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/NCT05968820</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00150428</org_study_id>
      <nct_id>NCT05968820</nct_id>
    </id_info>
    <brief_title>Sleep Health Enhancement in Older Adults to Address Frailty</brief_title>
    <official_title>Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kansas Medical Center</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 objective of the proposed study is to tailor a sleep health enhancement intervention to&#xD;
        older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot&#xD;
        study will be conducted in two stages. In the treatment development stage, we will recruit&#xD;
        n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report&#xD;
        questionnaire) to assess acceptability and tailor the sleep health enhancement intervention&#xD;
        for older adults. In the pilot study stage to assess preliminary efficacy of the tailored&#xD;
        sleep health enhancement intervention, n=30 older adults with poor sleep health will be&#xD;
        randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement&#xD;
        intervention or to a wait-list control condition. Participants will wear wrist-worn&#xD;
        actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and&#xD;
        reassessments.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6-item Acceptability Scale</measure>
      <time_frame>6 week</time_frame>
      <description>5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>semi-standardized qualitative interview</measure>
      <time_frame>6 week</time_frame>
      <description>Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tilburg Frailty Indicator</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHOQOL-BREF</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ru_SATED sleep health composite</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of &gt;5 indicates poor sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Epworth Sleepiness Scale</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dysfunctional Beliefs About Sleep</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Self-Efficacy</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Actigraphy</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Participants will wear an actigraph on their non-dominant wrist for 7 nights</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Timed Up and Go</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Timed Up and Go measures functional mobility and consists of sitting in a chair, standing up, walking 3-m, turning around, returning to the chair, and sitting down. The outcome is the time in seconds it takes to complete the task.</description>
    </other_outcome>
    <other_outcome>
      <measure>15 ft walk test</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The test is performed in a hallway or open space, and the time it takes to walk 15 ft is noted in seconds.</description>
    </other_outcome>
    <other_outcome>
      <measure>6-Minute Walk Test (6MWT)</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The test is performed in a hallway or open space with two cones marking the turn-around points. The participant walks between the two cones for six minutes. Distance is measured by number of laps completed.</description>
    </other_outcome>
    <other_outcome>
      <measure>Grip strength of the dominant and nondominant hand</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Grip strength of the dominant and nondominant hand will be assessed using a dynamometer with the participant seated, elbow flexed to 90 degrees, and arm by their side. The participant will perform one practice submaximal effort for acclimation followed by one maximal effort squeeze.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Continuous Performance Test (CPT)</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The Continuous Performance Test (CPT) requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except &quot;X.&quot; The participants' scores will be determined by their scores in detectability (e.g., difficulty differentiating targets from non-targets), error type (e.g., omissions, commissions, perseverations) and reaction time statistics.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Stroop Test</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>The Stroop Test requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color). Each participant is given a list of X's printed in colored ink and a list of words printed in colored ink. The participant is instructed to name the color of the ink. They are given 45 seconds to name as many colors as they can. The reported outcome measure of this test is an interference score that is the difference between the two conditions while normalizing for number of x's using the following formulae: x-words/x.</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive Failures Questionnaire (CFQ)</measure>
      <time_frame>baseline, 6 week and 12 week reassessments</time_frame>
      <description>Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = &quot;never&quot; and 4 = &quot;Very Often&quot; with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Sleep Health Enhancement Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-List Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sleep Health Enhancement Intervention</intervention_name>
      <description>The program is based on principles from CBT-I (time in bed restriction, stimulus control, relaxation techniques, sleep education) and includes behavioral strategies to entrain circadian rhythm, strengthen sleep homeostasis, reduce hyperarousal, and sleep hygiene techniques. Self-Determination Theory (SDT) and Social Cognitive Theory (SCT) will serve as the theoretic framework for behavior change techniques (BCT) threaded through the sleep health enhancement intervention. Participants will maintain a sleep diary during the program to aid in tailoring the program, self-monitoring of behavior, and feedback of behavior. Goals will be set by the participant at each session and reviewed at subsequent sessions, and motivational interviewing principles will be incorporated.</description>
      <arm_group_label>Sleep Health Enhancement Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. ≥65 years old, 2. ≤ 7 on the RU-SATED self-report questionnaire, and 3. MMSE ≥25 and AD8&#xD;
          &lt;3.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Known untreated sleep disorder (such as sleep apnea or restless leg syndrome); 2. &gt;3 on&#xD;
          the STOP BANG indicating increased risk of sleep apnea; 3. Increased risk of restless legs&#xD;
          syndrome on RLS-Diagnosis Index; 4. Evidence of circadian rhythm sleep-wake disorder; 5.&#xD;
          Evidence of parasomnia; 6. Regular use (&gt;2x/week) of prescription or over-the-counter&#xD;
          medications to improve sleep; 7. Score of ≥15 on the Patient Health Questionnaire (PHQ-9)&#xD;
          indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on&#xD;
          #9 of the PHQ-9); 8. Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating&#xD;
          moderate to severe anxiety; 9. Self-report of current or history (up to 2 years) of drug or&#xD;
          alcohol abuse based on the DSM-5-TR criteria; 10. History of nervous system disorder such&#xD;
          as stroke or Parkinson's disease; 11. Severe mental illness such as schizophrenia or&#xD;
          bipolar disorder; 12. Current or history (within 5 years) of shift work including hours of&#xD;
          midnight-4am; and 13. Is currently receiving a behavioral sleep health intervention.&#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_contact>
      <last_name>Catherine Siengsukon, PhD</last_name>
      <phone>913-588-6913</phone>
      <email>csiengsukon@kumc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eryen Nelson, MPH</last_name>
      <phone>913-945-7349</phone>
      <email>enelson5@kumc.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
      <investigator_full_name>Catherine Siengsukon, PT, PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Sleep Health, Older Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</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/NCT05968820
  org study id: STUDY00150428
  nct id: NCT05968820
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the proposed study is to tailor a sleep health enhancement intervention to
        older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot
        study will be conducted in two stages. In the treatment development stage, we will recruit
        n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report
        questionnaire) to assess acceptability and tailor the sleep health enhancement intervention
        for older adults. In the pilot study stage to assess preliminary efficacy of the tailored
        sleep health enhancement intervention, n=30 older adults with poor sleep health will be
        randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement
        intervention or to a wait-list control condition. Participants will wear wrist-worn
        actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and
        reassessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: 6-item Acceptability Scale
  time frame: 6 week
  description: 5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
  measure: semi-standardized qualitative interview
  time frame: 6 week
  description: Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes
  measure: Tilburg Frailty Indicator
  time frame: baseline, 6 week and 12 week reassessments
  description: The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.
