<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/NCT01674179</url>
  </required_header>
  <id_info>
    <org_study_id>SM 10-26</org_study_id>
    <nct_id>NCT01674179</nct_id>
  </id_info>
  <brief_title>Quantitative EEG During PSG in Patients With and Without Fibromyalgia</brief_title>
  <acronym>FMQEEG-10-26</acronym>
  <official_title>Quantitative EEG During PSG in Patients With and Without Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SouthCoast Medical Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SouthCoast Medical Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to retrospectively analyze Clinical and Nocturnal&#xD;
      Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.&#xD;
&#xD;
      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent&#xD;
      awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during&#xD;
      routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha&#xD;
      intrusions may be an objective marker for Fibromyalgia and may correlate with current&#xD;
      clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Retrospective Study of patients with and without Fibromyalgia seen in private&#xD;
      practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)&#xD;
&#xD;
      The polysomnographic and clinical data from research subjects with a diagnosis of&#xD;
      Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred&#xD;
      for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement,&#xD;
      Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.&#xD;
&#xD;
      Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2.&#xD;
      Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on&#xD;
      Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College&#xD;
      of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of&#xD;
      anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ),&#xD;
      Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).&#xD;
&#xD;
      Sleep Study Data Points: The following data points will be captured from Overnight Sleep&#xD;
      Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset,&#xD;
      4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7.&#xD;
      Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Delta Event/Alpha Event Ratios in Non-REM sleep</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">560</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>ACR diagnosis of Fibromyalgia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without Fibromyalgia</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Private Sleep Practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed a polysomnogram&#xD;
&#xD;
          -  Complaints of disordered sleep&#xD;
&#xD;
          -  Age 18 to 80 inclusive&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of seizure&#xD;
&#xD;
          -  use of benzodiazepines&#xD;
&#xD;
          -  use of AEDs&#xD;
&#xD;
          -  any significant medical condition other than disorder sleep or fibromyalgia that would&#xD;
             influence qEEG measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victor Rosenfeld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SouthCoast Medical Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SouthCoast Medical Group</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 10, 2010</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SouthCoast Medical Group</investigator_affiliation>
    <investigator_full_name>Victor Rosenfeld MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <keyword>qEEG</keyword>
  <keyword>Sleep</keyword>
  <keyword>Pain</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>
  <!-- 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/NCT01674179
org study id: SM 10-26
nct id: NCT01674179
lead sponsor: 
has dmc: No
The purpose of this study is to retrospectively analyze Clinical and Nocturnal
      Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.

      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent
      awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during
      routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha
      intrusions may be an objective marker for Fibromyalgia and may correlate with current
      clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.
This is a Retrospective Study of patients with and without Fibromyalgia seen in private
      practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)

      The polysomnographic and clinical data from research subjects with a diagnosis of
      Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred
      for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement,
      Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.

      Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2.
      Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on
      Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College
      of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of
      anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ),
      Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).

      Sleep Study Data Points: The following data points will be captured from Overnight Sleep
      Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset,
      4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7.
      Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.
observational model: Case-Control
time perspective: Retrospective
measure: Delta Event/Alpha Event Ratios in Non-REM sleep
time frame: up to 24 weeks
description: Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia
arm group label: ACR diagnosis of Fibromyalgia
arm group label: Patients without Fibromyalgia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Victor Rosenfeld, MD
role: Principal Investigator
affiliation: SouthCoast Medical Group
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: SouthCoast Medical Group
investigator full name: Victor Rosenfeld MD
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes