<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/NCT04400617</url>
  </required_header>
  <id_info>
    <org_study_id>REB 19-1939</org_study_id>
    <nct_id>NCT04400617</nct_id>
  </id_info>
  <brief_title>Sleep Quality in Assisted-Living Residents</brief_title>
  <official_title>Understanding the Association Between Sleep Quality, Physical Activity, and Memory in Assisted-Living Residents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Brenda Strafford Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</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>
      Assisted living residents who have sleep disturbances are at great risk of developing&#xD;
      cognitive impairments. The identification of factors that increase sleep problems in this&#xD;
      population is the first step towards improving sleep disorders and reducing and/or delaying&#xD;
      the occurrence of cognitive impairments in this population. Physical activity has been&#xD;
      proposed to improve sleep quality in older individuals, but there is currently no scientific&#xD;
      evidence of how sleep mediates the relationship between physical activity and cognition in&#xD;
      assisted living residents. This is a cross-sectional study that investigates the relationship&#xD;
      between sleep quality, functional/physical capacity, and cognitive performance. Participants&#xD;
      will be recruited through a non-probabilistic sampling method (convenience) as this is a&#xD;
      feasibility study that aims to identify, for the first time, sleep disorders in assisted&#xD;
      living residents using objective measures of sleep. Sleep quality will be measured with&#xD;
      polysomnography, actigraphy, and questionnaire. Functional and physical capacity will be&#xD;
      assessed through walking tasks and actigraphy. Cognitive tasks will be used to assess memory.&#xD;
      This study will bring new insights into the factors that affect the quality of life and sleep&#xD;
      in assisted living residents. The evidence-based knowledge acquired on-site will be&#xD;
      translated and shared with the local and global scientific community to raise awareness of&#xD;
      the factors that contribute to increasing institutionalization and dependent living. Results&#xD;
      obtained from objective and subjective measures of sleep will be of great importance to&#xD;
      develop specialized clinical expertise and behavioral interventions that will meet residents'&#xD;
      needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Objectives and Hypotheses:&#xD;
&#xD;
        1. To test the feasibility of using polysomnography to identify the severity of sleep&#xD;
           disorders in assisted living residents.&#xD;
&#xD;
           The implementation of objective measures of sleep in assisted living residents is&#xD;
           practical and provides accurate information on sleep architecture parameters.&#xD;
&#xD;
        2. To investigate the association between functional capacity and physical activity and&#xD;
           sleep quality in assisted living residents using functional tests and actigraphy,&#xD;
           respectively.&#xD;
&#xD;
           There is a positive association between functional capacity and sleep quality and&#xD;
           physical activity will improve sleep quality in the efficiency and duration domains.&#xD;
&#xD;
        3. To investigate the association between sleep quality, measured through actigraphy, and&#xD;
           cognitive performance, specifically in the memory domain, in assisted living residents.&#xD;
&#xD;
           There is a positive association between sleep quality, especially sleep efficiency, and&#xD;
           cognitive performance.&#xD;
&#xD;
        4. To compare the sleep quality (measured with polysomnography, actigraphy, and&#xD;
           questionnaire) in assisted living residents with older individuals of the same age and&#xD;
           cognitive performance (Montreal Cognitive Assessment; MoCA score &gt; 26) who live&#xD;
           independently.&#xD;
&#xD;
      Sleep quality will be lower in assisted living residents in comparison with older individuals&#xD;
      who live independently and the use of various methods to assess sleep quality will provide a&#xD;
      better estimation of the differences in sleep quality between these populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2023</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total sleep time.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep efficiency.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep onset latency.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of awakening.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PSQI component score.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) will be used to subjectively measure sleep quality and disturbances in the past few months. The self-related questions include the assessment of seven different sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The participant should score each of the seven areas from 0 (no difficulty) to 3 (severe difficulty). Final score ≥ 5 indicates poor sleep quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short-term memory, visuospatial ability, and executive function.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Montreal Cognitive Assessment (MoCA) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visuo-spatial memory.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Visuospatial Memory Test-Revised (BVMT-R) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal learning and memory.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Hopkins Verbal Learning Test-Revised (HVLT-R) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Time up and Go (TUG) task will be performed. The TUG test considers the time the participant takes to stand up from a chair, walk 3 m away, return to the chair, and sit down in the chair again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-task capacity.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Cognitive TUG (TUGcog) will be performed. In the TUGcog test, the participant should perform the same task while counting backward from a randomly assigned number between 60 and 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of counts (physical activity).</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The Actiwatch 2 will be used for 14 days to record total movement and patterns of activity per day.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Assisted-living residents</arm_group_label>
