Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Head and Neck Cancer, Dysphagia

Intervention / Treatment
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* Other: Acoustic cough features analysis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: HNC patients in complete clinical remission (10 male/10 female adults & 10 male/10 female elderly) Patients diagnosed with dysphagia (with evaluation by videofluoroscopy) Patients treated with radiochemotherapy and selected three months after the end of treatment. Exclusion criteria: -pulmonary diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: 40HNC patients in complete clinical remission (10 male/10 female adults & 10 male/10 female elderly) diagnosed with dysphagia treated with radiochemotherapy and selected three months after the end of treatment will be submitted to cough and voice analysis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cough and voice analysis in HNC patients<br>Patients will undergo acoustic cough features analysis. | Other: Acoustic cough features analysis<br>* Acoustic cough features analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration. | 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 | at least 3 months post-RT |