<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/NCT03837249</url>
  </required_header>
  <id_info>
    <org_study_id>2018-5225</org_study_id>
    <nct_id>NCT03837249</nct_id>
  </id_info>
  <brief_title>Self-Management of Sleep Among Older Adults</brief_title>
  <official_title>Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the feasibility of older persons use of a personal sleep&#xD;
      monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to&#xD;
      50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively&#xD;
      influences subjective and objective health outcomes.To improve their sleep, older adults with&#xD;
      chronic health conditions could benefit from objective information, available through&#xD;
      personal health monitoring devices, about their current and changing sleep patterns. Based on&#xD;
      this information, sleep self-management interventions can be individualized and shared, and&#xD;
      associations between sleep and health changes may be better managed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Comparative control - 3 group</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>One group - personal sleep monitoring data with-held then provided after the intervention period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Use of A Personal Sleep Monitoring Device (PSMD)</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Sleep</measure>
    <time_frame>Week 1 and Week 4</time_frame>
    <description>Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Health</measure>
    <time_frame>Week 1 and Week 4</time_frame>
    <description>Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability of PSMD</measure>
    <time_frame>Week 2 and 4</time_frame>
    <description>Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>Passive Personal Sleep Monitoring</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Personal Sleep Monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Socially Supported Sleep Monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Personal Sleep Monitoring</intervention_name>
    <description>Wearable Sleep Self-Monitoring Device (Actigraphy)</description>
    <arm_group_label>Individual Personal Sleep Monitoring</arm_group_label>
    <arm_group_label>Passive Personal Sleep Monitoring</arm_group_label>
    <arm_group_label>Socially Supported Sleep Monitoring</arm_group_label>
    <other_name>Personal Sleep Monitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 years or older&#xD;
&#xD;
          -  Self-report difficulty sleeping&#xD;
&#xD;
          -  Willingness to wear the PSMD for four weeks&#xD;
&#xD;
          -  Cognitive abilities (Mini Cog of 5 or above).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 65&#xD;
&#xD;
          -  Presence of known sleep disorders&#xD;
&#xD;
          -  Severe cognitive or neurosensory impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raeann G LeBlanc, PhD, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Amherst</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts</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>February 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Amherst</investigator_affiliation>
    <investigator_full_name>Raeann G LeBlanc</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Older People</keyword>
  <keyword>Sleep Disturbance</keyword>
  <keyword>Self-Monitoring</keyword>
  <keyword>Self-Management</keyword>
  <keyword>Social Support</keyword>
  <keyword>Wrist-worn Actigraphy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD data will be shared de-identified as a GUID with the cdRNS data base.</ipd_description>
  </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/NCT03837249
org study id: 2018-5225
nct id: NCT03837249
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the feasibility of older persons use of a personal sleep
      monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to
      50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively
      influences subjective and objective health outcomes.To improve their sleep, older adults with
      chronic health conditions could benefit from objective information, available through
      personal health monitoring devices, about their current and changing sleep patterns. Based on
      this information, sleep self-management interventions can be individualized and shared, and
      associations between sleep and health changes may be better managed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparative control - 3 group
primary purpose: Health Services Research
masking: Single (Participant)
masking description: One group - personal sleep monitoring data with-held then provided after the intervention period.
measure: Use of A Personal Sleep Monitoring Device (PSMD)
time frame: up to 4 weeks
description: Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
measure: Changes in Sleep
time frame: Week 1 and Week 4
description: Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.
measure: Changes in Health
time frame: Week 1 and Week 4
description: Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)
measure: Usability of PSMD
time frame: Week 2 and 4
description: Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device
arm group label: Passive Personal Sleep Monitoring
arm group type: Placebo Comparator
description: Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).
arm group label: Individual Personal Sleep Monitoring
arm group type: Active Comparator
description: Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.
arm group label: Socially Supported Sleep Monitoring
arm group type: Active Comparator
description: Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.
intervention type: Device
intervention name: Personal Sleep Monitoring
description: Wearable Sleep Self-Monitoring Device (Actigraphy)
arm group label: Individual Personal Sleep Monitoring
arm group label: Passive Personal Sleep Monitoring
arm group label: Socially Supported Sleep Monitoring
other name: Personal Sleep Monitor
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raeann G LeBlanc, PhD, DNP
role: Principal Investigator
affiliation: University of Massachusetts, Amherst
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Amherst
investigator full name: Raeann G LeBlanc
investigator title: Assistant Clinical Professor
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: No
ipd description: IPD data will be shared de-identified as a GUID with the cdRNS data base.