<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/NCT02236676</url>
  </required_header>
  <id_info>
    <org_study_id>R-833-14</org_study_id>
    <nct_id>NCT02236676</nct_id>
  </id_info>
  <brief_title>Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital</brief_title>
  <official_title>Sleep, Procedural Learning &amp; Therapeutic Engagement Among Inpatients With</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New Jersey Commission on Brain Injury Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kessler Foundation</source>
  <brief_summary>
    <textblock>
      The purpose of this research study is to better understand how a daytime nap after training&#xD;
      on a motor skill after brain injury improves performance compared with the same amount of&#xD;
      time after training spent awake and resting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2014</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement on Motor Functioning Test</measure>
    <time_frame>Three Nights and Three Days</time_frame>
    <description>Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Motor Learning in TBI</condition>
  <arm_group>
    <arm_group_label>Nap after rehearsal trials</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 30-minute daytime nap after training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting while awake</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nap after rehearsal trials</intervention_name>
    <description>Behavioral</description>
    <arm_group_label>Nap after rehearsal trials</arm_group_label>
    <arm_group_label>Resting while awake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a Traumatic Brain Injury.&#xD;
&#xD;
          -  Must have been a Kessler Institute for Rehabilitation inpatient for at least three&#xD;
             days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of&#xD;
             the WatchPAT-200/actigragh.&#xD;
&#xD;
          -  Movement disorder or spasticity affecting both upper extremities&#xD;
&#xD;
          -  Patients who are ventilator-dependent.&#xD;
&#xD;
          -  Patients who are on contact precautions for C.diff or other highly contagious&#xD;
             diseases.&#xD;
&#xD;
          -  Patients with neurological disorders other than TBI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kessler Foundation</investigator_affiliation>
    <investigator_full_name>Anthony Lequerica</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <keyword>motor learning TBI</keyword>
  <!-- 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/NCT02236676
org study id: R-833-14
nct id: NCT02236676
lead sponsor: 
collaborator: 
The purpose of this research study is to better understand how a daytime nap after training
      on a motor skill after brain injury improves performance compared with the same amount of
      time after training spent awake and resting.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement on Motor Functioning Test
time frame: Three Nights and Three Days
description: Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions
arm group label: Nap after rehearsal trials
arm group type: Active Comparator
description: A 30-minute daytime nap after training
arm group label: Resting while awake
arm group type: Placebo Comparator
description: Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed.
intervention type: Behavioral
intervention name: Nap after rehearsal trials
description: Behavioral
arm group label: Nap after rehearsal trials
arm group label: Resting while awake
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kessler Foundation
investigator full name: Anthony Lequerica
investigator title: Senior Research Scientist