xml: <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/NCT06042686</url>
    </required_header>
    <id_info>
      <org_study_id>2096</org_study_id>
      <nct_id>NCT06042686</nct_id>
    </id_info>
    <brief_title>Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems</brief_title>
    <official_title>Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Massachusetts, Amherst</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Massachusetts, Amherst</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Venous thromboembolism is prevalent, associated with a high degree of morbidity and&#xD;
        mortality, and largely preventable. External mechanical compression is a standard of care for&#xD;
        prevention, but compliance with traditional external mechanical compression devices is low&#xD;
        due to patient reported issues with comfort, mobility, usability, noise, and sleep&#xD;
        disturbances. The purpose of this study was to compare user-rated comfort, mobility,&#xD;
        usability, noise, perceived sleep disturbance, and objective sleep disturbance for a novel&#xD;
        external lower limb mechanical compression device as compared to a standard sequential&#xD;
        compression device.&#xD;
  &#xD;
        Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore&#xD;
        two mechanical compression devices, the commonly-used Kendall sequential compression device&#xD;
        Express 9525 and the novel Recovery Force Movement and Compressions Device for 1 night each&#xD;
        in their home while sleep was recorded with polysomnography. For each device, participants&#xD;
        also completed questionnaires to assess usability, mobility, perceived noise disturbance, and&#xD;
        perceived sleep disturbance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recruitment&#xD;
  &#xD;
          1. Respondents are solicited via social media/local flyer campaigns (see attached flyers),&#xD;
             or word of mouth (see Recruitment via Word of Mouth) to complete a brief, electronic&#xD;
             pre-screening survey powered by REDCap software, or to set up a phone call to review&#xD;
             study eligibility if preferred.&#xD;
  &#xD;
          2. Recruiter responds to eligible or interested Respondents as described in Recruitment&#xD;
             Attachments (i.e., Recruitment Email Script).&#xD;
  &#xD;
          3. Recruiter coordinates a phone interview with interested and eligible Respondents to&#xD;
             confirm eligibility criteria and review the Informed Consent Form with the Respondent in&#xD;
             real time over the phone, while the Respondent follows along with a secure REDCap&#xD;
             Informed Consent survey to capture an electronic signature.&#xD;
  &#xD;
          4. Consenting Participants will submit the Informed Consent form electronically, receive a&#xD;
             .pdf copy of their completed (signed) Informed Consent form, and be prompted to complete&#xD;
             a subsequent electronic Contact Information Questionnaire, which will only be accessible&#xD;
             within the REDCap server by authorized study personnel, e.g. PI and Recruitment&#xD;
             Coordinator. A electronic COVID-19 Vaccination Status Confirmation Form will also be&#xD;
             completed at this time, including a single upload field for a digital image of the&#xD;
             participant's vaccination card. This image will be visually inspected by the Recruiter&#xD;
             and immediately deleted from the REDCap server.&#xD;
  &#xD;
          5. The Recruiter will manually assign the Participant a coded record ID and follow-up with&#xD;
             the Participant via phone or email for tentative scheduling of equipment delivery and&#xD;
             data collection through the full protocol. Scheduling will be confirmed with&#xD;
             Participants in the week leading up to each transport event.&#xD;
  &#xD;
          6. Prior to scheduled data collection, all consenting participants will be screened in&#xD;
             their homes for undetected deep vein thrombosis using mobile doppler ultrasound while&#xD;
             following all COVID-19 guidelines. Any participant who screens in positive for deep vein&#xD;
             thrombosis will be withdrawn from the study.&#xD;
  &#xD;
        Study Procedures&#xD;
  &#xD;
          1. Once interested respondents have completed all pre-screening, informed consent process&#xD;
             will be completed. The voluntary nature of the research will be stressed, participants&#xD;
             will have the opportunity to have all of their questions answered, and they will be&#xD;
             reminded that they can withdraw their consent at any time.&#xD;
  &#xD;
          2. Once consent has been executed and subsequent enrollment forms completed, participants&#xD;
             will be scheduled for their deep vein thrombosis screening, their sleep monitoring data&#xD;
             collection nights, and their equipment delivery.&#xD;
  &#xD;
          3. Participants will then be randomized to receive either the Kendall® or RF Health System&#xD;
             on data collection night 1&#xD;
  &#xD;
          4. Due to the COVID-19 outbreak, UMass researchers will transport the all study equipment&#xD;
             to and from the participants residences using all COVID-19 guidelines and will disinfect&#xD;
             all materials at the UMass Sleep Monitoring Laboratory between uses.&#xD;
  &#xD;
          5. To ensure high-quality data acquisition, researchers will video conference with&#xD;
             participants at prescheduled times, approximately 1-hour prior to participants typical&#xD;
