Speech IntelligibilityDAPADAF-ENCT04742998
Task of Acoustic-phonetic Decoding on Anatomic Deficits in Paramedical Assessment of Speech Disorders for Patients Treated for Oral or Oropharyngeal Cancer
An observational study of Speech Intelligibility, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Speech Intelligibility
- What is being tested?
- Acoustic-phonetic decoding task (DAP)
- Type of treatment
- Pill or oral medicine
- How many people
- 116 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Oct 2021to 22 Oct 2024
- Phase
- Observational
- 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
Study population: All site have an active group of person allowing a feasibility of recruitment
Who may be able to join
- Patients aged at least 18 years old and benefiting from a social security scheme
- Native French-speaking patients
- Patients treated for cancer of the oral cavity or oropharynx (surgical and / or radiotherapy and / or chemotherapy treatment)
- Patients in clinical remission for at least 6 months (chronic nature and stability of the disorders)
- All tumor sizes according to the tumor (T), node (N), and metastasis (M) categories (TNM classification) (T1 to T4)
- Patients with a perceptible speech disorder in a conversational situation or not (to allow the determination of fine deficits)
- Patients who do not object to carrying out the research
Who cannot join
- Patients with an associated pathology potentially responsible for speech or fluency disorders (joint, speech and language disorders of developmental, organic or functional origin, voice disorders of organic or functional origin, stammering , stammering, fluency disturbances, speech disturbances of neurological origin)
- Patients reporting an auditory complaint and not having a hearing aid
- Inability to provide the person with enlightened information and to ensure the subject's compliance because of impaired physical and / or psychological health,
- Patients participating in another research including an exclusion period still in progress.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
AP- H Marseille - Hôpital de la Conception
Marseille
Camille GALANT, 06 28 43 14 23, camille.galant@ap-hm.fr
Camille GALANT
- Not yet recruiting
Institut universitaire du Cancer de Toulouse - Oncopole
Toulouse
Pauline CHAUSSIER, 05 31 15 55 04, chaussier.pauline@iuct-oncopole.fr
Pauline CHAUSSIER
- Recruiting
University Hospital Toulouse
Toulouse
Clémence DEVOUCOUX, 06.50.72.24.85, devoucoux.c@chu-toulouse.fr
Clémence DEVOUCOUX
About this study
Official title: Validity of a Task of Acoustic-phonetic Decoding on Anatomic Deficits in Paramedical Assessment of Speech Disorders for Patients Treated for Oral or Oropharyngeal Cancer
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. the production of isolated pseudo-words in repetition or reading), created within the framework of the The French National Cancer Institute (InCA) C2SI project, avoids the effects of cognitive restoration by the interlocutor. An automatic score from the DAP would lead to an overall score per patient, but also to scores specific to each phonetic segment, to be correlated with the analytical scores from each anatomical oropharyngeal segment.
The study hypothesis is that the automatic processing of an acoustic-phonetic decoding task during the assessment in current practice is a valid and reliable tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
The study hypothesis is that the automatic processing of an acoustico-phonetic decoding task during the assessment in current practice is a tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
Read the detailed description
Fifth cancer in terms of incidence in France, tumor pathologies of the upper aero-digestive tract, due to their location, impact the speech abilities of affected subjects. Speech therapy in paramedical clinical assessments consist of two parts.
- The analytical part to highlight the anatomical and dynamic deficits of segments involved in speech.
- The functional part characterizes the pathophysiological impact by means of an "ear" assessment.
The link between anatomy and functional speech deficit is very close in oncology (the location and the size of the tumor, the structural changes due to the treatment who modify the oropharyngeal dynamics and the mechanisms involved in the production of the speech), but the correlation is weak between functional intelligibility scores and analytical motor scores. Indeed, the perception of speech by a human listener is not a simple "recording" of the production, but a representation of this production after implementation of individual mechanisms for restoring the acoustic information linked to the lexicon or to the context by the listener. The listener's degree of familiarity with the speaker or his pathology is also a source of variability.
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. the production of isolated pseudo-words in repetition or reading), created within the framework of the InCA C2SI project, avoids the effects of cognitive restoration by the interlocutor. An automatic score from the DAP would lead to an overall score per patient, but also to scores specific to each phonetic segment, to be correlated with the analytical scores from each anatomical oropharyngeal segment.
