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Trial Title:
Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features
NCT ID:
NCT05865756
Condition:
Head and Neck Cancer
Dysphagia
Conditions: Official terms:
Head and Neck Neoplasms
Deglutition Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Acoustic cough features analysis
Description:
Acoustic cough features analysis
Arm group label:
Cough and voice analysis in HNC patients
Summary:
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:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Start date:
April 1, 2021
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05865756
