<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/NCT04437394</url>
  </required_header>
  <id_info>
    <org_study_id>903-19/06/2018</org_study_id>
    <nct_id>NCT04437394</nct_id>
  </id_info>
  <brief_title>Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients</brief_title>
  <official_title>Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yavuz Atar</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>
      In this study was to determine whether changes that occurred over time had an impact on the&#xD;
      swallowing and voice functions depend of Ankylosing spondylitis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was carried out at the University of Health Sciences Okmeydani Training and&#xD;
      Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and&#xD;
      30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified&#xD;
      New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic&#xD;
      swallowing evaluation was performed. Voice recordings were taken from the patients to&#xD;
      evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2018</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of swallowing</measure>
    <time_frame>3 months</time_frame>
    <description>Quality of swallowing was assessed by Eating Assessment Tool inventory consisting in 10 questions that scores from 0 to 40. Low score is better, higher score is worse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Values of aspiration</measure>
    <time_frame>3 months</time_frame>
    <description>Aspiration was assessed by aspiration penetration scale during swallowing with flexible endoscopy. The scale consisting in 8 degree that scored from 1 to 8. Higher score is worse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voice analysis</measure>
    <time_frame>3 months</time_frame>
    <description>Voice recordings were analyzed by PRAAT computer software. The investigator measured to shimmer, jitter and HNR voice values. The values are variation of frequency and amplitude of the sound wave. Higher value shows healthy voice for HNR parameters, lower value shows healthy voice for shimmer and jitter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervical spine situation</measure>
    <time_frame>3 months</time_frame>
    <description>Cervical spine was assessed with modify stoke ankylosing spondylitis spine score that scored from 0 to 3. Low score is better and high score is worse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ankylosing spondylitis disease activity</measure>
    <time_frame>3 months</time_frame>
    <description>The investigator measured to disease activity with bath ankylosing spondylitis disease activity index consisting in 6 questions that scored from 0 to 10 and morning rigidity times. Low scores are better and high scores are worse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic values</measure>
    <time_frame>3 months</time_frame>
    <description>Demographic values were assessed as age (18-70) ,education and gender (male or female).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Swallowing Disorder.Other Specified</condition>
  <condition>Voice Alteration</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Control group was performed on 30 participants who were healthy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>flexible endoscopic evaluation of swallowing</intervention_name>
    <description>The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The analysis of voice</intervention_name>
    <description>Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using&#xD;
        modified New York criterion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Ankylosing spondylitis&#xD;
&#xD;
          -  Person who accept to consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmoner diseases&#xD;
&#xD;
          -  Laryngeal polip or nodules&#xD;
&#xD;
          -  Underwent to larynx or esophageal surgery&#xD;
&#xD;
          -  Central nerve system diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yavuz Atar, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu 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>Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.</citation>
    <PMID>15051621</PMID>
  </results_reference>
  <results_reference>
    <citation>Kelly AM, Drinnan MJ, Leslie P. Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope. 2007 Oct;117(10):1723-7. doi: 10.1097/MLG.0b013e318123ee6a.</citation>
    <PMID>17906496</PMID>
  </results_reference>
  <results_reference>
    <citation>Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.</citation>
    <PMID>19140539</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Ankylosing spondylitis, swallowing, voice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <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/NCT04437394
org study id: 903-19/06/2018
nct id: NCT04437394
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study was to determine whether changes that occurred over time had an impact on the
      swallowing and voice functions depend of Ankylosing spondylitis patients.
This study was carried out at the University of Health Sciences Okmeydani Training and
      Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and
      30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified
      New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic
      swallowing evaluation was performed. Voice recordings were taken from the patients to
      evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
observational model: Cohort
time perspective: Cross-Sectional
measure: Quality of swallowing
time frame: 3 months
description: Quality of swallowing was assessed by Eating Assessment Tool inventory consisting in 10 questions that scores from 0 to 40. Low score is better, higher score is worse.
measure: Values of aspiration
time frame: 3 months
description: Aspiration was assessed by aspiration penetration scale during swallowing with flexible endoscopy. The scale consisting in 8 degree that scored from 1 to 8. Higher score is worse.
measure: Voice analysis
time frame: 3 months
description: Voice recordings were analyzed by PRAAT computer software. The investigator measured to shimmer, jitter and HNR voice values. The values are variation of frequency and amplitude of the sound wave. Higher value shows healthy voice for HNR parameters, lower value shows healthy voice for shimmer and jitter.
measure: Cervical spine situation
time frame: 3 months
description: Cervical spine was assessed with modify stoke ankylosing spondylitis spine score that scored from 0 to 3. Low score is better and high score is worse.
measure: Ankylosing spondylitis disease activity
time frame: 3 months
description: The investigator measured to disease activity with bath ankylosing spondylitis disease activity index consisting in 6 questions that scored from 0 to 10 and morning rigidity times. Low scores are better and high scores are worse.
measure: Demographic values
time frame: 3 months
description: Demographic values were assessed as age (18-70) ,education and gender (male or female).
arm group label: Study group
description: Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
arm group label: Control group
description: Control group was performed on 30 participants who were healthy.
intervention type: Diagnostic Test
intervention name: flexible endoscopic evaluation of swallowing
description: The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
arm group label: Control group
arm group label: Study group
intervention type: Diagnostic Test
intervention name: The analysis of voice
description: Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
arm group label: Control group
arm group label: Study group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yavuz Atar, Assoc. Prof.
role: Study Director
affiliation: University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital
facility: 
country: Turkey
citation: Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.
PMID: 15051621
citation: Kelly AM, Drinnan MJ, Leslie P. Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope. 2007 Oct;117(10):1723-7. doi: 10.1097/MLG.0b013e318123ee6a.
PMID: 17906496
citation: Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
PMID: 19140539
responsible party type: Sponsor-Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: Yavuz Atar
investigator title: Lecturer
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Deglutition Disorders
sharing ipd: No