             bedtime to provide real-time, remote guidance for proper self-application of the Sleep&#xD;
             Profiler headset, Kendall and RF Health System. The first of these sessions will take&#xD;
             place shortly after the scheduled deep vein thrombosis screening session. The&#xD;
             teleconferencing will take not more of the participant's time than a typical, in-person&#xD;
             application.&#xD;
  &#xD;
          6. At the conclusion of their first overnight sleep profiler data collection (via Sleep&#xD;
             Profiler headset, see attached Technical Manual) while using one of the leg compression&#xD;
             devices, participants will be asked to complete their self-report measures in the&#xD;
             following order: PROMIS Sleep Disturbance Form 6a, Comfort Rating Scale, Environmental&#xD;
             Comfort Scale, System Usability Scale, and Task Load Index.&#xD;
  &#xD;
          7. There will be at least one night without any devices between data collection nights 1 &amp;&#xD;
             2.&#xD;
  &#xD;
          8. All study procedures will be repeated on data collection overnight 2 using the other&#xD;
             external compression device.&#xD;
  &#xD;
          9. Once data collection for night 2 has been completed, all participants will be asked if&#xD;
             they have any further questions and all questions will be addressed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">July 1, 2022</completion_date>
    <primary_completion_date type="Actual">March 2, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Repeated measures study design where each participant gets both devices on different nights in random order</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measure the impact of external mechanical compression on overall sleep.</measure>
      <time_frame>4 Months</time_frame>
      <description>Overall sleep will be measured using the Sleep Profiler. The Sleep Profiler is a battery powered portable device that provides a measure of the percentage of overall sleep vs wake in a given period of time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the comfort associated with mechanical compression between the two devices.</measure>
      <time_frame>4 months</time_frame>
      <description>After each night of sleep, participants will provide their self-report on comfort using the Comfort Rating Scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the noise associated with mechanical compression between the two devices.</measure>
      <time_frame>4 months</time_frame>
      <description>After each night of sleep, participants will provide their self-report on noise using the Environmental Comfort Scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the usability associated with mechanical compression between the two devices.</measure>
      <time_frame>4 months</time_frame>
      <description>After each night of sleep, participants will provide their self-report on usability using the System Usability Scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the perceived sleep disturbance associated with mechanical compression between the two devices.</measure>
      <time_frame>4 months</time_frame>
      <description>After each night of sleep, participants will provide their self-report on sleep disturbance using the PROMIS Sleep Disturbance: Short Form 8a.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Deep Venous Thrombosis of Deep Femoral Vein</condition>
    <arm_group>
      <arm_group_label>Repeated measures</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RF Health MAC Device</intervention_name>
      <description>Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.</description>
      <arm_group_label>Repeated measures</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            -  Adult participants age 50-75&#xD;
  &#xD;
            -  BMI 18-39&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  BMI or age outside of the inclusion criteria limits&#xD;
  &#xD;
            -  stomach-sleepers&#xD;
  &#xD;
            -  uncontrolled asthma&#xD;
  &#xD;
            -  surgery within the past 6 weeks&#xD;
  &#xD;
            -  history of venous thrombosis within the past 12 months&#xD;
  &#xD;
            -  abnormalities of the lower extremities, including edema, deformity which does not&#xD;
               allow for proper fit of the external mechanical compression devices&#xD;
  &#xD;
            -  skin breakdown of any kind&#xD;
  &#xD;
            -  severe peripheral neuropathy&#xD;
  &#xD;
            -  skin grafting within the last 3 months, cellulitis or dermatitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Massachusetts Amherst</name>
        <address>
          <city>Amherst</city>
          <state>Massachusetts</state>
          <zip>01003</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Thrombosis</mesh_term>
      <mesh_term>Venous Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042686
  org study id: 2096
  nct id: NCT06042686
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Venous thromboembolism is prevalent, associated with a high degree of morbidity and
        mortality, and largely preventable. External mechanical compression is a standard of care for
        prevention, but compliance with traditional external mechanical compression devices is low
        due to patient reported issues with comfort, mobility, usability, noise, and sleep
        disturbances. The purpose of this study was to compare user-rated comfort, mobility,
        usability, noise, perceived sleep disturbance, and objective sleep disturbance for a novel
        external lower limb mechanical compression device as compared to a standard sequential
        compression device.
  
        Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore
        two mechanical compression devices, the commonly-used Kendall sequential compression device
        Express 9525 and the novel Recovery Force Movement and Compressions Device for 1 night each
        in their home while sleep was recorded with polysomnography. For each device, participants
        also completed questionnaires to assess usability, mobility, perceived noise disturbance, and
        perceived sleep disturbance.
  Recruitment
  
          1. Respondents are solicited via social media/local flyer campaigns (see attached flyers),
             or word of mouth (see Recruitment via Word of Mouth) to complete a brief, electronic
             pre-screening survey powered by REDCap software, or to set up a phone call to review
             study eligibility if preferred.
  
          2. Recruiter responds to eligible or interested Respondents as described in Recruitment
             Attachments (i.e., Recruitment Email Script).
  
          3. Recruiter coordinates a phone interview with interested and eligible Respondents to
             confirm eligibility criteria and review the Informed Consent Form with the Respondent in
             real time over the phone, while the Respondent follows along with a secure REDCap
             Informed Consent survey to capture an electronic signature.
  
          4. Consenting Participants will submit the Informed Consent form electronically, receive a
             .pdf copy of their completed (signed) Informed Consent form, and be prompted to complete
             a subsequent electronic Contact Information Questionnaire, which will only be accessible
             within the REDCap server by authorized study personnel, e.g. PI and Recruitment
             Coordinator. A electronic COVID-19 Vaccination Status Confirmation Form will also be
             completed at this time, including a single upload field for a digital image of the
             participant's vaccination card. This image will be visually inspected by the Recruiter
             and immediately deleted from the REDCap server.
  
          5. The Recruiter will manually assign the Participant a coded record ID and follow-up with
             the Participant via phone or email for tentative scheduling of equipment delivery and
             data collection through the full protocol. Scheduling will be confirmed with
             Participants in the week leading up to each transport event.
  
          6. Prior to scheduled data collection, all consenting participants will be screened in
             their homes for undetected deep vein thrombosis using mobile doppler ultrasound while
             following all COVID-19 guidelines. Any participant who screens in positive for deep vein
             thrombosis will be withdrawn from the study.
  
        Study Procedures
  
          1. Once interested respondents have completed all pre-screening, informed consent process
             will be completed. The voluntary nature of the research will be stressed, participants
             will have the opportunity to have all of their questions answered, and they will be
             reminded that they can withdraw their consent at any time.
  
          2. Once consent has been executed and subsequent enrollment forms completed, participants
             will be scheduled for their deep vein thrombosis screening, their sleep monitoring data
             collection nights, and their equipment delivery.
  
          3. Participants will then be randomized to receive either the Kendall® or RF Health System
             on data collection night 1
  
          4. Due to the COVID-19 outbreak, UMass researchers will transport the all study equipment
             to and from the participants residences using all COVID-19 guidelines and will disinfect
             all materials at the UMass Sleep Monitoring Laboratory between uses.
  
          5. To ensure high-quality data acquisition, researchers will video conference with
             participants at prescheduled times, approximately 1-hour prior to participants typical
             bedtime to provide real-time, remote guidance for proper self-application of the Sleep
             Profiler headset, Kendall and RF Health System. The first of these sessions will take
             place shortly after the scheduled deep vein thrombosis screening session. The
             teleconferencing will take not more of the participant's time than a typical, in-person
             application.
  
          6. At the conclusion of their first overnight sleep profiler data collection (via Sleep
             Profiler headset, see attached Technical Manual) while using one of the leg compression
             devices, participants will be asked to complete their self-report measures in the
             following order: PROMIS Sleep Disturbance Form 6a, Comfort Rating Scale, Environmental
             Comfort Scale, System Usability Scale, and Task Load Index.
  
          7. There will be at least one night without any devices between data collection nights 1 &
             2.
  
          8. All study procedures will be repeated on data collection overnight 2 using the other
             external compression device.
  
          9. Once data collection for night 2 has been completed, all participants will be asked if
             they have any further questions and all questions will be addressed.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Repeated measures study design where each participant gets both devices on different nights in random order
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Measure the impact of external mechanical compression on overall sleep.
  time frame: 4 Months
  description: Overall sleep will be measured using the Sleep Profiler. The Sleep Profiler is a battery powered portable device that provides a measure of the percentage of overall sleep vs wake in a given period of time.
  measure: Compare the comfort associated with mechanical compression between the two devices.
  time frame: 4 months
  description: After each night of sleep, participants will provide their self-report on comfort using the Comfort Rating Scale.
  measure: Compare the noise associated with mechanical compression between the two devices.
  time frame: 4 months
  description: After each night of sleep, participants will provide their self-report on noise using the Environmental Comfort Scale.
  measure: Compare the usability associated with mechanical compression between the two devices.
  time frame: 4 months
  description: After each night of sleep, participants will provide their self-report on usability using the System Usability Scale.
  measure: Compare the perceived sleep disturbance associated with mechanical compression between the two devices.
  time frame: 4 months
  description: After each night of sleep, participants will provide their self-report on sleep disturbance using the PROMIS Sleep Disturbance: Short Form 8a.
  arm group label: Repeated measures
  arm group type: Other
  description: Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.
  intervention type: Device
  intervention name: RF Health MAC Device
  description: Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.
  arm group label: Repeated measures
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Thrombosis
  mesh term: Venous Thrombosis
  sharing ipd: No