<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/NCT03007745</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 12-409</org_study_id>
    <nct_id>NCT03007745</nct_id>
  </id_info>
  <brief_title>Remote Sleep Apnea Management</brief_title>
  <official_title>Remote Ambulatory Management of Veterans With Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and&#xD;
      recognized as a major public health concern, most Veterans with this disorder are undiagnosed&#xD;
      and therefore untreated. Access to sleep laboratories for testing is limited particularly for&#xD;
      those Veterans living in rural areas and Veterans with disabilities that prevent travel to a&#xD;
      sleep center. The goal of this study is to compare a web-based telehealth management strategy&#xD;
      to in-person management. The telehealth pathway will enable Veterans to be diagnosed and&#xD;
      treated without visiting a sleep center. The investigators believe that telehealth management&#xD;
      will increase Veterans' access to this specialized care at a cost that is less than in-person&#xD;
      delivery but with similar improvements in daytime function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in&#xD;
      Veterans and is associated with an increased risk of hypertension, heart attacks, strokes,&#xD;
      depression, and driving accidents. Current in-person management at a sleep center limits&#xD;
      Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote&#xD;
      areas to travel long distances. This proposal will evaluate an innovative web-based clinical&#xD;
      pathway to diagnose and manage Veterans with OSA. In FY13, the investigative team received a&#xD;
      VHA Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a&#xD;
      personalized, interactive website that, when combined with other emerging telehealth&#xD;
      technologies, is designed to improve access to care, reduce patient wait times, and allow&#xD;
      Veterans to receive care without travelling to a sleep center. Veterans complete intake and&#xD;
      follow-up questionnaires on the REVAMP website and perform an unattended home sleep test&#xD;
      (HST) without in-person instructions. Sleep specialists review the findings with the patient&#xD;
      during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses&#xD;
      into templated progress notes that are exported to CPRS, the electronic medical record.&#xD;
      Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure&#xD;
      (APAP) units. These devices transmit data wirelessly to the website where treatment use and&#xD;
      its effectiveness can be monitored by both Veterans and practitioners, thereby promoting&#xD;
      patient self-management and productive patient-practitioner interactions.&#xD;
&#xD;
      The investigators' proposed prospective, randomized intervention will compare the clinical&#xD;
      and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1&#xD;
      will determine if management with REVAMP is clinically non-inferior to in-person care in&#xD;
      terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical&#xD;
      effectiveness following 3 months of APAP treatment will be expressed in terms of improvement&#xD;
      in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators'&#xD;
      primary outcome measure. Adherence to APAP will be objectively monitored by wireless&#xD;
      transmission of data from the participant's home unit. In Aim 2, patient preference, medical&#xD;
      service use and cost will be collected every 3 months for the entire observation period to&#xD;
      compare cost effectiveness of the two managements. Preference will be assessed by the SF-6D,6&#xD;
      and the EQ-5D.7, 8 Differences in the ratio of cost and quality-adjusted life years saved by&#xD;
      REVAMP compared to in-person management will test the hypothesis that REVAMP management will&#xD;
      have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to&#xD;
      support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use&#xD;
      qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance,&#xD;
      and patient satisfaction) to inform clinicians, administrators and other stakeholders how to&#xD;
      implement this innovative chronic disease pathway.&#xD;
&#xD;
      Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in&#xD;
      Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome&#xD;
      measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at&#xD;
      least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score.&#xD;
      Analysis will also compare the mean daily hours of APAP use in participants in the two groups&#xD;
      initiated on APAP treatment.&#xD;
&#xD;
      Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP&#xD;
      management will be no more than one point less than that in participants receiving in-person&#xD;
      management.&#xD;
&#xD;
      Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management&#xD;
      will be no more than 0.75 hour less than that in participants randomized to in-person&#xD;
      management.&#xD;
&#xD;
      Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY)&#xD;
      between REVAMP management and in-person management. The perspective of the analysis will be&#xD;
      that of the VA and the intention to treat analysis set will include all randomized&#xD;
      participants.&#xD;
&#xD;
      Hypothesis 2a: Average total health-care delivery cost will be lower for participants&#xD;
      receiving REVAMP compared to in-person management.&#xD;
&#xD;
      Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP&#xD;
      manage-ment will be &gt; $100,000 (i.e., the investigators will have 90% confidence that REVAMP&#xD;
      is good value for the cost).&#xD;
&#xD;
      Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's&#xD;
      widespread implementation. Quantitative component: The investigators will track quantitative&#xD;
      outcome measures across both groups including attrition, participant- and practitioner-rated&#xD;
      therapeutic alliance (Working Alliance Inventory-Short Revised [WAI-SR]),9 and participant&#xD;
      treatment satisfaction (Client Satisfaction Questionnaire [CSQ-8]).10 The investigators will&#xD;
      compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms.&#xD;
      Qualitative component: The investigators will explore participant- and practitioner-level&#xD;
      perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as&#xD;
      well as barriers and facilitators to participation in either clinical pathway through phone&#xD;
      interviews with participants from the two intervention groups, participants who withdraw from&#xD;
      either intervention, and staff who provide care through REVAMP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-administered disease specific quality of life questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-administered subjective measure of daytime sleepiness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heath Survey Short Form - 12 (SF-12)</measure>
