<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/NCT03241615</url>
  </required_header>
  <id_info>
    <org_study_id>HACETTEPEUNIVERSITY</org_study_id>
    <nct_id>NCT03241615</nct_id>
  </id_info>
  <brief_title>Dysphagia Symptom Severity and Quality of Life</brief_title>
  <official_title>The Relationship Between Dysphagia Symptom Severity and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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 aim of the study is to investigate the relationship between dysphagia symptom severity&#xD;
      and quality of life of the patients with neurogenic dysphagia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dysphagia related quality of life and perceived dysphagia symptom severity by patients&#xD;
      will be used as a complementary information on oropharyngeal dysphagia. Thus, the aim of the&#xD;
      study is to investigate the relationship between dysphagia symptom severity and quality of&#xD;
      life of the patients with neurogenic dysphagia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">September 8, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</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>Dysphagia symptom severity</measure>
    <time_frame>1 month</time_frame>
    <description>Dysphagia symptom severity will be determined by an eating assessment tool.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>Swallowing related quality of life will be determined by an dysphagia specific quality of life instrument called Swallow Quality of Life.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Neurogenic Dysphagia</condition>
  <arm_group>
    <arm_group_label>Neurogenic dysphagia</arm_group_label>
    <description>Patients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function ([24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included. Dysphagia evaluation will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dysphagia evaluation</intervention_name>
    <description>Dysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed.</description>
    <arm_group_label>Neurogenic dysphagia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have neurogenic dysphagia and willing to participate in the study, being over&#xD;
        the age of 20, normal cognitive function (24 points according to the Mini Mental State&#xD;
        Examination), and having clinically stable neurological disease will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to participate in the study&#xD;
&#xD;
          -  Being over the age of 20&#xD;
&#xD;
          -  Normal cognitive function&#xD;
&#xD;
          -  Suffering from dysphagia at least one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being under the age of 20 and above 65 years.&#xD;
&#xD;
          -  Abnormal cognitive function&#xD;
&#xD;
          -  Clinically unstable neurological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacetttepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SELEN SEREL ARSLAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_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/NCT03241615
org study id: HACETTEPEUNIVERSITY
nct id: NCT03241615
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the relationship between dysphagia symptom severity
      and quality of life of the patients with neurogenic dysphagia.
The dysphagia related quality of life and perceived dysphagia symptom severity by patients
      will be used as a complementary information on oropharyngeal dysphagia. Thus, the aim of the
      study is to investigate the relationship between dysphagia symptom severity and quality of
      life of the patients with neurogenic dysphagia.
observational model: Cohort
time perspective: Prospective
measure: Dysphagia symptom severity
time frame: 1 month
description: Dysphagia symptom severity will be determined by an eating assessment tool.
measure: Quality of life
time frame: 1 month
description: Swallowing related quality of life will be determined by an dysphagia specific quality of life instrument called Swallow Quality of Life.
arm group label: Neurogenic dysphagia
description: Patients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function ([24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included. Dysphagia evaluation will be performed.
intervention type: Other
intervention name: Dysphagia evaluation
description: Dysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed.
arm group label: Neurogenic dysphagia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
last name: SELEN SEREL ARSLAN
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SELEN SEREL ARSLAN
investigator title: Principal Investigator
mesh term: Deglutition Disorders
sharing ipd: No