<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/NCT01674998</url>
  </required_header>
  <id_info>
    <org_study_id>11-DAT-013</org_study_id>
    <nct_id>NCT01674998</nct_id>
  </id_info>
  <brief_title>Understanding the Natural History of REM Sleep Behavior Disorder</brief_title>
  <official_title>Understanding Autonomic Function in REM Sleep Behavior Disorder, Parkinsonism and Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Parkinson's Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Parkinson's Institute</source>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine if safe, simple and non-invasive tests&#xD;
      such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify&#xD;
      neurological disorders before typical symptoms occur. Researchers believe that early&#xD;
      identification of these disorders could lead to treatments to prevent, delay, or slow the&#xD;
      development of one of more of these diseases. Some people with REM sleep behavior disorder&#xD;
      (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but&#xD;
      many do not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">15</enrollment>
  <condition>REM Sleep Behavior Disorder</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and/or saliva DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sleep disorders clinics Neurology practices Medical practices Sleep disorders support&#xD;
        groups Web-based advertisements Community outreach&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic REM sleep behavior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease&#xD;
&#xD;
          -  Alzheimer's disease&#xD;
&#xD;
          -  Multiple system atrophy&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Minors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Parkinson's Institute</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94085</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sak Sundarrajan</last_name>
      <phone>800-786-2958</phone>
      <phone_ext>434</phone_ext>
      <email>sleepstudy@thepi.org</email>
    </contact>
    <contact_backup>
      <last_name>Kathleen Comyns, MPH</last_name>
      <phone>800-786-2958</phone>
      <phone_ext>434</phone_ext>
      <email>sleepstudy@thepi.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Parkinson's Institute</investigator_affiliation>
    <investigator_full_name>J. William Langston</investigator_full_name>
    <investigator_title>Founder and CEO</investigator_title>
  </responsible_party>
  <keyword>REM Sleep Behavior Disorder</keyword>
  <keyword>RBD</keyword>
  <keyword>Dream</keyword>
  <keyword>Dreams</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>REM Sleep Behavior Disorder</mesh_term>
    <mesh_term>Mental 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/NCT01674998
org study id: 11-DAT-013
nct id: NCT01674998
lead sponsor: 
The purpose of this research study is to determine if safe, simple and non-invasive tests
      such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify
      neurological disorders before typical symptoms occur. Researchers believe that early
      identification of these disorders could lead to treatments to prevent, delay, or slow the
      development of one of more of these diseases. Some people with REM sleep behavior disorder
      (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but
      many do not.
observational model: Case-Only
time perspective: Cross-Sectional
Blood and/or saliva DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Parkinson's Institute
investigator full name: J. William Langston
investigator title: Founder and CEO
mesh term: REM Sleep Behavior Disorder
mesh term: Mental Disorders