<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/NCT04465903</url>
  </required_header>
  <id_info>
    <org_study_id>298</org_study_id>
    <nct_id>NCT04465903</nct_id>
  </id_info>
  <brief_title>Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire</brief_title>
  <official_title>Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</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>
      Purpose of the study is the validity and reliability of the Turkish version of the Sydney&#xD;
      Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish&#xD;
      dysphagia patients. Despite being translated and validated in many languages, there is no&#xD;
      validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The swallow function is a multidirectional process that depends on complex neuro-muscular&#xD;
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic&#xD;
      evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There&#xD;
      are many questionnaire and scales for assessment of swallow but very few have been validated.&#xD;
      The study will assess the construct validity and reliability of the Turkish version of&#xD;
      Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators&#xD;
      developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural&#xD;
      adaptation guidelines. Two translators translated the SSQ into Turkish and a native English&#xD;
      language speaker reverse-translated it into English. The back translation was sent to the&#xD;
      original author for proofreading. The SSQ questionnaire consisted of 17 basic questions&#xD;
      related with dysphagia symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Turkish Version of Sydney Swallow Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Turkish Version of Sydney Swallow Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
    <description>Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Assessment Tool</measure>
    <time_frame>Baseline</time_frame>
    <description>The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penetration and aspiration scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>YALE scale of pharyngeal residue</measure>
    <time_frame>Baseline</time_frame>
    <description>The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subject demographics</measure>
    <time_frame>Baseline</time_frame>
    <description>The median values of age and ratio of gender in all groups</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">170</enrollment>
  <condition>Dysphagia, Oropharyngeal</condition>
  <condition>Swallowing Disorder</condition>
  <condition>Validation</condition>
  <arm_group>
    <arm_group_label>Dysphagia patients</arm_group_label>
    <description>The first group consists of 85 dysphagia patients who have at least six months of dysphagia complaints. The participants will given the Turkish version of Sydney Swallow questionnaire (SSQ-T), consisted of 17 questions, eating assessment tool-10 and two scales evaluated with FEES. After the two weeks, 30 participants will given the SSQ-T for sampling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Turkish Version of Sydney Swallow Questionnaire</intervention_name>
    <description>The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.</description>
    <arm_group_label>Dysphagia patients</arm_group_label>
    <arm_group_label>Healthy adults</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with oropharyngeal dysphagia and healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group 1:&#xD;
&#xD;
          -  Able to speak, read, understand and write in Turkish&#xD;
&#xD;
          -  History of dysphagia during 6 months&#xD;
&#xD;
          -  Age between 18-80 years&#xD;
&#xD;
        Group 2:&#xD;
&#xD;
          -  Able to speak, read, understand and write in Turkish&#xD;
&#xD;
          -  Healthy adults&#xD;
&#xD;
          -  Age between 18-80 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Cognitive limitations&#xD;
&#xD;
          -  Able not to speak, read, understand and write in Turkish&#xD;
&#xD;
          -  Underwent any surgery last a month&#xD;
&#xD;
          -  Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Malignancies&#xD;
&#xD;
          -  Out of age 18-80 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melis Ece Arkan Ararat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof. Dr. Cemil Tascıoglu City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ugur Uygan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof. Dr. Cemil Tascıoglu City Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prof Dr Cemil Tascioglu City Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34384</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Arenaz Bua B, Bulow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742.</citation>
    <PMID>25330714</PMID>
  </results_reference>
  <results_reference>
    <citation>Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1.</citation>
    <PMID>30707281</PMID>
  </results_reference>
  <results_reference>
    <citation>Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery. Dysphagia. 2012 Dec;27(4):491-7. doi: 10.1007/s00455-012-9395-z. Epub 2012 Feb 21.</citation>
    <PMID>22350113</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.</citation>
    <PMID>10734019</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
    <investigator_full_name>Yavuz Atar</investigator_full_name>
    <investigator_title>Associate Professor, MD</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/NCT04465903
org study id: 298
nct id: NCT04465903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of the study is the validity and reliability of the Turkish version of the Sydney
      Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish
      dysphagia patients. Despite being translated and validated in many languages, there is no
      validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.
The swallow function is a multidirectional process that depends on complex neuro-muscular
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic
      evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There
      are many questionnaire and scales for assessment of swallow but very few have been validated.
      The study will assess the construct validity and reliability of the Turkish version of
      Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators
      developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural
      adaptation guidelines. Two translators translated the SSQ into Turkish and a native English
      language speaker reverse-translated it into English. The back translation was sent to the
      original author for proofreading. The SSQ questionnaire consisted of 17 basic questions
      related with dysphagia symptoms.
observational model: Other
time perspective: Prospective
measure: Turkish Version of Sydney Swallow Questionnaire
time frame: Baseline
description: Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions.
measure: Turkish Version of Sydney Swallow Questionnaire
time frame: 2 weeks
description: Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions.
measure: Eating Assessment Tool
time frame: Baseline
description: The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
measure: Penetration and aspiration scale
time frame: Baseline
description: The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.
measure: YALE scale of pharyngeal residue
time frame: Baseline
description: The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.
measure: Subject demographics
time frame: Baseline
description: The median values of age and ratio of gender in all groups
arm group label: Dysphagia patients
description: The first group consists of 85 dysphagia patients who have at least six months of dysphagia complaints. The participants will given the Turkish version of Sydney Swallow questionnaire (SSQ-T), consisted of 17 questions, eating assessment tool-10 and two scales evaluated with FEES. After the two weeks, 30 participants will given the SSQ-T for sampling.
arm group label: Healthy adults
description: The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.
intervention type: Other
intervention name: Turkish Version of Sydney Swallow Questionnaire
description: The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
arm group label: Dysphagia patients
arm group label: Healthy adults
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melis Ece Arkan Ararat, MD
role: Principal Investigator
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
last name: Ugur Uygan, MD
role: Principal Investigator
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
facility: 
country: Turkey
citation: Arenaz Bua B, Bulow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742.
PMID: 25330714
citation: Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1.
PMID: 30707281
citation: Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery. Dysphagia. 2012 Dec;27(4):491-7. doi: 10.1007/s00455-012-9395-z. Epub 2012 Feb 21.
PMID: 22350113
citation: Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.
PMID: 10734019
responsible party type: Principal Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: Yavuz Atar
investigator title: Associate Professor, MD
mesh term: Deglutition Disorders
sharing ipd: No