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Completed

NCT Number: NCT04437394

Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Dysphonia Joint Diseases Laryngeal Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Swallowing Disorder.Other Specified Voice Alteration Voice Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test

The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.

The analysis of voice

Diagnostic Test

Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Demographic values

    Time frame: 3 months

    Demographic values were assessed as age (18-70) ,education and gender (male or female).

Sponsors and collaborators

Lead sponsor

Yavuz Atar

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2020
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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