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Clinical Trials/NCT04437394
NCT04437394
Completed
Not Applicable

Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

Yavuz Atar1 site in 1 country60 target enrollmentJune 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Yavuz Atar
Enrollment
60
Locations
1
Primary Endpoint
Ankylosing spondylitis disease activity
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2018
End Date
October 30, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yavuz Atar
Responsible Party
Sponsor Investigator
Principal Investigator

Yavuz Atar

Lecturer

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Demographic values(3 months)

Study Sites (1)

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