<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/NCT01662427</url>
  </required_header>
  <id_info>
    <org_study_id>6222012</org_study_id>
    <nct_id>NCT01662427</nct_id>
  </id_info>
  <brief_title>Nocturnal Parkinson's Disease Symptoms Study Group</brief_title>
  <official_title>Nocturnal Parkinson's Disease Symptoms Study Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <brief_summary>
    <textblock>
      To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in&#xD;
      Parkinson's disease patients and caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To assess Noctural Parkinson's Disease Symptoms</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess quality of life in Parkinson's Disease patient</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess quality of life in caregiver of Parkinson's Disease patient</measure>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Questionniare</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionaire to assess Noctural Parkinson's Disease Symptoms</intervention_name>
    <description>Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life</description>
    <arm_group_label>Questionniare</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson's disease patient and care givers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Idiopathic Parkinson's disease patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular&#xD;
             Parkinsonism, exposure to toxin, Encephalitis&#xD;
&#xD;
          2. Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive&#xD;
             Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)&#xD;
&#xD;
          3. Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's&#xD;
             disease, Juvenile Huntington's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Roongroj Bhidayasiri</name>
      <address>
        <city>Pathumwan</city>
        <state>Bangkok</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 18, 2013</last_update_submitted>
  <last_update_submitted_qc>August 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Roongroj Bhidayasiri</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Quality of life</keyword>
  <keyword>Noctural Parkinson's Disease Symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT01662427
org study id: 6222012
nct id: NCT01662427
lead sponsor: 
To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in
      Parkinson's disease patients and caregivers.
observational model: Cohort
time perspective: Prospective
measure: To assess Noctural Parkinson's Disease Symptoms
measure: To assess quality of life in Parkinson's Disease patient
measure: To assess quality of life in caregiver of Parkinson's Disease patient
arm group label: Questionniare
intervention type: Other
intervention name: Questionaire to assess Noctural Parkinson's Disease Symptoms
description: Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life
arm group label: Questionniare
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Roongroj Bhidayasiri
investigator title: Associate Professor
mesh term: Parkinson Disease