<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/NCT01683799</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00044088</org_study_id>
    <secondary_id>R21AG041942-01A1</secondary_id>
    <nct_id>NCT01683799</nct_id>
  </id_info>
  <brief_title>Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis</brief_title>
  <official_title>Slow Wave Sleep and Inflammatory Processes in Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose if the study is to determine whether improving sleep, especially slow wave or&#xD;
      &quot;deep&quot; sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity&#xD;
      and inflammatory responses to pain, and improves OA-related pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in minutes of time in slow wave sleep</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in relative power of delta EEG activity to index slow wave sleep activity</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in nociception flexion reflex threshold</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in electrocutaneous pain threshold</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in inflammatory cytokine responses to pain</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Western Ontario and McMaster University OA Index</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Knee Pain Scale score</measure>
    <time_frame>baseline and 10 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <condition>Insomnia</condition>
  <condition>Knee Pain</condition>
  <arm_group>
    <arm_group_label>Insomnia treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
    <description>6-week behavioral treatment for insomnia</description>
    <arm_group_label>Insomnia treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-75 years of age (for women, post-menopausal)&#xD;
&#xD;
          -  Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees&#xD;
&#xD;
          -  knee pain on most days for ≥ 6 months&#xD;
&#xD;
          -  self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling,&#xD;
             ascending or descending stairs, or performing daily activities&#xD;
&#xD;
          -  willing and able to avoid all prescription and non-prescription, non-opiate pain&#xD;
             medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks&#xD;
             prior to testing&#xD;
&#xD;
          -  meets research diagnostic criteria for sleep maintenance insomnia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  health conditions with immunological components or undergoing or taking&#xD;
             immunosuppressive therapies&#xD;
&#xD;
          -  conditions contraindicated for or potentially limiting ability to conduct NFR and/or&#xD;
             cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory&#xD;
             conditions; leg/hip nerve damage; BMI ≥ 32)&#xD;
&#xD;
          -  sleep disorders other than insomnia&#xD;
&#xD;
          -  dementia or cognitive impairment&#xD;
&#xD;
          -  history of schizophrenia or bipolar I disorder; current or recent history (within 3&#xD;
             months) of major psychiatric disorders&#xD;
&#xD;
          -  current depressive symptomatology or current suicidality&#xD;
&#xD;
          -  active substance dependence&#xD;
&#xD;
          -  untreated hypertension&#xD;
&#xD;
          -  use of antidepressants (stable use for 3 months okay), antipsychotics, mood&#xD;
             stabilizers, sedative-hypnotics, opiate analgesics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathi L. Heffner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wilfred Pigeon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 28, 2016</last_update_submitted>
  <last_update_submitted_qc>September 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kathi Heffner</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Cognitive Behavioral Therapy for Insomnia</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Inflammatory cytokines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683799
org study id: RSRB00044088
secondary id: R21AG041942-01A1
nct id: NCT01683799
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose if the study is to determine whether improving sleep, especially slow wave or
      "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity
      and inflammatory responses to pain, and improves OA-related pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Change from baseline in minutes of time in slow wave sleep
time frame: baseline and 10 weeks
measure: Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
time frame: baseline and 10 weeks
measure: Change from baseline in nociception flexion reflex threshold
time frame: baseline and 10 weeks
measure: Change from baseline in electrocutaneous pain threshold
time frame: baseline and 10 weeks
measure: Change from baseline in inflammatory cytokine responses to pain
time frame: baseline and 10 weeks
measure: Change from baseline in Western Ontario and McMaster University OA Index
time frame: baseline and 10 weeks
measure: Change from baseline in Knee Pain Scale score
time frame: baseline and 10 weeks
arm group label: Insomnia treatment
arm group type: Experimental
description: Cognitive Behavioral Therapy for Insomnia
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia
description: 6-week behavioral treatment for insomnia
arm group label: Insomnia treatment
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kathi L. Heffner, PhD
role: Principal Investigator
affiliation: University of Rochester
last name: Wilfred Pigeon, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kathi Heffner
investigator title: Associate Professor of Psychiatry
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Sleep Initiation and Maintenance Disorders