Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

June 17, 2020 updated by: Yavuz Atar
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.

Description

Inclusion Criteria:

  • Diagnosed with Ankylosing spondylitis
  • Person who accept to consent form

Exclusion Criteria:

  • Pulmoner diseases
  • Laryngeal polip or nodules
  • Underwent to larynx or esophageal surgery
  • Central nerve system diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Diagnostic test: flexible endoscopic evaluation of swallowing
The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
Diagnostic test: The analysis of voice
Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
Control group
Control group was performed on 30 participants who were healthy.
Diagnostic test: flexible endoscopic evaluation of swallowing
The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
Diagnostic test: The analysis of voice
Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of swallowing
Time Frame: 3 months
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.
3 months
Values of aspiration
Time Frame: 3 months
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.
3 months
Voice analysis
Time Frame: 3 months
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.
3 months
Cervical spine situation
Time Frame: 3 months
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.
3 months
Ankylosing spondylitis disease activity
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic values
Time Frame: 3 months
Demographic values were assessed as age (18-70) ,education and gender (male or female).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yavuz Atar

Investigators

  • Study Director: Yavuz Atar, Assoc. Prof., University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 903-19/06/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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