    <time_frame>3 months</time_frame>
    <description>Self administered quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies Depression questionnaire (CES-D)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-administered assessment of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-administered assessment of insomnia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utilities Index (HUI)</measure>
    <time_frame>3 months to 2.5 years</time_frame>
    <description>Self-administered questionnaire on overall functional health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol</measure>
    <time_frame>3 months to 2.5 years</time_frame>
    <description>Self-administered questionnaire on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worker Alliance Inventory - Short Revised (WAI-SR)</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of patient-rated alliance with the practitioner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-administered questionnaire assessing patient satisfaction with care delivered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to autoadjusting CPAP treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Objective assessment of treatment adherence and efficacy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">435</enrollment>
  <condition>Sleep Apnea - Obstructive</condition>
  <condition>Cost Effectiveness</condition>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>REVAMP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-person management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>autoadjusting continuous positive airway pressure</intervention_name>
    <description>Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure</description>
    <arm_group_label>In-person management</arm_group_label>
    <arm_group_label>REVAMP</arm_group_label>
    <other_name>APAP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Veterans must meet the following inclusion criteria prior to enrollment:&#xD;
&#xD;
          -  Referral to one of the participating sleep centers for evaluation of suspected OSA&#xD;
&#xD;
          -  Access in the home to the internet, e-mail, and phone on all days&#xD;
&#xD;
          -  Fluent in English as assessed on the initial phone contact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Veterans will be excluded from the study for the following reasons:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent and complete required questionnaires&#xD;
&#xD;
          -  Previous diagnosis of:&#xD;
&#xD;
               -  obstructive sleep apnea (OSA)&#xD;
&#xD;
               -  central sleep apnea (50% of apneas on diagnostic testing are central apneas)&#xD;
&#xD;
               -  Cheyne-Stokes breathing&#xD;
&#xD;
               -  obesity hypoventilation syndrome&#xD;
&#xD;
               -  narcolepsy&#xD;
&#xD;
          -  Previous treatment with positive airway pressure, non-nasal surgery for OSA, or&#xD;
             current use of supplemental oxygen&#xD;
&#xD;
          -  A clinically unstable medical condition in the previous 2 months as defined by a new&#xD;
             diagnosis, e.g.:&#xD;
&#xD;
               -  pneumonia&#xD;
&#xD;
               -  myocardial infarction&#xD;
&#xD;
               -  congestive heart failure&#xD;
&#xD;
               -  unstable angina&#xD;
&#xD;
               -  thyroid disease&#xD;
&#xD;
               -  depression or psychosis&#xD;
&#xD;
               -  ventricular arrhythmias&#xD;
&#xD;
               -  cirrhosis&#xD;
&#xD;
               -  surgery&#xD;
&#xD;
               -  recently diagnosed cancer&#xD;
&#xD;
          -  Night shift workers in situations or occupations where they regularly experience jet&#xD;
             lag, or have irregular work schedules by history over the last 3 months&#xD;
&#xD;
          -  Women who are pregnant or women who are sexually active and of child-bearing age who&#xD;
             are not using some form of contraceptive&#xD;
&#xD;
          -  Unable to perform tests due to inability to communicate verbally, inability to read&#xD;
             and write, and visual, hearing or cognitive impairment&#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>Samuel T. Kuna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9;44(4):zsaa243. doi: 10.1093/sleep/zsaa243.</citation>
    <PMID>33216916</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Continuous positive airway pressure</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>
  </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/NCT03007745
org study id: IIR 12-409
nct id: NCT03007745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and
      recognized as a major public health concern, most Veterans with this disorder are undiagnosed
      and therefore untreated. Access to sleep laboratories for testing is limited particularly for
      those Veterans living in rural areas and Veterans with disabilities that prevent travel to a
      sleep center. The goal of this study is to compare a web-based telehealth management strategy
      to in-person management. The telehealth pathway will enable Veterans to be diagnosed and
      treated without visiting a sleep center. The investigators believe that telehealth management
      will increase Veterans' access to this specialized care at a cost that is less than in-person
      delivery but with similar improvements in daytime function.
Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in
      Veterans and is associated with an increased risk of hypertension, heart attacks, strokes,
      depression, and driving accidents. Current in-person management at a sleep center limits
      Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote
      areas to travel long distances. This proposal will evaluate an innovative web-based clinical
      pathway to diagnose and manage Veterans with OSA. In FY13, the investigative team received a
      VHA Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a
      personalized, interactive website that, when combined with other emerging telehealth
      technologies, is designed to improve access to care, reduce patient wait times, and allow
      Veterans to receive care without travelling to a sleep center. Veterans complete intake and
      follow-up questionnaires on the REVAMP website and perform an unattended home sleep test
      (HST) without in-person instructions. Sleep specialists review the findings with the patient
      during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses
      into templated progress notes that are exported to CPRS, the electronic medical record.
      Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure
      (APAP) units. These devices transmit data wirelessly to the website where treatment use and
      its effectiveness can be monitored by both Veterans and practitioners, thereby promoting
      patient self-management and productive patient-practitioner interactions.

