Clinical trial NCT04437394: Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
Official title: Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Swallowing Disorder.Other Specified
Voice Alteration
Keywords: Ankylosing spondylitis, swallowing, voice
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Quality of swallowing
timeFrame: 3 months
measure: Values of aspiration
timeFrame: 3 months
measure: Voice analysis
timeFrame: 3 months
measure: Cervical spine situation
timeFrame: 3 months
measure: Ankylosing spondylitis disease activity
timeFrame: 3 months
Secondary outcomes:
measure: Demographic values
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Tascioglu City Hospital
Study officials:
affiliation: University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital
name: Yavuz Atar, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.
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. doi: 10.1097/MLG.0b013e318123ee6a.
citation: 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. doi: 10.1177/000348940811701210.
citation: Ahmed 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.