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临床试验/NCT04437394
NCT04437394已完成不适用

Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

Yavuz Atar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Ankylosing spondylitis disease activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Ankylosing spondylitis
  • Person who accept to consent form

排除标准

  • Pulmoner diseases
  • Laryngeal polip or nodules
  • Underwent to larynx or esophageal surgery
  • Central nerve system diseases

结局指标

主要结局

Ankylosing spondylitis disease activity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Demographic values(3 months)

研究者

发起方
Yavuz Atar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yavuz Atar

Lecturer

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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