    <description>The target population will be inactive men and women residents of the Brenda Strafford Foundation (&gt; 50 yrs. old). We expect the participants to be classified as inactivity, which will be defined as an engagement in &lt; 3 sessions/week of 20 min or more of vigorous exercise. Participants should be able to move independently without the assistance of a wheelchair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Volunteers from the Brain in Motion II (BIM II) study (NCT03035851). The BIM II study aims to examine the mechanisms whereby exercise may improve sleep and cognition in men and women aged 50 to 80 years old. As the baseline measurements of the BIM II study are similar to the assessments proposed in this study, the assisted living residents will be matched with older individuals of the same age and cognitive performance who live independently to answer the last research question.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.</intervention_name>
    <description>The first visit will consist of screening measurements. Participants will be asked to complete the following questionnaires: InterRAI Self Report Quality of Life Survey for Long Term Care Facilities (interRAI SQoL), Resident Assessment Instrument (RAI)-MDS 2.0, Global Physical Activity Questionnaire (GPAQ), Memory Complaint Questionnaire (MAC-Q), and Pittsburgh Sleep Quality Index (PSQI). At the end of this visit, the participants will be asked to wear the ActiWatch-2 (AW-2) as a wristwatch for 14 days. In the second visit, participants' height and weight will be measured and the participants will perform the following cognitive and functional tests: MoCA, Brief Visuospatial Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test-Revised (HVLT-R), Time up and Go (TUG), and Cognitive TUG (TUGcog). Finally, visit 3 will consist of on-site PSG recordings.</description>
    <arm_group_label>Assisted-living residents</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population will be inactive men and women residents of the Brenda Strafford&#xD;
        Foundation (&gt; 50 yrs. old).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be inactivity, which will be defined as an engagement in &lt; 3 sessions/week of 20 min&#xD;
             or more of vigorous exercise;&#xD;
&#xD;
          -  Be able to move independently without the assistance of a wheelchair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a developmental handicap;&#xD;
&#xD;
          -  Residents who are not able to understand communication and be understood by others and&#xD;
             do not have decision-making capacity according to the Cognitive Performance Scale&#xD;
             (CPS) &gt; 3; The investigators will assess all the resident's capacity with the Brenda&#xD;
             Strafford Foundation caregivers, even if their CPS is within the range included in the&#xD;
             study (CPS 0-3);&#xD;
&#xD;
          -  Terminal illness (life expectancy &lt; 1 year);&#xD;
&#xD;
          -  Not fluent in English;&#xD;
&#xD;
          -  Currently participating in another trial;&#xD;
&#xD;
          -  Comorbid medical or neurological illnesses (e.g., multiple sclerosis) that would&#xD;
             confound cognitive assessments or make trial completion unlikely (in the site&#xD;
             investigator's opinion);&#xD;
&#xD;
          -  Contraindication for the tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Marc J Poulin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc J Poulin, PhD</last_name>
    <phone>403.220.8372</phone>
    <email>poulin@ucalgary.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Renata L Kruger, PhD</last_name>
    <phone>403.210.6506</phone>
    <email>renata.kruger@ucalgary.ca</email>
  </overall_contact_backup>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Marc Poulin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Sleep</keyword>
  <keyword>Functional Capacity</keyword>
  <keyword>Cognitive Performance</keyword>
  <keyword>Assisted-Living Facilities</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>
  </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/NCT04400617
org study id: REB 19-1939
nct id: NCT04400617
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assisted living residents who have sleep disturbances are at great risk of developing
      cognitive impairments. The identification of factors that increase sleep problems in this
      population is the first step towards improving sleep disorders and reducing and/or delaying
      the occurrence of cognitive impairments in this population. Physical activity has been
      proposed to improve sleep quality in older individuals, but there is currently no scientific
      evidence of how sleep mediates the relationship between physical activity and cognition in
      assisted living residents. This is a cross-sectional study that investigates the relationship
      between sleep quality, functional/physical capacity, and cognitive performance. Participants
      will be recruited through a non-probabilistic sampling method (convenience) as this is a
      feasibility study that aims to identify, for the first time, sleep disorders in assisted
      living residents using objective measures of sleep. Sleep quality will be measured with
      polysomnography, actigraphy, and questionnaire. Functional and physical capacity will be
      assessed through walking tasks and actigraphy. Cognitive tasks will be used to assess memory.
      This study will bring new insights into the factors that affect the quality of life and sleep
      in assisted living residents. The evidence-based knowledge acquired on-site will be
      translated and shared with the local and global scientific community to raise awareness of
      the factors that contribute to increasing institutionalization and dependent living. Results
      obtained from objective and subjective measures of sleep will be of great importance to
      develop specialized clinical expertise and behavioral interventions that will meet residents'
      needs.
Specific Objectives and Hypotheses:

