跳至主要内容
临床试验/NCT05865756
NCT05865756进行中(未招募)不适用

Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features

Jules Bordet Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration.

研究概览

简要总结

To develop this objective and easily implementable assessment method of coughing based on acoustic features of voluntary and reflex coughs, there is a primary need in identifying and comparing acoustic cough features in healthy subjects and different disease-related coughs features. Cough is a common reason for seeking medical care. Chronic cough, defined as a cough that has lasted for longer that eight weeks, represents 10-38% of all referrals made to respiratory physicians [1-2]. Furthermore, between 60 and 80% of patients with chronic obstructivepulmonary disease (COPD) report cough. Following this pilot study comparing different populations, the applicability of the selected acoustic cough features should be examined in HNC patients with radiotherapy-induced dysphagia, Another frequent aspect of the clinical diagnostic examination of swallowing is perceptual analysis of voice quality immediately following deglutition. Changes in voice quality are assumed to provide information on the possible accumulation of saliva or food at the vocal folds level. It is reported that a change of voice may indicate laryngeal dysfunction or the presence of a foreign body at the laryngeal level [3] confirm that a normophonic voice after swallowing reflects a lack of aspiration-penetration. However, research shows that there is no strong correlation between aspiration and changes in perceptual voice quality (e.g. wet voice). A more reliable and easily implementable method could be detection of specific acoustic features of changes in voice quality.

详细描述

The ultimate goal of this study is to develop an innovative and non-invasive assessment method for dysphagia and aspiration in head and neck cancer (HNC) patients using acoustic features related to voluntary and/or reflex cough as biomarkers of dysphagia and/or aspiration in this population.

Additionally, the relationship between acoustic features and aerodynamic cough and acoustic voice parameters will be investigated, extending our insight in pathophysiology of dysphagia in this population.

To the investigators knowledge, no acoustic features of coughing and throat clearing in the frame of dysphagia have ever been explored. Regarding voice quality abnormalities, no acoustic parameters of reasonable evidence of dysphagia have been found.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration.

时间窗: at least 3 months post-RT

cough and voice analysis (using voice recording and frequencies obtained) of HNC patients post RT will be analysed to detect early diagnosis biomarkers for dysphagia/aspiration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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