<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/NCT02967185</url>
  </required_header>
  <id_info>
    <org_study_id>221286</org_study_id>
    <nct_id>NCT02967185</nct_id>
  </id_info>
  <brief_title>Intraindividual Variability in Sleep and Cognitive Performance in Older Adults</brief_title>
  <acronym>REST</acronym>
  <official_title>Intraindividual Variability in Sleep and Cognitive Performance in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will examine changes in older insomniacs' cognitive functioning following&#xD;
      behavioral treatment for insomnia using a combination of two methods. A traditional repeated&#xD;
      measures design will be used to look at group level differences based on performance on a&#xD;
      neuropsychological battery administered prior to, immediately after, and 3 months after&#xD;
      completing a 4 week behavioral treatment program for insomnia. This data will be analyzed&#xD;
      using standard repeated measures analytic techniques. A time-series design will also be used&#xD;
      to look at within-subject differences based on a brief cognitive battery that will be&#xD;
      self-administered on a daily basis. Data from this daily battery will be examined using&#xD;
      intraindividual variability modeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <completion_date type="Actual">April 2008</completion_date>
  <primary_completion_date type="Actual">April 2008</primary_completion_date>
  <phase>Phase 2</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>Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Participants will complete a daily sleep dairies throughout the study period. They will report their bedtime, waketime, sleep onset latency, and wake time after sleep onset. Total sleep time and total wake time will be calculated from the diaries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in actigraphy-assessed sleep variability from baseline to follow-up</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Participants wore an Actiwatch-L (ACTL) (Mini Mitter Co., Inc.) on their non-dominant wrists continuously throughout the study. The sensor of the ACTL is sampled 32 times per second and records peak values for each second. These peak values are then summed into 30-second &quot;activity&quot; counts. These activity counts are downloaded to a personal computer and analyzed using Actiware-Sleep v. 3.3, which uses a validated algorithm to identify periods of as sleep or wake. Total sleep time and total wake time will be computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Mini-Mental Status Exam</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Mini-Mental Status Exam (MMSE) (Folstein, Folstein, &amp; McHugh, 1975)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary &amp; Digit Symbol</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Wechsler Adult Intelligence Scale-3, Vocabulary &amp; Digit Symbol (subtests) [WAIS-3]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Trails A &amp; B (Reitan, 1958)</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Trails A &amp; B (Reitan, 1958) was administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Controlled Oral Word Association</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Controlled Oral Word Association (COWA) (Benton &amp; Hamsher, 1983)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Boston Naming Test (BNT)</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>Boston Naming Test (BNT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
    <description>California Verbal Learning Test (CVLT, CVLT-II) (Delis, Kramer, Kaplan, &amp; Ober, 1987)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley &amp; Tremblay, 2002)</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the Wechsler Memory Scale-3, Logical Memory &amp; Visual Reproduction subtests (WMS-3) Tremblay, 2002)</measure>
    <time_frame>from baseline to follow-up, approximately 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Insomnia Chronic</condition>
  <arm_group>
    <arm_group_label>Brief Behavioral Therapy for Insomnia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive no intervention, but will complete the same set of assessments as those in the Experimental Group. They will be given the option of receiving the behavioral treatment program at no charge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Behavioral Therapy for Insomnia</intervention_name>
    <description>Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.</description>
    <arm_group_label>Brief Behavioral Therapy for Insomnia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;65 years&#xD;
&#xD;
          -  Community dwelling&#xD;
&#xD;
          -  Available for duration of study&#xD;
&#xD;
          -  Insomnia according to American Sleep Disorders Association (1990) criteria: (a) &gt;30&#xD;
             minutes of unwanted awake time, 3 nights per week for at least 6 months and (b)&#xD;
             Daytime dysfunction (reported mood, cognitive, social, or occupational impairment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 65&#xD;
&#xD;
          -  history of primary sleep disorder (e.g., sleep apnea, narcolepsy)&#xD;
&#xD;
          -  history of stroke&#xD;
&#xD;
          -  major medical illness known to contribute to sleep problems in last 12 months&#xD;
&#xD;
          -  cognitive impairment that interferes with ability to understand treatment (score &lt;23&#xD;
             on Mini-Mental State Examination)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina McCrae, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <results_reference>
    <citation>McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.</citation>
    <PMID>17974868</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Christina McCrae</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT02967185
org study id: 221286
nct id: NCT02967185
lead sponsor: 
collaborator: 
has dmc: No
The proposed study will examine changes in older insomniacs' cognitive functioning following
      behavioral treatment for insomnia using a combination of two methods. A traditional repeated
      measures design will be used to look at group level differences based on performance on a
      neuropsychological battery administered prior to, immediately after, and 3 months after
      completing a 4 week behavioral treatment program for insomnia. This data will be analyzed
      using standard repeated measures analytic techniques. A time-series design will also be used
      to look at within-subject differences based on a brief cognitive battery that will be
      self-administered on a daily basis. Data from this daily battery will be examined using
      intraindividual variability modeling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up
time frame: from baseline to follow-up, approximately 1 year
description: Participants will complete a daily sleep dairies throughout the study period. They will report their bedtime, waketime, sleep onset latency, and wake time after sleep onset. Total sleep time and total wake time will be calculated from the diaries.
measure: Change in actigraphy-assessed sleep variability from baseline to follow-up
time frame: from baseline to follow-up, approximately 1 year
description: Participants wore an Actiwatch-L (ACTL) (Mini Mitter Co., Inc.) on their non-dominant wrists continuously throughout the study. The sensor of the ACTL is sampled 32 times per second and records peak values for each second. These peak values are then summed into 30-second "activity" counts. These activity counts are downloaded to a personal computer and analyzed using Actiware-Sleep v. 3.3, which uses a validated algorithm to identify periods of as sleep or wake. Total sleep time and total wake time will be computed.
measure: Change in performance on the Mini-Mental Status Exam
time frame: from baseline to follow-up, approximately 1 year
description: Mini-Mental Status Exam (MMSE) (Folstein, Folstein, & McHugh, 1975)
measure: Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol
time frame: from baseline to follow-up, approximately 1 year
description: Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol (subtests) [WAIS-3]
measure: Change in performance on the Trails A & B (Reitan, 1958)
time frame: from baseline to follow-up, approximately 1 year
description: Trails A & B (Reitan, 1958) was administered
measure: Change in performance on the Controlled Oral Word Association
time frame: from baseline to follow-up, approximately 1 year
description: Controlled Oral Word Association (COWA) (Benton & Hamsher, 1983)
measure: Change in performance on the Boston Naming Test (BNT)
time frame: from baseline to follow-up, approximately 1 year
description: Boston Naming Test (BNT)
measure: Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)
time frame: from baseline to follow-up, approximately 1 year
description: California Verbal Learning Test (CVLT, CVLT-II) (Delis, Kramer, Kaplan, & Ober, 1987)
measure: Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002)
time frame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002)
time frame: from baseline to follow-up, approximately 1 year
arm group label: Brief Behavioral Therapy for Insomnia
arm group type: Experimental
description: Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis.
arm group label: Waitlist Control
arm group type: No Intervention
description: Participants in this group will receive no intervention, but will complete the same set of assessments as those in the Experimental Group. They will be given the option of receiving the behavioral treatment program at no charge.
intervention type: Behavioral
intervention name: Brief Behavioral Therapy for Insomnia
description: Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.
arm group label: Brief Behavioral Therapy for Insomnia
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Christina McCrae, PhD
role: Principal Investigator
affiliation: University of Missouri-Columbia
citation: McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.
PMID: 17974868
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Christina McCrae
investigator title: Professor
sharing ipd: No