<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/NCT01715194</url>
  </required_header>
  <id_info>
    <org_study_id>EKSG 12/076</org_study_id>
    <nct_id>NCT01715194</nct_id>
  </id_info>
  <brief_title>Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS</brief_title>
  <official_title>Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otto D. Schoch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize that the use of telemedicine combined with support interventions by short&#xD;
      messages, telephone calls and ambulatory visits to control CPAP treatment during the first&#xD;
      month improves adherence and reduces unresolved side effects of therapy.&#xD;
&#xD;
      The primary objective of an OSAS treatment program is to successfully implement indicated&#xD;
      CPAP in the highest possible proportion of patients in order to lower the proportion of&#xD;
      untreated OSAS in the population. On an individual basis, it has been shown that a longer&#xD;
      duration of CPAP use is associated with better outcomes in terms of daytime functioning and&#xD;
      in the control of metabolic and blood pressure effects of CPAP. For our study, we have&#xD;
      therefore decided to use 2 co-primary endpoints, taking into account both aspects of&#xD;
      adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.&#xD;
      Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.&#xD;
      We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive&#xD;
      impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months</measure>
    <time_frame>at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of nights with efficient CPAP use (defined as ≥4h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months</measure>
    <time_frame>at 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP)</measure>
    <time_frame>at 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month</measure>
    <time_frame>at 1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1)</measure>
    <time_frame>at 1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of efficient CPAP users (defined as ≥4h of CPAP use per night within the last week including nights of no-use of CPAP) at 1 month</measure>
    <time_frame>at 1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP)</measure>
    <time_frame>at 1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mask leakage at 1 and 6 months</measure>
    <time_frame>at 1 and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse effects on CPAP at 1 and 6 months</measure>
    <time_frame>at 1 and 6 months</time_frame>
    <description>The proportion of patients with insomnia/dyssomnia due to CPAP, skin problems due to the mask, oronasal dryness or other treatment related complaints is assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months</measure>
    <time_frame>at 1 and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis.</measure>
    <time_frame>at 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiovascular risk factors in serum (e.g. cholesterol, C-peptid, ...), blood pressure and night time assessment of sleep quality with the novel assessment tool &quot;SOMNOcheck micro&quot;.</measure>
    <time_frame>at 1 and 6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Telemedicine intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if&#xD;
CPAP was used &lt;4h/ night for 2 consecutive night&#xD;
the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (without telemedicine)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine intervention</intervention_name>
    <description>Patients undergoing telemedicine intervention</description>
    <arm_group_label>Telemedicine intervention</arm_group_label>
    <other_name>ResMed Telemedicine S9 Wireless-Modul</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of &gt;5/h&#xD;
             in polysomnography (PSG) consenting to start longterm CPAP treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Unable to communicate in German, English, French or Italian&#xD;
&#xD;
          -  Alcohol consumption &gt; 4 units &gt;4 times a week&#xD;
&#xD;
          -  Acute manifestation of psychiatric diseases&#xD;
&#xD;
          -  Life expectancy of &lt; 6 months for any reason&#xD;
&#xD;
          -  Surgical obesity treatment planned within the next 6 months&#xD;
&#xD;
          -  Predominantly Central sleep apnea and cheyne stokes respiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Brutsche, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cantonal Hospital St. Gallen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cantonal Hospital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <state>CH</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.</citation>
    <PMID>20880872</PMID>
  </reference>
  <reference>
    <citation>Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.</citation>
    <PMID>15319046</PMID>
  </reference>
  <reference>
    <citation>Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.</citation>
    <PMID>16796496</PMID>
  </reference>
  <reference>
    <citation>Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.</citation>
    <PMID>17513285</PMID>
  </reference>
  <reference>
    <citation>Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.</citation>
    <PMID>20978030</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>July 25, 2016</last_update_submitted>
  <last_update_submitted_qc>July 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
    <investigator_full_name>Otto D. Schoch</investigator_full_name>
    <investigator_title>Sponsor investigator</investigator_title>
  </responsible_party>
  <keyword>OSAS</keyword>
  <keyword>CPAP</keyword>
  <keyword>Adherence</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01715194
org study id: EKSG 12/076
nct id: NCT01715194
lead sponsor: 
has dmc: No
We hypothesize that the use of telemedicine combined with support interventions by short
      messages, telephone calls and ambulatory visits to control CPAP treatment during the first
      month improves adherence and reduces unresolved side effects of therapy.

      The primary objective of an OSAS treatment program is to successfully implement indicated
      CPAP in the highest possible proportion of patients in order to lower the proportion of
      untreated OSAS in the population. On an individual basis, it has been shown that a longer
      duration of CPAP use is associated with better outcomes in terms of daytime functioning and
      in the control of metabolic and blood pressure effects of CPAP. For our study, we have
      therefore decided to use 2 co-primary endpoints, taking into account both aspects of
      adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.
      Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.
      We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive
      impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months
time frame: at 6 months
measure: Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1)
time frame: at 6 months
measure: Proportion of nights with efficient CPAP use (defined as ≥4h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months
time frame: at 6 months
measure: Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP)
time frame: at 6 months
measure: Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month
time frame: at 1 month
measure: Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1)
time frame: at 1 month
measure: Proportion of efficient CPAP users (defined as ≥4h of CPAP use per night within the last week including nights of no-use of CPAP) at 1 month
time frame: at 1 month
measure: Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP)
time frame: at 1 month
measure: Mask leakage at 1 and 6 months
time frame: at 1 and 6 months
measure: Adverse effects on CPAP at 1 and 6 months
time frame: at 1 and 6 months
description: The proportion of patients with insomnia/dyssomnia due to CPAP, skin problems due to the mask, oronasal dryness or other treatment related complaints is assessed.
measure: Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months
time frame: at 1 and 6 months
measure: Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis.
time frame: at 6 months
measure: Cardiovascular risk factors in serum (e.g. cholesterol, C-peptid, ...), blood pressure and night time assessment of sleep quality with the novel assessment tool "SOMNOcheck micro".
time frame: at 1 and 6 months
arm group label: Telemedicine intervention
arm group type: Active Comparator
description: In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if
CPAP was used <4h/ night for 2 consecutive night
the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4).
arm group label: Control (without telemedicine)
arm group type: No Intervention
description: In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use.
intervention type: Device
intervention name: Telemedicine intervention
description: Patients undergoing telemedicine intervention
arm group label: Telemedicine intervention
other name: ResMed Telemedicine S9 Wireless-Modul
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Brutsche, MD, PhD
role: Study Director
affiliation: Cantonal Hospital St. Gallen
facility: 
country: Switzerland
citation: Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
PMID: 20880872
citation: Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.
PMID: 15319046
citation: Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.
PMID: 16796496
citation: Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
PMID: 17513285
citation: Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.
PMID: 20978030
responsible party type: Sponsor-Investigator
investigator affiliation: Cantonal Hospital of St. Gallen
investigator full name: Otto D. Schoch
investigator title: Sponsor investigator
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome
sharing ipd: No