The study hypothesis is that the automatic processing of an acoustic-phonetic decoding task during the assessment in current practice is a valid and reliable tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
- Conditions
- Speech Intelligibility
- Being tested
- Acoustic-phonetic decoding task (DAP)
- Keywords
- speech deficit, tumor pathologies of the upper aero-digestive tract
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic-phonetic decoding task (DAP)Other
Completion of speech-related quality of life autoquestionnaires Routine speech assessment Acoustic-phonetic decoding task (DAP) two lists of 16 pseudo-words
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for an oral or oropharyngeal tumor for at least 6 months | Patients treated for an oral or oropharyngeal tumor for at least 6 months Receives: Other: Acoustic-phonetic decoding task (DAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient
Correlation coefficient between he automatic score by phoneme class from the DAP and the score for each oropharyngeal anatomical segment from muscle testing
Measured: Day 1
Secondary outcomes (3)
Human perceptual score - Direct transcription
the speech therapist will transcribe the pseudo-word he thinks he has recognized immediately after the subject says it, using software installed on the examination computer. A perceptual score of linguistic traits of average difference (between expected production and perception by the speech therapist) by phoneme will then be determined.
Measured: Day 1
Human perceptual score - jury transcription
Audio recordings of the task will be made. A perceptual score of linguistic traits of average difference (between expected production and perception by the jury) by phoneme will then be determined
Measured: Day 1
Head and Neck Carcinologic Handicap Index (HNCHI)
Correlation between HNCHI and scores from the DAP
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start22 Oct 2021
- Primary completion22 Oct 2024 (estimated)
- Study completion22 Oct 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 Speech IntelligibilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire parole et langage, Laboratoire Information Avignon université, IRIT - Institut de Recherche en Informatique de Toulouse
- Responsible party
- Sponsor
- Investigators
- Clémence DEVOUCOUX, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742998
- Sponsor's protocol ID
- RC31/20/0551
- Other IDs
- 2020-A02335-34
- Acronym
- DAPADAF-E
- Status last verified
- Jul 2023
- First submitted
- 2 Feb 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balaguer M, Farinas J, Fichaux-Bourin P, Puech M, Pinquier J, Woisard V. Validation of the French Versions of the Speech Handicap Index and the Phonation Handicap Index in Patients Treated for Cancer of the Oral Cavity or Oropharynx. Folia Phoniatr Logop. 2020;72(6):464-477. doi: 10.1159/000503448. Epub 2019 Nov 15.
PubMed 31734664Balaguer M, Champenois M, Farinas J, Pinquier J, Woisard V. The (head and neck) carcinologic handicap index: validation of a modular type questionnaire and its ability to prioritise patients' needs. Eur Arch Otorhinolaryngol. 2021 Apr;278(4):1159-1169. doi: 10.1007/s00405-020-06201-6. Epub 2020 Jul 14.
PubMed 32666294Lalain M, Ghio A, Giusti L, Robert D, Fredouille C, Woisard V. Design and Development of a Speech Intelligibility Test Based on Pseudowords in French: Why and How? J Speech Lang Hear Res. 2020 Jul 20;63(7):2070-2083. doi: 10.1044/2020_JSLHR-19-00088. Epub 2020 Jun 29.
PubMed 32598209
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Task of Acoustic-phonetic Decoding on Anatomic Deficits in Paramedical Assessment of Speech Disorders for Patients Treated for Oral or Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04742998
- Acronym / sponsor ID
- DAPADAF-E / RC31/20/0551
- Conditions
- Speech Intelligibility
- Keywords
- speech deficit, tumor pathologies of the upper aero-digestive tract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Laboratoire parole et langage, Laboratoire Information Avignon université, IRIT - Institut de Recherche en Informatique de Toulouse
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 22 Oct 2024 (estimated)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 8 Feb 2021 (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.
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. the production of isolated pseudo-words in repetition or reading), created within the framework of the The French National Cancer Institute (InCA) C2SI project, avoids the effects of cognitive restoration by the interlocutor. An automatic score from the DAP would lead to an overall score per patient, but also to scores specific to each phonetic segment, to be correlated with the analytical scores from each anatomical oropharyngeal segment.
The study hypothesis is that the automatic processing of an acoustic-phonetic decoding task during the assessment in current practice is a valid and reliable tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
The study hypothesis is that the automatic processing of an acoustico-phonetic decoding task during the assessment in current practice is a tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
Detailed description
Fifth cancer in terms of incidence in France, tumor pathologies of the upper aero-digestive tract, due to their location, impact the speech abilities of affected subjects. Speech therapy in paramedical clinical assessments consist of two parts.
- The analytical part to highlight the anatomical and dynamic deficits of segments involved in speech.
