. Still, there are uncertainties regarding data safety, reimbursement or connectivity
      of different systems.

      No long-term data of PAP therapy under telemonitoring and its effect on compliance and
      therapy outcomes is available by now.
observational model: Cohort
time perspective: Prospective
measure: Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring
time frame: 24 months
description: Usage Patterns are hours/night and nights/month that therapy has been used. Telemonitoring enables the physician to remotely supervise device usage. Usage will be assessed through data recordings of the device: Days of usage >3hours; Days of usage <3 hours; total recorded days; mean daily usage (minutes); total usage hours (h)
measure: Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up
time frame: 24 months
description: Sleep disorders are snoring, insomnia, hypersomnia, depression, restless legs syndrome as assessed by anamnesis.
measure: Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up
time frame: 24 months
description: Efficacy is measured through changes in Apnea-Hypopnea-Index AHI (numbers of apneas - reduction of airflow by >90% for at least 10 seconds - and hypopneas - reduction of airflow by >30% for at least 10 seconds with a 4% decrease of Oxygen Saturation - divided by hours of sleep), AI - apnea index (apneas per hour), HI hypopnea index (hypopneas per hour).
measure: Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with the 24 months follow-up
time frame: 24 months
description: The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.
measure: Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up
time frame: 24 months
description: Possible causes for therapy Termination are assessed: Lost-to-follow-up, no interest in therapy, changed physician, no therapy benefits, Hospital stay, death
intervention type: Other
intervention name: PAP therapy with telemonitoring
description: Patients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Hartmut Grüger, Dr
role: Principal Investigator
affiliation: Grand Arc Düsseldorf
last name: Oliver Munt, Dr
phone: +49(0)1629056360
email: oliver.munt@resmed.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Sleep Apnea, Central