<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/NCT03794908</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00151160</org_study_id>
    <secondary_id>1R21NR016930-01A1</secondary_id>
    <nct_id>NCT03794908</nct_id>
  </id_info>
  <brief_title>Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome</brief_title>
  <official_title>Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect a morning light treatment has on&#xD;
      improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia&#xD;
      syndrome (FMS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 2021</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The outcome assessors and participants were blinded to condition. The PI and lab manager remained unblinded, and performed the fidelity and side-effects assessments. Participants were asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score</measure>
    <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)</time_frame>
    <description>The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test</measure>
    <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)</time_frame>
    <description>Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test</measure>
    <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).</time_frame>
    <description>Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score</measure>
    <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).</time_frame>
    <description>Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>FMS</condition>
  <arm_group>
    <arm_group_label>Light therapy A (Bright) via the Re-Timer®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 minutes/day&#xD;
For the first hour after waking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Light therapy B (Dim) via the Re-Timer®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 minutes/day&#xD;
For the first hour after waking</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Light therapy A (Bright) via the Re-Timer®</intervention_name>
    <description>Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.</description>
    <arm_group_label>Light therapy A (Bright) via the Re-Timer®</arm_group_label>
    <other_name>Re-Timer®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Light therapy B (Dim) via the Re-Timer®</intervention_name>
    <description>Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.</description>
    <arm_group_label>Light therapy B (Dim) via the Re-Timer®</arm_group_label>
    <other_name>Re-Timer®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Meet criteria for Fibromyalgia syndrome (FMS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant chronic disease&#xD;
&#xD;
          -  Severe hearing or memory problems&#xD;
&#xD;
          -  Pending medical leave applications at workplace&#xD;
&#xD;
          -  Current pregnancy, breastfeeding, or actively trying to get pregnant&#xD;
&#xD;
          -  Night work or travel outside the eastern time zone within 1 month of the study&#xD;
&#xD;
          -  Other research participation&#xD;
&#xD;
          -  Frequent number of special events during study period (weddings, concerts, exams,&#xD;
             etc).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Burgess</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://is.gd/Fibrolight</url>
    <description>Additional study information and application to apply for study</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>July 14, 2022</results_first_submitted>
  <results_first_submitted_qc>September 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 5, 2022</results_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Helen Burgess</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Circadian timing</keyword>
  <keyword>Pain</keyword>
  <keyword>Light</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After scientific papers are accepted for publication and the data will be available for 7 years after study completion.</ipd_time_frame>
    <ipd_access_criteria>Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03794908/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03794908/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>60 participants were enrolled, and 57 participants were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Light Therapy A (Bright) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
        </group>
        <group group_id="P2">
          <title>Light Therapy B (Dim) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Began Use of Re-Timer</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Light Therapy A (Bright) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
        </group>
        <group group_id="B2">
          <title>Light Therapy B (Dim) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</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="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.3" spread="13.7"/>
                    <measurement group_id="B2" value="42.4" spread="13.1"/>
                    <measurement group_id="B3" value="41.8" spread="13.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apnea-Hypopnea Index</title>
          <description>Number of pauses in breath per hour during nighttime sleep.</description>
          <population>Participants who elected not to wear the watchPAT device were not included in the analysis.</population>
          <units>Events per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.33" spread="14.3"/>
                    <measurement group_id="B2" value="11.2" spread="10.2"/>
                    <measurement group_id="B3" value="14.0" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score</title>
        <description>The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.</description>
        <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Light Therapy A (Bright) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
          <group group_id="O2">
            <title>Light Therapy B (Dim) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
        </group_list>
        <measure>
          <title>Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score</title>
          <description>The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.</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="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="13.2"/>
                    <measurement group_id="O2" value="45.3" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-Treatment (completed 2 Weeks following baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" spread="13.5"/>
                    <measurement group_id="O2" value="39.4" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment (completed 4 Weeks following baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" spread="12.3"/>
                    <measurement group_id="O2" value="32.7" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of between-arm difference at mid-treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.49</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.03</ci_lower_limit>
            <ci_upper_limit>10.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of between-arm difference at end of treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.44</ci_lower_limit>