- The functional part characterizes the pathophysiological impact by means of an "ear" assessment.
The link between anatomy and functional speech deficit is very close in oncology (the location and the size of the tumor, the structural changes due to the treatment who modify the oropharyngeal dynamics and the mechanisms involved in the production of the speech), but the correlation is weak between functional intelligibility scores and analytical motor scores. Indeed, the perception of speech by a human listener is not a simple "recording" of the production, but a representation of this production after implementation of individual mechanisms for restoring the acoustic information linked to the lexicon or to the context by the listener. The listener's degree of familiarity with the speaker or his pathology is also a source of variability.
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. the production of isolated pseudo-words in repetition or reading), created within the framework of the InCA C2SI project, avoids the effects of cognitive restoration by the interlocutor. An automatic score from the DAP would lead to an overall score per patient, but also to scores specific to each phonetic segment, to be correlated with the analytical scores from each anatomical oropharyngeal segment.
The study hypothesis is that the automatic processing of an acoustic-phonetic decoding task during the assessment in current practice is a valid and reliable tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for an oral or oropharyngeal tumor for at least 6 months | – | Other: Acoustic-phonetic decoding task (DAP)Patients treated for an oral or oropharyngeal tumor for at least 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All site have an active group of person allowing a feasibility of recruitment
Key inclusion criteria (7 listed)
- Patients aged at least 18 years old and benefiting from a social security scheme
- Native French-speaking patients
- Patients treated for cancer of the oral cavity or oropharynx (surgical and / or radiotherapy and / or chemotherapy treatment)
- Patients in clinical remission for at least 6 months (chronic nature and stability of the disorders)
- All tumor sizes according to the tumor (T), node (N), and metastasis (M) categories (TNM classification) (T1 to T4)
Key exclusion criteria (4 listed)
- Patients with an associated pathology potentially responsible for speech or fluency disorders (joint, speech and language disorders of developmental, organic or functional origin, voice disorders of organic or functional origin, stammering , stammering, fluency disturbances, speech disturbances of neurological origin)
- Patients reporting an auditory complaint and not having a hearing aid
- Inability to provide the person with enlightened information and to ensure the subject's compliance because of impaired physical and / or psychological health,
- Patients participating in another research including an exclusion period still in progress.
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-phonetic decoding task (DAP)Completion of speech-related quality of life autoquestionnaires Routine speech assessment Acoustic-phonetic decoding task (DAP) two lists of 16 pseudo-words | Other | Patients treated for an oral or oropharyngeal tumor for at least 6 months |
Primary outcome
Correlation coefficient
Time frame: Day 1
Correlation coefficient between he automatic score by phoneme class from the DAP and the score for each oropharyngeal anatomical segment from muscle testing
3 secondary outcomes
Human perceptual score - Direct transcription
Time frame: Day 1
Human perceptual score - jury transcription
Time frame: Day 1
Head and Neck Carcinologic Handicap Index (HNCHI)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 31734664Balaguer M, Farinas J, Fichaux-Bourin P, Puech M, Pinquier J, Woisard V. Validation of the French Versions of the Speech Handicap Index and the Phonation Handicap Index in Patients Treated for Cancer of the Oral Cavity or Oropharynx. Folia Phoniatr Logop. 2020;72(6):464-477. doi: 10.1159/000503448. Epub 2019 Nov 15.
- Background: PubMed 32666294Balaguer M, Champenois M, Farinas J, Pinquier J, Woisard V. The (head and neck) carcinologic handicap index: validation of a modular type questionnaire and its ability to prioritise patients' needs. Eur Arch Otorhinolaryngol. 2021 Apr;278(4):1159-1169. doi: 10.1007/s00405-020-06201-6. Epub 2020 Jul 14.
- Background: PubMed 32598209Lalain M, Ghio A, Giusti L, Robert D, Fredouille C, Woisard V. Design and Development of a Speech Intelligibility Test Based on Pseudowords in French: Why and How? J Speech Lang Hear Res. 2020 Jul 20;63(7):2070-2083. doi: 10.1044/2020_JSLHR-19-00088. Epub 2020 Jun 29.
- 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.
Clémence DEVOUCOUX principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Intelligibility, run by University Hospital, Toulouse at 3 sites in France.
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 7 inclusion and 4 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Contact Clémence DEVOUCOUX (06.50.72.24.85 ext. +33, devoucoux.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient (time frame: Day 1). 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 NCT04742998, 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 24 Jul 2023.