<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/NCT01716676</url>
  </required_header>
  <id_info>
    <org_study_id>SEPAR-PII2011</org_study_id>
    <nct_id>NCT01716676</nct_id>
  </id_info>
  <brief_title>Telemedicine in Sleep Breathing Disorders: a Multicenter Study.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <brief_summary>
    <textblock>
      In recent years medicine has been enhanced by the incorporation of technological innovations&#xD;
      from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering.&#xD;
      One of the few exceptions in this rapid process of implementing technological advances occurs&#xD;
      in clinical medicine, where its penetration is much less effective than in other scientific&#xD;
      and professional fields, or even in everyday life. Attempts to tackle this problem have given&#xD;
      rise to various initiatives in the US and Europe, including Spain.&#xD;
&#xD;
      There is a surprising paucity of telemedicine systems in clinical practice, especially with&#xD;
      respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea&#xD;
      (OSA), where protocols are urgently needed to alleviate this healthcare problem represented&#xD;
      by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In&#xD;
      others words, the growing awareness of sleep disorders, especially OSA, has not been&#xD;
      accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these&#xD;
      diseases.&#xD;
&#xD;
      CPAP therapy compliance is not always appropriate. Helping patients during the first two&#xD;
      months usually determines compliance. Therefore, the development of strategies to support the&#xD;
      patient during the first weeks is essential. However, this &quot;collides&quot; with reality, where it&#xD;
      is difficult to properly care all patients because of congested sleep units. It is therefore&#xD;
      necessary to implement new and imaginative control schemes especially at the beginning of the&#xD;
      treatment. Patients' follow-up performed by telemedicine technology is an option that aims to&#xD;
      substitute the face-to-face visits or at least reduce them considerably. In a future context,&#xD;
      the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda&#xD;
      face-to-face visits and televisits (at distance) and information which patient will provide&#xD;
      through online questionnaires with a certain frequency.&#xD;
&#xD;
      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients&#xD;
      monitored by telemedicine techniques (website and televisits) is similar to that achieved by&#xD;
      standard monitoring but more cost-effective. The study design is a multicenter randomized&#xD;
      trial with parallel groups and blind final evaluation after CPAP treatment following two&#xD;
      different strategies: one through conventional monitoring in the hospital (face-to-face&#xD;
      visiting) and another by telemedicine monitoring (non-contact visiting and website).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>CPAP compliance</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Standard CPAP follow-up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine CPAP follow-up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine CPAP monitoring (webpage and televisit)</intervention_name>
    <arm_group_label>Telemedicine CPAP follow-up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard CPAP monitoring</intervention_name>
    <arm_group_label>Standard CPAP follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of OSA;&#xD;
&#xD;
          -  18-75 years;&#xD;
&#xD;
          -  CPAP recommendation;&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disabling hypersomnia;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Psychiatric disorders;&#xD;
&#xD;
          -  Previous treatment with CPAP;&#xD;
&#xD;
          -  Clinical instability in the previous month;&#xD;
&#xD;
          -  Inability to use information technologies (computers and web).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2014</last_update_posted>
  <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>
  </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/NCT01716676
org study id: SEPAR-PII2011
nct id: NCT01716676
lead sponsor: 
In recent years medicine has been enhanced by the incorporation of technological innovations
      from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering.
      One of the few exceptions in this rapid process of implementing technological advances occurs
      in clinical medicine, where its penetration is much less effective than in other scientific
      and professional fields, or even in everyday life. Attempts to tackle this problem have given
      rise to various initiatives in the US and Europe, including Spain.

      There is a surprising paucity of telemedicine systems in clinical practice, especially with
      respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea
      (OSA), where protocols are urgently needed to alleviate this healthcare problem represented
      by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In
      others words, the growing awareness of sleep disorders, especially OSA, has not been
      accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these
      diseases.

      CPAP therapy compliance is not always appropriate. Helping patients during the first two
      months usually determines compliance. Therefore, the development of strategies to support the
      patient during the first weeks is essential. However, this "collides" with reality, where it
      is difficult to properly care all patients because of congested sleep units. It is therefore
      necessary to implement new and imaginative control schemes especially at the beginning of the
      treatment. Patients' follow-up performed by telemedicine technology is an option that aims to
      substitute the face-to-face visits or at least reduce them considerably. In a future context,
      the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda
      face-to-face visits and televisits (at distance) and information which patient will provide
      through online questionnaires with a certain frequency.

      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients
      monitored by telemedicine techniques (website and televisits) is similar to that achieved by
      standard monitoring but more cost-effective. The study design is a multicenter randomized
      trial with parallel groups and blind final evaluation after CPAP treatment following two
      different strategies: one through conventional monitoring in the hospital (face-to-face
      visiting) and another by telemedicine monitoring (non-contact visiting and website).
measure: CPAP compliance
time frame: 6 months
measure: Cost-effectiveness
time frame: 6 months
measure: Quality of life
time frame: 6 months
arm group label: Standard CPAP follow-up
arm group type: Active Comparator
arm group label: Telemedicine CPAP follow-up
arm group type: Experimental
intervention type: Other
intervention name: Telemedicine CPAP monitoring (webpage and televisit)
arm group label: Telemedicine CPAP follow-up
intervention type: Other
intervention name: Standard CPAP monitoring
arm group label: Standard CPAP follow-up
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Spain
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive