<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/NCT03781076</url>
  </required_header>
  <id_info>
    <org_study_id>IRB number 2018-5952</org_study_id>
    <nct_id>NCT03781076</nct_id>
  </id_info>
  <brief_title>Sleep After Adolescent Concussion</brief_title>
  <official_title>Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cincinnati Children's Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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 research study is to learn more about how sleep changes as teens recover&#xD;
      from concussions. We also want to learn if we can improve sleep in teens who have&#xD;
      concussions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mild traumatic brain injuries (mTBI), also called concussions, affect millions of individuals&#xD;
      and cost over $17 billion in the US annually. Despite the term &quot;mild,&quot; mTBI symptoms in&#xD;
      children and adolescents (e.g., poor concentration, headache, emotional lability, slow&#xD;
      thinking) seriously disrupt all aspects of a patient's functioning and impair quality of&#xD;
      life. Although many youth recover quickly from mTBI, 30-60% remain symptomatic a month later.&#xD;
      A biopsychosocial model was developed to account for protracted recoveries. In this model,&#xD;
      acute symptoms result from a rapid cascade of injury-related neurometabolic and&#xD;
      micro-structural aberrations. Since the vast majority of these abate within 1-3 weeks&#xD;
      post-injury, persistent symptoms become increasingly difficult to explain physiologically,&#xD;
      and psychosocial circumstances and patient behaviors become increasingly prominent&#xD;
      contributors to impairment. There is reason to believe that, after mTBI, sleep is an&#xD;
      underappreciated, modifiable behavior that drives impairment for youth with protracted&#xD;
      recoveries. Care recommendations often mention sleep, but the field lacks&#xD;
      empirically-supported guidelines and interventions for sleep after pediatric mTBI. Studies of&#xD;
      mTBI in youth have used crude, unvalidated sleep measures. Also, there is no systematic&#xD;
      research on non-injury contributors to poor sleep after mTBI, nor the nature and sources of&#xD;
      advice that families receive. Lacking such data, one cannot develop empirically-based sleep&#xD;
      recommendations. Finally, while there is reason to believe that a brief sleep intervention&#xD;
      can alleviate mTBI symptoms in many youth who are recovering slowly, this needs to be tested&#xD;
      in a well-powered clinical trial. The investigators are positioning to undertake such a&#xD;
      trial, but must first document feasibility and acceptability of a sleep intervention after&#xD;
      mTBI. To address these research gaps, the investigators are conducting a novel observational&#xD;
      study and pilot clinical trial with these Aims:&#xD;
&#xD;
      Aim 1: Establish more detailed and definitive links between protracted mTBI recovery and&#xD;
      sleep in 12-18-year-olds. The investigators are undertaking a prospective, observational&#xD;
      study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team&#xD;
      will also explore potential contributors to inadequate sleep, including sleep-related&#xD;
      behaviors and detail the nature and sources of information on sleep post mTBI.&#xD;
&#xD;
      Aim 2: Pilot-test a brief sleep intervention in the subset of youth who are slow to recover&#xD;
      from mTBI and show short sleep. The study team will document feasibility and acceptability,&#xD;
      and test its success in extending sleep duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Note that the intervention portion of the study involves only a subset of participants. The larger bulk (planned n=108) will undergo only initial observation of sleep and concussion symptoms. The investigators plan to have 24 (those still symptomatic at 4 weeks post-concussion who do not get recommended sleep) undergo a pilot trial of a sleep intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The intervention explicitly involves behavior change, so the participant cannot be blinded. The outcomes assessment involves objective monitors, and therefore can be considered blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Nocturnal sleep duration, quality, and regularity, as measured by wrist-mounted accelerometry (actigraphy). Although in theory there are upper limits on healthy sleep, in practice during adolescence better health is associated with longer nocturnal sleep, better sleep quality, and greater night-to-night consistency in sleep patterns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concussion Symptoms</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>A primary outcome for the observational phase of the study, and a secondary outcome for the intervention phase, will be the Post-Concussion Symptom Scale (PCSS). On the PCSS, 21 common symptoms after concussion are rated on a 0-6 scale; for this study the focus will be on the summed total across items. Higher scores indicate greater symptom severity.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Brain Concussion</condition>
  <arm_group>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this &quot;care as usual&quot; arm, no specific behavioral sleep intervention is provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Intervention</intervention_name>
    <description>The study therapist will outline the biopsychosocial model of mTBI recovery, highlighting the shift from biological injury to behavior (especially sleep behavior) as key driver of symptoms. The intervention will then apply well-established strategies from the pediatric psychology and insomnia literatures, encouraging conjoint problem-solving by parent and youth with the shared goal of maximizing nocturnal sleep. These include: pre-planning, problem-solving, development of a positive routine, commitment to sleep-promoting behaviors, self-monitoring, and positive reinforcement. The therapist will also teach a brief, self-guided pre-sleep relaxation exercise that has been used in insomnia treatment to maximize the benefit of additional sleep opportunity.</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12-18 years old&#xD;
&#xD;
          -  Had a mild TBI or concussion (blow to the head associated with loss of&#xD;
             consciousness&lt;30 min, amnesia, or alteration in mental status) &lt;3 weeks prior to study&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lowest Glasgow coma scale (GCS) &lt;13 or imaging evidence of intracranial abnormality&#xD;
             (i.e., too severe)&#xD;
&#xD;
          -  previous more severe TBI or mTBI within the prior 3 months (potential overlapping&#xD;
             recoveries)&#xD;
&#xD;
          -  extracranial injury with an Abbreviated Injury Severity Scale &gt;4 for that region&#xD;
             (non-mTBI injuries)&#xD;
&#xD;
          -  non-fluent in English&#xD;
&#xD;
          -  previously-diagnosed intellectual disability, autism, bipolar disorder, or psychosis&#xD;
             (could impact measure validity)&#xD;
&#xD;
          -  use of medication known to substantially affect sleep (e.g., stimulant).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dean W Beebe, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescence, Sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A deidentified data set may be available to qualified researchers who share specific research idea with the central contact person (Dr. Beebe, PI).</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/NCT03781076
org study id: IRB number 2018-5952
nct id: NCT03781076
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to learn more about how sleep changes as teens recover
      from concussions. We also want to learn if we can improve sleep in teens who have
      concussions.
