- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04742998
Task of Acoustic-phonetic Decoding on Anatomic Deficits in Paramedical Assessment of Speech Disorders for Patients Treated for Oral or Oropharyngeal Cancer (DAPADAF-E)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clémence DEVOUCOUX
- Phone Number: +33 06.50.72.24.85
- Email: devoucoux.c@chu-toulouse.fr
Study Contact Backup
- Name: Anaïs GALTIER
- Phone Number: +33 05. 67. 77. 18 .70
- Email: Galtier.a@chu-toulouse.fr
Study Locations
-
-
-
Marseille, France
- Recruiting
- AP- H Marseille - Hôpital de la Conception
-
Contact:
- Camille GALANT
- Phone Number: 06 28 43 14 23
- Email: camille.galant@ap-hm.fr
-
Principal Investigator:
- Camille GALANT
-
Toulouse, France
- Recruiting
- University Hospital Toulouse
-
Contact:
- Clémence DEVOUCOUX
- Phone Number: 06.50.72.24.85
- Email: devoucoux.c@chu-toulouse.fr
-
Principal Investigator:
- Clémence DEVOUCOUX
-
Sub-Investigator:
- Anaïs GALTIER
-
Toulouse, France
- Not yet recruiting
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
Contact:
- Pauline CHAUSSIER
- Phone Number: 05 31 15 55 04
- Email: chaussier.pauline@iuct-oncopole.fr
-
Principal Investigator:
- Pauline CHAUSSIER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients treated for an oral or oropharyngeal tumor for at least 6 months
|
Completion of speech-related quality of life autoquestionnaires Routine speech assessment Acoustic-phonetic decoding task (DAP) two lists of 16 pseudo-words
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Human perceptual score - Direct transcription
Time Frame: Day 1
|
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.
|
Day 1
|
Human perceptual score - jury transcription
Time Frame: Day 1
|
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
|
Day 1
|
Head and Neck Carcinologic Handicap Index (HNCHI)
Time Frame: Day 1
|
Correlation between HNCHI and scores from the DAP
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Clémence DEVOUCOUX, University Hospital, Toulouse
Publications and helpful links
General 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.
- Balaguer 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.
- Lalain 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Language Disorders
- Communication Disorders
- Oropharyngeal Neoplasms
- Speech Disorders
Other Study ID Numbers
- RC31/20/0551
- 2020-A02335-34 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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