Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

Completed

• Conditions: Ankylosing Spondylitis; Voice Alteration; Swallowing Disorder.Other Specified
• Interventions: Diagnostic Test: flexible endoscopic evaluation of swallowing; Diagnostic Test: The analysis of voice

• Registration Number: NCT04437394
• Lead Sponsor: Yavuz Atar

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.

Study Timeline

• Study Start: 2018-06-30
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-17
• Study First Posted: 2020-06-18
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	The analysis of voice	Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Study group	flexible endoscopic evaluation of swallowing	Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Control group	flexible endoscopic evaluation of swallowing	Control group was performed on 30 participants who were healthy.
Control group	The analysis of voice	Control group was performed on 30 participants who were healthy.

Primary Outcome Measures

Name	Time	Method
Ankylosing spondylitis disease activity	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	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	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	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	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 Outcome Measures

Name	Time	Method
Demographic values	3 months	Demographic values were assessed as age (18-70) ,education and gender (male or female).

Trial Locations

Locations (1)

Prof Dr Cemil Tascioglu City Hospital; 🇹🇷 Istanbul, Turkey