        1. To test the feasibility of using polysomnography to identify the severity of sleep
           disorders in assisted living residents.

           The implementation of objective measures of sleep in assisted living residents is
           practical and provides accurate information on sleep architecture parameters.

        2. To investigate the association between functional capacity and physical activity and
           sleep quality in assisted living residents using functional tests and actigraphy,
           respectively.

           There is a positive association between functional capacity and sleep quality and
           physical activity will improve sleep quality in the efficiency and duration domains.

        3. To investigate the association between sleep quality, measured through actigraphy, and
           cognitive performance, specifically in the memory domain, in assisted living residents.

           There is a positive association between sleep quality, especially sleep efficiency, and
           cognitive performance.

        4. To compare the sleep quality (measured with polysomnography, actigraphy, and
           questionnaire) in assisted living residents with older individuals of the same age and
           cognitive performance (Montreal Cognitive Assessment; MoCA score > 26) who live
           independently.

      Sleep quality will be lower in assisted living residents in comparison with older individuals
      who live independently and the use of various methods to assess sleep quality will provide a
      better estimation of the differences in sleep quality between these populations.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Total sleep time.
time frame: Through study completion, an average of 1 year.
description: The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
measure: Sleep efficiency.
time frame: Through study completion, an average of 1 year.
description: The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
measure: Sleep onset latency.
time frame: Through study completion, an average of 1 year.
description: The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
measure: Number of awakening.
time frame: Through study completion, an average of 1 year.
description: The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
measure: PSQI component score.
time frame: Through study completion, an average of 1 year.
description: The Pittsburgh Sleep Quality Index (PSQI) will be used to subjectively measure sleep quality and disturbances in the past few months. The self-related questions include the assessment of seven different sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The participant should score each of the seven areas from 0 (no difficulty) to 3 (severe difficulty). Final score ≥ 5 indicates poor sleep quality.
measure: Short-term memory, visuospatial ability, and executive function.
time frame: Through study completion, an average of 1 year.
description: Montreal Cognitive Assessment (MoCA) will be used.
measure: Visuo-spatial memory.
time frame: Through study completion, an average of 1 year.
description: Visuospatial Memory Test-Revised (BVMT-R) will be used.
measure: Verbal learning and memory.
time frame: Through study completion, an average of 1 year.
description: Hopkins Verbal Learning Test-Revised (HVLT-R) will be used.
measure: Functional capacity.
time frame: Through study completion, an average of 1 year.
description: Time up and Go (TUG) task will be performed. The TUG test considers the time the participant takes to stand up from a chair, walk 3 m away, return to the chair, and sit down in the chair again.
measure: Dual-task capacity.
time frame: Through study completion, an average of 1 year.
description: Cognitive TUG (TUGcog) will be performed. In the TUGcog test, the participant should perform the same task while counting backward from a randomly assigned number between 60 and 100
measure: Total number of counts (physical activity).
time frame: Through study completion, an average of 1 year.
description: The Actiwatch 2 will be used for 14 days to record total movement and patterns of activity per day.
arm group label: Assisted-living residents
description: The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old). We expect the participants to be classified as inactivity, which will be defined as an engagement in < 3 sessions/week of 20 min or more of vigorous exercise. Participants should be able to move independently without the assistance of a wheelchair.
arm group label: Control group
description: Volunteers from the Brain in Motion II (BIM II) study (NCT03035851). The BIM II study aims to examine the mechanisms whereby exercise may improve sleep and cognition in men and women aged 50 to 80 years old. As the baseline measurements of the BIM II study are similar to the assessments proposed in this study, the assisted living residents will be matched with older individuals of the same age and cognitive performance who live independently to answer the last research question.
intervention type: Behavioral
intervention name: Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.
description: The first visit will consist of screening measurements. Participants will be asked to complete the following questionnaires: InterRAI Self Report Quality of Life Survey for Long Term Care Facilities (interRAI SQoL), Resident Assessment Instrument (RAI)-MDS 2.0, Global Physical Activity Questionnaire (GPAQ), Memory Complaint Questionnaire (MAC-Q), and Pittsburgh Sleep Quality Index (PSQI). At the end of this visit, the participants will be asked to wear the ActiWatch-2 (AW-2) as a wristwatch for 14 days. In the second visit, participants' height and weight will be measured and the participants will perform the following cognitive and functional tests: MoCA, Brief Visuospatial Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test-Revised (HVLT-R), Time up and Go (TUG), and Cognitive TUG (TUGcog). Finally, visit 3 will consist of on-site PSG recordings.
arm group label: Assisted-living residents
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
last name: Marc J Poulin, PhD
role: Principal Investigator
affiliation: University of Calgary
last name: Marc J Poulin, PhD
phone: 403.220.8372
email: poulin@ucalgary.ca
last name: Renata L Kruger, PhD
phone: 403.210.6506
email: renata.kruger@ucalgary.ca
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Marc Poulin
investigator title: Professor
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: No