      The investigators' proposed prospective, randomized intervention will compare the clinical
      and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1
      will determine if management with REVAMP is clinically non-inferior to in-person care in
      terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical
      effectiveness following 3 months of APAP treatment will be expressed in terms of improvement
      in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators'
      primary outcome measure. Adherence to APAP will be objectively monitored by wireless
      transmission of data from the participant's home unit. In Aim 2, patient preference, medical
      service use and cost will be collected every 3 months for the entire observation period to
      compare cost effectiveness of the two managements. Preference will be assessed by the SF-6D,6
      and the EQ-5D.7, 8 Differences in the ratio of cost and quality-adjusted life years saved by
      REVAMP compared to in-person management will test the hypothesis that REVAMP management will
      have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to
      support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use
      qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance,
      and patient satisfaction) to inform clinicians, administrators and other stakeholders how to
      implement this innovative chronic disease pathway.

      Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in
      Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome
      measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at
      least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score.
      Analysis will also compare the mean daily hours of APAP use in participants in the two groups
      initiated on APAP treatment.

      Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP
      management will be no more than one point less than that in participants receiving in-person
      management.

      Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management
      will be no more than 0.75 hour less than that in participants randomized to in-person
      management.

      Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY)
      between REVAMP management and in-person management. The perspective of the analysis will be
      that of the VA and the intention to treat analysis set will include all randomized
      participants.

      Hypothesis 2a: Average total health-care delivery cost will be lower for participants
      receiving REVAMP compared to in-person management.

      Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP
      manage-ment will be > $100,000 (i.e., the investigators will have 90% confidence that REVAMP
      is good value for the cost).

      Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's
      widespread implementation. Quantitative component: The investigators will track quantitative
      outcome measures across both groups including attrition, participant- and practitioner-rated
      therapeutic alliance (Working Alliance Inventory-Short Revised [WAI-SR]),9 and participant
      treatment satisfaction (Client Satisfaction Questionnaire [CSQ-8]).10 The investigators will
      compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms.
      Qualitative component: The investigators will explore participant- and practitioner-level
      perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as
      well as barriers and facilitators to participation in either clinical pathway through phone
      interviews with participants from the two intervention groups, participants who withdraw from
      either intervention, and staff who provide care through REVAMP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)
time frame: 3 months
description: Self-administered disease specific quality of life questionnaire
measure: Epworth Sleepiness Scale (ESS)
time frame: 3 months
description: Self-administered subjective measure of daytime sleepiness
measure: Heath Survey Short Form - 12 (SF-12)
time frame: 3 months
description: Self administered quality of life questionnaire
measure: Center for Epidemiological Studies Depression questionnaire (CES-D)
time frame: 3 months
description: Self-administered assessment of depression
measure: Insomnia Severity Index (ISI)
time frame: 3 months
description: Self-administered assessment of insomnia
measure: Health Utilities Index (HUI)
time frame: 3 months to 2.5 years
description: Self-administered questionnaire on overall functional health
measure: EuroQol
time frame: 3 months to 2.5 years
description: Self-administered questionnaire on quality of life
measure: Worker Alliance Inventory - Short Revised (WAI-SR)
time frame: 3 months
description: Assessment of patient-rated alliance with the practitioner
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: 3 months
description: Self-administered questionnaire assessing patient satisfaction with care delivered
measure: Adherence to autoadjusting CPAP treatment
time frame: 3 months
description: Objective assessment of treatment adherence and efficacy
arm group label: REVAMP
arm group type: Experimental
description: Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
arm group label: In-person management
arm group type: Active Comparator
description: Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
intervention type: Device
intervention name: autoadjusting continuous positive airway pressure
description: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
arm group label: In-person management
arm group label: REVAMP
other name: APAP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel T. Kuna, MD
role: Principal Investigator
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
facility: 
facility: 
facility: 
country: United States
citation: Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9;44(4):zsaa243. doi: 10.1093/sleep/zsaa243.
PMID: 33216916
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
sharing ipd: No