<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/NCT02982239</url>
  </required_header>
  <id_info>
    <org_study_id>1605615210</org_study_id>
    <nct_id>NCT02982239</nct_id>
  </id_info>
  <brief_title>Recovery Enhancement and Sleep Training</brief_title>
  <acronym>REST</acronym>
  <official_title>Recovery Enhancement and Sleep Training (REST): Sleep and Mental Well-Being in Student Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Collegiate Athletic Association - NCAA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</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>
      Evidence suggests that student athletes frequently experience sleep problems and are aware of&#xD;
      the impact of sleep loss on mental and physical outcomes. As such, student athletes are&#xD;
      motivated to improve sleep quality in order to improve their outcomes for overall athletic&#xD;
      performance. This study will consist of two parts. The first part will be a survey. Fall&#xD;
      athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a&#xD;
      survey within the first week of their arrival on campus. The survey will assess multiple&#xD;
      domains of student-athlete health, namely, sleep duration and quality, mood and depression,&#xD;
      stress, and mental and physical well-being. The responses to the survey will be confidential,&#xD;
      and students will be compensated for the survey. At the end of the semester, students will be&#xD;
      invited to complete the survey again.&#xD;
&#xD;
      Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the&#xD;
      intervention, based on predetermined criteria. The intervention will include an information&#xD;
      session where students may ask questions. Students will be sent text message reminders about&#xD;
      adherence to the program and will be asked to monitor their sleep quality with sleep diaries.&#xD;
      The intervention will consist of the half of the 40 chosen students, (20 students), who will&#xD;
      be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit&#xD;
      bit. Please note that all of these items are commercially available and are not meant to be&#xD;
      used to treat or prevent human illness nor injury and do not require FDA oversight. The&#xD;
      blue-blocking glasses will ensure that blue light from electronic devices will not interfere&#xD;
      with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright&#xD;
      LED light will provide bright blue light in the morning to help students wake and an amber&#xD;
      light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as&#xD;
      well as adherence to the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Student athletes face many challenges to their ability to maintain healthy mental and&#xD;
      physical well-being. The college experience is associated with a number of physiologic,&#xD;
      social, and environmental stressors that can exert long-term effects on an individual's&#xD;
      future health and quality of life. In addition, unique demands of student-athletes, including&#xD;
      academic, physical performance, scheduling, and travel demands, all represent additional&#xD;
      stressors that interact to produce in poorer outcomes.&#xD;
&#xD;
      Insufficient sleep duration and poor sleep quality have been increasingly identified as&#xD;
      important risk factors for physical and mental well-being, especially among young adults. For&#xD;
      example, insufficient and/or poor quality sleep is strongly associated with the development&#xD;
      of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use,&#xD;
      other substance use, poorer academic performance, and reduced mental well-being, in addition&#xD;
      to poorer athletic performance.&#xD;
&#xD;
      Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of&#xD;
      flexible time is the hardest thing about being an athlete, more than academic work. Further,&#xD;
      students identified sleep as the first thing that their athletic time commitments kept them&#xD;
      from doing, 77% felt that they got less sleep than non-athletes, and &gt;50% indicated that they&#xD;
      would use an extra hour to catch up on sleep. In 2015 data from the American College Health&#xD;
      Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40%&#xD;
      reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime&#xD;
      sleepiness, (4) &gt;15% reported sleepiness to be at least &quot;a big problem,&quot; (5) &gt;25% reported&#xD;
      extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia),&#xD;
      and (6) &gt;50% reported that sleep problems impacted academic performance. Thus,&#xD;
      student-athletes frequently experience sleep problems, they recognize the impact of sleep&#xD;
      loss, and they are likely motivated to improve sleep. These data are consistent with data&#xD;
      from professional athletes, whose overall sleep quality is poorer than non-athletes.&#xD;
&#xD;
      Taken together, sleep is an aspect of health that is implicated in many of the most salient&#xD;
      mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep&#xD;
      represents one of the greatest challenges facing student athletes. No programmatic approaches&#xD;
      have been able to address this problem.&#xD;
&#xD;
      Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep&#xD;
      health intervention targeted at student-athletes. This intervention will be assessed with and&#xD;
      without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules&#xD;
      in order to evaluate the utility of those approaches.&#xD;
&#xD;
      The purpose of this research study is to develop and assess the benefits of a novel sleep&#xD;
      health intervention targeted at student-athletes.&#xD;
&#xD;
      Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian&#xD;
      preference, and outcomes including overall mental health, stress, mood, anxiety, social&#xD;
      functioning, and physical well-being.&#xD;
&#xD;
      AIM 2: Determine whether a simple sleep health intervention, with and without the aid of&#xD;
      technology, is associated with improvements in mental and physical well-being.&#xD;
&#xD;
      Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score,&#xD;
      anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary&#xD;
      outcome variable(s) Academic stress, physical performance, substance use, health behaviors,&#xD;
      soft tissue injuries, missed practices, academic performance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">January 5, 2017</completion_date>
  <primary_completion_date type="Actual">January 4, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index ( PSQI)</measure>
    <time_frame>Change from baseline to post-intervention, around 10 weeks after baseline</time_frame>
    <description>Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
    <description>Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:&#xD;
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)</measure>
    <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
    <description>Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Centers for Epidemiological Studies Depression Scale (CESD)</measure>
    <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
    <description>Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
    <description>Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4 - &quot;Very often.&quot; Scores range from 0-56 higher scores indicate greater perceived stress.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sleep</condition>
  <condition>Performance</condition>
  <condition>Mental Health</condition>
  <condition>Stress</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>N=20 Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>N=20 Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Diary</intervention_name>
    <description>All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitness tracker</intervention_name>
    <description>All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blue-Blocking Glasses</intervention_name>
    <description>Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.</description>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LED light</intervention_name>
    <description>Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.</description>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information Session</intervention_name>
    <description>all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q&amp;A period.&#xD;
Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs.</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
    <other_name>Educational session</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text messages</intervention_name>
    <description>All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.</description>
    <arm_group_label>Sleep Intervention</arm_group_label>