Mild traumatic brain injuries (mTBI), also called concussions, affect millions of individuals
      and cost over $17 billion in the US annually. Despite the term "mild," mTBI symptoms in
      children and adolescents (e.g., poor concentration, headache, emotional lability, slow
      thinking) seriously disrupt all aspects of a patient's functioning and impair quality of
      life. Although many youth recover quickly from mTBI, 30-60% remain symptomatic a month later.
      A biopsychosocial model was developed to account for protracted recoveries. In this model,
      acute symptoms result from a rapid cascade of injury-related neurometabolic and
      micro-structural aberrations. Since the vast majority of these abate within 1-3 weeks
      post-injury, persistent symptoms become increasingly difficult to explain physiologically,
      and psychosocial circumstances and patient behaviors become increasingly prominent
      contributors to impairment. There is reason to believe that, after mTBI, sleep is an
      underappreciated, modifiable behavior that drives impairment for youth with protracted
      recoveries. Care recommendations often mention sleep, but the field lacks
      empirically-supported guidelines and interventions for sleep after pediatric mTBI. Studies of
      mTBI in youth have used crude, unvalidated sleep measures. Also, there is no systematic
      research on non-injury contributors to poor sleep after mTBI, nor the nature and sources of
      advice that families receive. Lacking such data, one cannot develop empirically-based sleep
      recommendations. Finally, while there is reason to believe that a brief sleep intervention
      can alleviate mTBI symptoms in many youth who are recovering slowly, this needs to be tested
      in a well-powered clinical trial. The investigators are positioning to undertake such a
      trial, but must first document feasibility and acceptability of a sleep intervention after
      mTBI. To address these research gaps, the investigators are conducting a novel observational
      study and pilot clinical trial with these Aims:

      Aim 1: Establish more detailed and definitive links between protracted mTBI recovery and
      sleep in 12-18-year-olds. The investigators are undertaking a prospective, observational
      study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team
      will also explore potential contributors to inadequate sleep, including sleep-related
      behaviors and detail the nature and sources of information on sleep post mTBI.

      Aim 2: Pilot-test a brief sleep intervention in the subset of youth who are slow to recover
      from mTBI and show short sleep. The study team will document feasibility and acceptability,
      and test its success in extending sleep duration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Note that the intervention portion of the study involves only a subset of participants. The larger bulk (planned n=108) will undergo only initial observation of sleep and concussion symptoms. The investigators plan to have 24 (those still symptomatic at 4 weeks post-concussion who do not get recommended sleep) undergo a pilot trial of a sleep intervention.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The intervention explicitly involves behavior change, so the participant cannot be blinded. The outcomes assessment involves objective monitors, and therefore can be considered blind.
measure: Sleep
time frame: 1-2 weeks
description: Nocturnal sleep duration, quality, and regularity, as measured by wrist-mounted accelerometry (actigraphy). Although in theory there are upper limits on healthy sleep, in practice during adolescence better health is associated with longer nocturnal sleep, better sleep quality, and greater night-to-night consistency in sleep patterns.
measure: Concussion Symptoms
time frame: 1-2 weeks
description: A primary outcome for the observational phase of the study, and a secondary outcome for the intervention phase, will be the Post-Concussion Symptom Scale (PCSS). On the PCSS, 21 common symptoms after concussion are rated on a 0-6 scale; for this study the focus will be on the summed total across items. Higher scores indicate greater symptom severity.
arm group label: Sleep Intervention
arm group type: Experimental
description: 1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration.
arm group label: Control
arm group type: No Intervention
description: In this "care as usual" arm, no specific behavioral sleep intervention is provided.
intervention type: Behavioral
intervention name: Sleep Intervention
description: The study therapist will outline the biopsychosocial model of mTBI recovery, highlighting the shift from biological injury to behavior (especially sleep behavior) as key driver of symptoms. The intervention will then apply well-established strategies from the pediatric psychology and insomnia literatures, encouraging conjoint problem-solving by parent and youth with the shared goal of maximizing nocturnal sleep. These include: pre-planning, problem-solving, development of a positive routine, commitment to sleep-promoting behaviors, self-monitoring, and positive reinforcement. The therapist will also teach a brief, self-guided pre-sleep relaxation exercise that has been used in insomnia treatment to maximize the benefit of additional sleep opportunity.
arm group label: Sleep Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Dean W Beebe, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: Undecided
ipd description: A deidentified data set may be available to qualified researchers who share specific research idea with the central contact person (Dr. Beebe, PI).