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

Sponsor
Jules Bordet Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865756
Collaborator
(none)
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41
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Acoustic cough features analysis
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
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.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)
Primary Purpose:
Screening
Official Title:
Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Cough and voice analysis in HNC patients

Patients will undergo acoustic cough features analysis.

Other: Acoustic cough features analysis
Acoustic cough features analysis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Jules Bordet Brussels Belgium 1070

Sponsors and Collaborators

  • Jules Bordet Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dirk Van Gestel, Pr, Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT05865756
Other Study ID Numbers:
  • CE2762
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023