<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/NCT03779243</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-48700</org_study_id>
    <nct_id>NCT03779243</nct_id>
  </id_info>
  <brief_title>Treatment for Sleep Disturbance in Orthopaedic Trauma Patients</brief_title>
  <official_title>Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test the efficacy of sleep treatment in human patients&#xD;
      following traumatic injury. Specifically, the study will determine if treatment consisting of&#xD;
      melatonin and education related to sleep habits are effective in treating sleep disturbance&#xD;
      and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and&#xD;
      sleep education effectively improve sleep following traumatic injury, and improve outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">August 24, 2021</completion_date>
  <primary_completion_date type="Actual">August 24, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Pittsburgh Sleep Quality Index Score</measure>
    <time_frame>Baseline, week 6, and week 12</time_frame>
    <description>9-item self-rated questionnaire that assesses clinical sleep quality and disturbances. Global PSQI scores are sums of the component scores, and range from 0-21. Higher scores indicate worse sleep quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey (SF-36) to measure quality of life</measure>
    <time_frame>Baseline, week 6, and week 12</time_frame>
    <description>36-item, patient-reported survey of patient health-related quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)</measure>
    <time_frame>Baseline, week 6, and week 12</time_frame>
    <description>VAS is scored on a continuum from 0-10 indicating &quot;no pain&quot; to &quot;unbearable pain&quot;. Higher scores indicate more pain intensity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>5mg Melatonin and Sleep Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 5mg Melatonin nightly, 1 hour before bedtime and be provided educational materials to improve sleep hygiene. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be given placebo pills to be taken daily 1 hour before bedtime and are a &quot;sleep aid&quot;. Participants will not receive any sleep education materials. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Melatonin 5mg and Sleep Education</intervention_name>
    <description>Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.</description>
    <arm_group_label>5mg Melatonin and Sleep Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily placebo pills for 6 weeks following injury or surgery.</description>
    <arm_group_label>Placebo Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patients visiting the Orthopaedic Trauma Clinic or undergoing orthopaedic surgery&#xD;
             in Stanford Hospital following traumatic injury. Accidental traumatic fracture&#xD;
             injuries that are operative and non-operative. Must be able to swallow tablets.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented head trauma. Cognitive impairments. Minors. Previously diagnosed sleep&#xD;
             disorders. Sleep apnea. Enrolled in another study. Women who are pregnant or may&#xD;
             become pregnant or are nursing. Hypertension. Diabetes. Endocrine, autoimmune,&#xD;
             depressive, bleeding or seizure disorders.&#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>Michael J Gardner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Department of Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Swann MC, Batty M, Hu G, Mitchell T, Box H, Starr A. Sleep Disturbance in Orthopaedic Trauma Patients. J Orthop Trauma. 2018 Oct;32(10):500-504. doi: 10.1097/BOT.0000000000001276.</citation>
    <PMID>30086043</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Michael J. Gardner</investigator_full_name>
    <investigator_title>PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779243
org study id: IRB-48700
nct id: NCT03779243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to test the efficacy of sleep treatment in human patients
      following traumatic injury. Specifically, the study will determine if treatment consisting of
      melatonin and education related to sleep habits are effective in treating sleep disturbance
      and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and
      sleep education effectively improve sleep following traumatic injury, and improve outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: double-blind
measure: Mean Change in Pittsburgh Sleep Quality Index Score
time frame: Baseline, week 6, and week 12
description: 9-item self-rated questionnaire that assesses clinical sleep quality and disturbances. Global PSQI scores are sums of the component scores, and range from 0-21. Higher scores indicate worse sleep quality.
measure: 36-Item Short Form Survey (SF-36) to measure quality of life
time frame: Baseline, week 6, and week 12
description: 36-item, patient-reported survey of patient health-related quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
measure: Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
time frame: Baseline, week 6, and week 12
description: VAS is scored on a continuum from 0-10 indicating "no pain" to "unbearable pain". Higher scores indicate more pain intensity.
arm group label: 5mg Melatonin and Sleep Education
arm group type: Experimental
description: Participants will take 5mg Melatonin nightly, 1 hour before bedtime and be provided educational materials to improve sleep hygiene. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Participants will be given placebo pills to be taken daily 1 hour before bedtime and are a "sleep aid". Participants will not receive any sleep education materials. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.
intervention type: Dietary Supplement
intervention name: Melatonin 5mg and Sleep Education
description: Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
arm group label: 5mg Melatonin and Sleep Education
intervention type: Other
intervention name: Placebo
description: Daily placebo pills for 6 weeks following injury or surgery.
arm group label: Placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Gardner, MD
role: Principal Investigator
affiliation: Stanford Department of Orthopaedic Surgery
facility: 
country: United States
citation: Swann MC, Batty M, Hu G, Mitchell T, Box H, Starr A. Sleep Disturbance in Orthopaedic Trauma Patients. J Orthop Trauma. 2018 Oct;32(10):500-504. doi: 10.1097/BOT.0000000000001276.
PMID: 30086043
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Michael J. Gardner
investigator title: PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Wounds and Injuries
mesh term: Melatonin
sharing ipd: No