Head and Neck CancerNCT05865756
Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features
A study testing Acoustic cough features analysis in people with Head and Neck Cancer and Dysphagia, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Dysphagia
- What is being tested?
- Acoustic cough features analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -pulmonary diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Dysphagia
- Being tested
- Acoustic cough features analysis
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic cough features analysisOther
Acoustic cough features analysis
| Study group | Role | What they receive |
|---|---|---|
| Cough and voice analysis in HNC patients | Other | Patients will undergo acoustic cough features analysis. Receives: Other: Acoustic cough features analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at least 3 months post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Apr 2021
- Primary completion1 Jun 2023
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865756
- Sponsor's protocol ID
- CE2762
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2178528McGarvey 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.
PubMed 10319055Waito 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.
PubMed 20454806
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Radio(Chemo)Therapy-related Dysphagia in Head and Neck Cancer Patients Based on Cough-related Acoustic Features
- ClinicalTrials.gov ID
- NCT05865756
- Acronym / sponsor ID
- CE2762
- Conditions
- Head and Neck Cancer, Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cough and voice analysis in HNC patients | Other | Other: Acoustic cough features analysisPatients will undergo acoustic cough features analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -pulmonary diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic cough features analysisAcoustic cough features analysis | Other | Cough and voice analysis in HNC patients |
Primary outcome
acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 2178528Irwin 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.
- Background: PubMed 10319055McGarvey 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.
- Background: PubMed 20454806Waito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic cough features analysis in people with Head and Neck Cancer and Dysphagia, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acoustic cough features in HNC patients as biomarkers for dysphagia/aspiration. (time frame: at least 3 months post-RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865756, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.