Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

Ankylosing Spondylitis Clinical Trial

Official title:

Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437394
• Other study ID #: 903-19/06/2018
• Status: Completed
• Start date: June 30, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: June 2020
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Deglutition Disorders
• Spondylitis
• Spondylitis, Ankylosing
• Swallowing Disorder.Other Specified
• Voice Alteration

Intervention

Diagnostic Test:
• flexible endoscopic evaluation of swallowing
The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
• The analysis of voice
Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yavuz Atar

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. Epub 2004 Mar 29. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of swallowing	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
Primary	Values of aspiration	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
Primary	Voice analysis	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
Primary	Cervical spine situation	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
Primary	Ankylosing spondylitis disease activity	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	Demographic values	Demographic values were assessed as age (18-70) ,education and gender (male or female).	3 months