  measure: WHOQOL-BREF
  time frame: baseline, 6 week and 12 week reassessments
  description: The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.
  measure: Ru_SATED sleep health composite
  time frame: baseline, 6 week and 12 week reassessments
  description: Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires
  measure: Pittsburgh Sleep Quality Index
  time frame: baseline, 6 week and 12 week reassessments
  description: Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of >5 indicates poor sleep quality.
  measure: Epworth Sleepiness Scale
  time frame: baseline, 6 week and 12 week reassessments
  description: Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze.
  measure: Dysfunctional Beliefs About Sleep
  time frame: baseline, 6 week and 12 week reassessments
  description: This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
  measure: Sleep Self-Efficacy
  time frame: baseline, 6 week and 12 week reassessments
  description: Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
  measure: Actigraphy
  time frame: baseline, 6 week and 12 week reassessments
  description: Participants will wear an actigraph on their non-dominant wrist for 7 nights
  measure: Timed Up and Go
  time frame: baseline, 6 week and 12 week reassessments
  description: Timed Up and Go measures functional mobility and consists of sitting in a chair, standing up, walking 3-m, turning around, returning to the chair, and sitting down. The outcome is the time in seconds it takes to complete the task.
  measure: 15 ft walk test
  time frame: baseline, 6 week and 12 week reassessments
  description: The test is performed in a hallway or open space, and the time it takes to walk 15 ft is noted in seconds.
  measure: 6-Minute Walk Test (6MWT)
  time frame: baseline, 6 week and 12 week reassessments
  description: The test is performed in a hallway or open space with two cones marking the turn-around points. The participant walks between the two cones for six minutes. Distance is measured by number of laps completed.
  measure: Grip strength of the dominant and nondominant hand
  time frame: baseline, 6 week and 12 week reassessments
  description: Grip strength of the dominant and nondominant hand will be assessed using a dynamometer with the participant seated, elbow flexed to 90 degrees, and arm by their side. The participant will perform one practice submaximal effort for acclimation followed by one maximal effort squeeze.
  measure: The Continuous Performance Test (CPT)
  time frame: baseline, 6 week and 12 week reassessments
  description: The Continuous Performance Test (CPT) requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except "X." The participants' scores will be determined by their scores in detectability (e.g., difficulty differentiating targets from non-targets), error type (e.g., omissions, commissions, perseverations) and reaction time statistics.
  measure: The Stroop Test
  time frame: baseline, 6 week and 12 week reassessments
  description: The Stroop Test requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color). Each participant is given a list of X's printed in colored ink and a list of words printed in colored ink. The participant is instructed to name the color of the ink. They are given 45 seconds to name as many colors as they can. The reported outcome measure of this test is an interference score that is the difference between the two conditions while normalizing for number of x's using the following formulae: x-words/x.
  measure: Cognitive Failures Questionnaire (CFQ)
  time frame: baseline, 6 week and 12 week reassessments
  description: Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
  arm group label: Sleep Health Enhancement Intervention
  arm group type: Experimental
  description: The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention.
  arm group label: Wait-List Control Group
  arm group type: No Intervention
  description: The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment.
  intervention type: Behavioral
  intervention name: Sleep Health Enhancement Intervention
  description: The program is based on principles from CBT-I (time in bed restriction, stimulus control, relaxation techniques, sleep education) and includes behavioral strategies to entrain circadian rhythm, strengthen sleep homeostasis, reduce hyperarousal, and sleep hygiene techniques. Self-Determination Theory (SDT) and Social Cognitive Theory (SCT) will serve as the theoretic framework for behavior change techniques (BCT) threaded through the sleep health enhancement intervention. Participants will maintain a sleep diary during the program to aid in tailoring the program, self-monitoring of behavior, and feedback of behavior. Goals will be set by the participant at each session and reviewed at subsequent sessions, and motivational interviewing principles will be incorporated.
  arm group label: Sleep Health Enhancement Intervention
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Catherine Siengsukon, PhD
  phone: 913-588-6913
  email: csiengsukon@kumc.edu
  last name: Eryen Nelson, MPH
  phone: 913-945-7349
  email: enelson5@kumc.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Kansas Medical Center
  investigator full name: Catherine Siengsukon, PT, PhD
  investigator title: Professor
  mesh term: Frailty
  sharing ipd: No