Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedJune 19, 2020
June 1, 2020
4 months
June 16, 2020
June 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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 Outcomes (1)
Demographic values
3 months
Study Arms (2)
Study group
Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Control group
Control group was performed on 30 participants who were healthy.
Interventions
The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
Eligibility Criteria
The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
You may qualify if:
- Diagnosed with Ankylosing spondylitis
- Person who accept to consent form
You may not qualify if:
- Pulmoner diseases
- Laryngeal polip or nodules
- Underwent to larynx or esophageal surgery
- Central nerve system diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yavuz Atarlead
Study Sites (1)
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384, Turkey (Türkiye)
Related Publications (4)
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: 15051621RESULTKelly 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: 17906496RESULTBelafsky 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: 19140539RESULTAhmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.
PMID: 34259915DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yavuz Atar, Assoc. Prof.
University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
June 30, 2018
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
June 19, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share