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

NCT05865756 | Active Not Recruiting

• 1 other identifier: CE2762
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cough and voice analysis in HNC patients

OTHER

Patients will undergo acoustic cough features analysis.

Other: Acoustic cough features analysis

Interventions

Acoustic cough features analysis OTHER

Acoustic cough features analysis

Cough and voice analysis in HNC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pulmonary diseases.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Related Publications (3)

• Irwin RS, Curley FJ, French CL. Chronic cough. The spectrum and frequency of causes, key components of the diagnostic evaluation, and outcome of specific therapy. Am Rev Respir Dis. 1990 Mar;141(3):640-7. doi: 10.1164/ajrccm/141.3.640.

  PMID: 2178528 BACKGROUND

• McGarvey LP, Heaney LG, Lawson JT, Johnston BT, Scally CM, Ennis M, Shepherd DR, MacMahon J. Evaluation and outcome of patients with chronic non-productive cough using a comprehensive diagnostic protocol. Thorax. 1998 Sep;53(9):738-43. doi: 10.1136/thx.53.9.738.

  PMID: 10319055 BACKGROUND

• Waito A, Bailey GL, Molfenter SM, Zoratto DC, Steele CM. Voice-quality abnormalities as a sign of dysphagia: validation against acoustic and videofluoroscopic data. Dysphagia. 2011 Jun;26(2):125-34. doi: 10.1007/s00455-010-9282-4. Epub 2010 May 8.

  PMID: 20454806 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 19, 2023
• Study Start: April 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)