    <arm_group_label>Sleep Intervention plus Tech</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate&#xD;
&#xD;
          -  Participation as a student-athlete during the entirety of their season&#xD;
&#xD;
          -  No medical conditions that would preclude them from participating (assessed by&#xD;
             self-report)&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Freshmen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>January 4, 2018</results_first_submitted>
  <results_first_submitted_qc>May 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2019</results_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Student-athletes were recruited over the summer and through the first 2 weeks of the 2015 Fall semester, as they arrived on campus. Recruitment was accomplished through flyers, referrals from athletics staff, and in-person recruitment among athletes at on campus athletic facilities.</recruitment_details>
      <pre_assignment_details>All students who completed the survey were eligible for the intervention study, though selection was targeted to those with sleep complaints.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention- No Tech</title>
          <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
        </group>
        <group group_id="P2">
          <title>Intervention -Tech</title>
          <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
        </group>
        <group group_id="B2">
          <title>Intervention -Tech</title>
          <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.56" spread="0.97"/>
                    <measurement group_id="B2" value="20.55" spread="0.93"/>
                    <measurement group_id="B3" value="20.55" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pittsburgh Sleep Quality Index ( PSQI)</title>
        <description>Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.</description>
        <time_frame>Change from baseline to post-intervention, around 10 weeks after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
          </group>
          <group group_id="O2">
            <title>Intervention -Tech</title>
            <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Pittsburgh Sleep Quality Index ( PSQI)</title>
          <description>Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.941176471" spread="2.9041046"/>
                    <measurement group_id="O2" value="6.555555556" spread="3.329409455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.647058824" spread="2.84914848"/>
                    <measurement group_id="O2" value="5.833333333" spread="2.7917947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Insomnia Severity Index (ISI)</title>
        <description>Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:&#xD;
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
        <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention- No Tech</title>
            <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
          </group>
          <group group_id="O2">
            <title>Intervention -Tech</title>
            <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Insomnia Severity Index (ISI)</title>
          <description>Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:&#xD;
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.529411765" spread="4.862068066"/>
                    <measurement group_id="O2" value="7.5" spread="3.944467458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.176470588" spread="4.034775305"/>
                    <measurement group_id="O2" value="5.266666667" spread="3.954503159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)</title>
        <description>Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.</description>
        <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
          </group>
          <group group_id="O2">
            <title>Intervention -Tech</title>
            <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)</title>
          <description>Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.</description>
          <units>Days out of 30</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>unhealthy mental health days Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.176470588" spread="10.30919065"/>
                    <measurement group_id="O2" value="7.555555556" spread="8.958874813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unhealthy Physical health days Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.411764706" spread="9.695738906"/>
                    <measurement group_id="O2" value="3.944444444" spread="6.803737919"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unhealthy mental health days Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.411764706" spread="8.000459546"/>
                    <measurement group_id="O2" value="4.611111111" spread="5.699730529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unhealthy physical health days Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.352941176" spread="9.512762325"/>
                    <measurement group_id="O2" value="6.833333333" spread="9.173170598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Centers for Epidemiological Studies Depression Scale (CESD)</title>
        <description>Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.</description>
        <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
          </group>
          <group group_id="O2">
            <title>Intervention -Tech</title>
            <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Centers for Epidemiological Studies Depression Scale (CESD)</title>
          <description>Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CESD total score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.294117647" spread="6.45914764"/>
                    <measurement group_id="O2" value="10.16666667" spread="7.957608272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CESD total score Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.470588235" spread="8.147987843"/>
                    <measurement group_id="O2" value="7.333333333" spread="6.962082177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Perceived Stress Scale (PSS)</title>
        <description>Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4 - &quot;Very often.&quot; Scores range from 0-56 higher scores indicate greater perceived stress.</description>
        <time_frame>Change from baseline to post intervention, around 10 weeks after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention- No Tech</title>
            <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks</description>
          </group>
          <group group_id="O2">
            <title>Intervention -Tech</title>
            <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress Scale (PSS)</title>
          <description>Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4 - &quot;Very often.&quot; Scores range from 0-56 higher scores indicate greater perceived stress.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.52941176" spread="7.072107598"/>
                    <measurement group_id="O2" value="21.27777778" spread="5.706606652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.05882353" spread="7.386394488"/>
                    <measurement group_id="O2" value="19.11111111" spread="7.379533613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Intervention -Tech</title>
          <description>Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Since this is considered a pilot study and is likely underpowered, the primary outcomes were assessed for change over time.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Michael Grandner</name_or_title>
      <organization>Sleep and Health Research Program - University of Arizona</organization>
      <phone>5206260105</phone>
      <email>grandner@psychiatry.arizona.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02982239
org study id: 1605615210
nct id: NCT02982239
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evidence suggests that student athletes frequently experience sleep problems and are aware of
      the impact of sleep loss on mental and physical outcomes. As such, student athletes are
      motivated to improve sleep quality in order to improve their outcomes for overall athletic
      performance. This study will consist of two parts. The first part will be a survey. Fall
      athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a
      survey within the first week of their arrival on campus. The survey will assess multiple
      domains of student-athlete health, namely, sleep duration and quality, mood and depression,
      stress, and mental and physical well-being. The responses to the survey will be confidential,
      and students will be compensated for the survey. At the end of the semester, students will be
      invited to complete the survey again.

      Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the
      intervention, based on predetermined criteria. The intervention will include an information
      session where students may ask questions. Students will be sent text message reminders about
      adherence to the program and will be asked to monitor their sleep quality with sleep diaries.
      The intervention will consist of the half of the 40 chosen students, (20 students), who will
      be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit
      bit. Please note that all of these items are commercially available and are not meant to be
      used to treat or prevent human illness nor injury and do not require FDA oversight. The
      blue-blocking glasses will ensure that blue light from electronic devices will not interfere
      with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright
      LED light will provide bright blue light in the morning to help students wake and an amber
      light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as
      well as adherence to the program.
Student athletes face many challenges to their ability to maintain healthy mental and
      physical well-being. The college experience is associated with a number of physiologic,
      social, and environmental stressors that can exert long-term effects on an individual's
      future health and quality of life. In addition, unique demands of student-athletes, including
      academic, physical performance, scheduling, and travel demands, all represent additional
      stressors that interact to produce in poorer outcomes.

      Insufficient sleep duration and poor sleep quality have been increasingly identified as
      important risk factors for physical and mental well-being, especially among young adults. For
      example, insufficient and/or poor quality sleep is strongly associated with the development
      of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use,
      other substance use, poorer academic performance, and reduced mental well-being, in addition
      to poorer athletic performance.

      Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of
      flexible time is the hardest thing about being an athlete, more than academic work. Further,
      students identified sleep as the first thing that their athletic time commitments kept them
      from doing, 77% felt that they got less sleep than non-athletes, and >50% indicated that they
      would use an extra hour to catch up on sleep. In 2015 data from the American College Health
      Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40%
      reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime
      sleepiness, (4) >15% reported sleepiness to be at least "a big problem," (5) >25% reported
      extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia),
      and (6) >50% reported that sleep problems impacted academic performance. Thus,
      student-athletes frequently experience sleep problems, they recognize the impact of sleep
      loss, and they are likely motivated to improve sleep. These data are consistent with data
      from professional athletes, whose overall sleep quality is poorer than non-athletes.

      Taken together, sleep is an aspect of health that is implicated in many of the most salient
      mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep
      represents one of the greatest challenges facing student athletes. No programmatic approaches
      have been able to address this problem.

      Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep
      health intervention targeted at student-athletes. This intervention will be assessed with and
      without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules
      in order to evaluate the utility of those approaches.

      The purpose of this research study is to develop and assess the benefits of a novel sleep
      health intervention targeted at student-athletes.

      Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian
      preference, and outcomes including overall mental health, stress, mood, anxiety, social
      functioning, and physical well-being.

      AIM 2: Determine whether a simple sleep health intervention, with and without the aid of
      technology, is associated with improvements in mental and physical well-being.

      Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score,
      anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary
      outcome variable(s) Academic stress, physical performance, substance use, health behaviors,
      soft tissue injuries, missed practices, academic performance
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pittsburgh Sleep Quality Index ( PSQI)
time frame: Change from baseline to post-intervention, around 10 weeks after baseline
description: Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
measure: Insomnia Severity Index (ISI)
time frame: Change from baseline to post intervention, around 10 weeks after baseline
description: Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
measure: Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
time frame: Change from baseline to post intervention, around 10 weeks after baseline
description: Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.
measure: Centers for Epidemiological Studies Depression Scale (CESD)
time frame: Change from baseline to post intervention, around 10 weeks after baseline
description: Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
measure: Perceived Stress Scale (PSS)
time frame: Change from baseline to post intervention, around 10 weeks after baseline
description: Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
arm group label: Sleep Intervention
arm group type: Other
description: N=20 Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
arm group label: Sleep Intervention plus Tech
arm group type: Other
description: N=20 Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
intervention type: Behavioral
intervention name: Sleep Diary
description: All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.
arm group label: Sleep Intervention
arm group label: Sleep Intervention plus Tech
intervention type: Device
intervention name: Fitness tracker
description: All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).
arm group label: Sleep Intervention
arm group label: Sleep Intervention plus Tech
intervention type: Device
intervention name: Blue-Blocking Glasses
description: Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.
arm group label: Sleep Intervention plus Tech
intervention type: Device
intervention name: LED light
description: Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.
arm group label: Sleep Intervention plus Tech
intervention type: Other
intervention name: Information Session
description: all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q&A period.
Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs.
arm group label: Sleep Intervention
arm group label: Sleep Intervention plus Tech
other name: Educational session
intervention type: Behavioral
intervention name: Text messages
description: All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.
arm group label: Sleep Intervention
arm group label: Sleep Intervention plus Tech
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Since this is considered a pilot study and is likely underpowered, the primary outcomes were assessed for change over time.
point of contact: 