            <ci_upper_limit>11.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test</title>
        <description>Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful.</description>
        <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)</time_frame>
        <population>Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Light Therapy A (Bright) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
          <group group_id="O2">
            <title>Light Therapy B (Dim) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
        </group_list>
        <measure>
          <title>Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test</title>
          <description>Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful.</description>
          <population>Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.</population>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="3.3"/>
                    <measurement group_id="O2" value="41.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-Treatment (completed 2 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" spread="3.5"/>
                    <measurement group_id="O2" value="41.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment (completed 4 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" spread="3.1"/>
                    <measurement group_id="O2" value="42.6" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test</title>
        <description>Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop.</description>
        <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).</time_frame>
        <population>Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Light Therapy A (Bright) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
          <group group_id="O2">
            <title>Light Therapy B (Dim) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
        </group_list>
        <measure>
          <title>Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test</title>
          <description>Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop.</description>
          <population>Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.</population>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" spread="1.8"/>
                    <measurement group_id="O2" value="46.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-Treatment (completed 2 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.9" spread="1.6"/>
                    <measurement group_id="O2" value="46.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment (completed 4 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" spread="1.5"/>
                    <measurement group_id="O2" value="46.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score</title>
        <description>Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain.</description>
        <time_frame>Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Light Therapy A (Bright) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
          <group group_id="O2">
            <title>Light Therapy B (Dim) Via the Re-Timer®</title>
            <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score</title>
          <description>Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" spread="5.6"/>
                    <measurement group_id="O2" value="51.6" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-Treatment (completed 2 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.8" spread="5.5"/>
                    <measurement group_id="O2" value="50.4" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment (completed 4 weeks post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.9" spread="4.4"/>
                    <measurement group_id="O2" value="49.6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 5 weeks.</time_frame>
      <desc>Systematic Assessment for Treatment Emergent Events (SAFTEE) Questionnaire, a self-reported measure of physical and emotional symptoms experienced in the past week.</desc>
      <group_list>
        <group group_id="E1">
          <title>Light Therapy A (Bright) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</description>
        </group>
        <group group_id="E2">
          <title>Light Therapy B (Dim) Via the Re-Timer®</title>
          <description>60 minutes/day&#xD;
For the first hour after waking&#xD;
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®.</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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Helen Burgess</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-615-8303</phone>
      <email>bhelen@umich.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/NCT03794908
org study id: HUM00151160
secondary id: 1R21NR016930-01A1
nct id: NCT03794908
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine the effect a morning light treatment has on
      improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia
      syndrome (FMS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: The outcome assessors and participants were blinded to condition. The PI and lab manager remained unblinded, and performed the fidelity and side-effects assessments. Participants were asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.
measure: Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
description: The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.
measure: Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test
time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
description: Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful.
measure: Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test
time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
description: Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop.
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score
time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
description: Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain.
arm group label: Light therapy A (Bright) via the Re-Timer®
arm group type: Experimental
description: 60 minutes/day
For the first hour after waking
arm group label: Light therapy B (Dim) via the Re-Timer®
arm group type: Active Comparator
description: 60 minutes/day
For the first hour after waking
intervention type: Device
intervention name: Light therapy A (Bright) via the Re-Timer®
description: Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
arm group label: Light therapy A (Bright) via the Re-Timer®
other name: Re-Timer®
intervention type: Device
intervention name: Light therapy B (Dim) via the Re-Timer®
description: Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
arm group label: Light therapy B (Dim) via the Re-Timer®
other name: Re-Timer®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helen Burgess
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
url: https://is.gd/Fibrolight
description: Additional study information and application to apply for study
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Helen Burgess
investigator title: Professor of Psychiatry
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Yes
ipd description: The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
ipd access criteria: Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 