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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04742998
Other study ID # RC31/20/0551
Secondary ID 2020-A02335-34
Status Recruiting
Phase
First received
Last updated
Start date October 22, 2021
Est. completion date October 22, 2024

Study information

Verified date July 2023
Source University Hospital, Toulouse
Contact Clémence DEVOUCOUX
Phone 06.50.72.24.85
Email devoucoux.c@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date October 22, 2024
Est. primary completion date October 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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

Locations

Country Name City State
France AP- H Marseille - Hôpital de la Conception Marseille
France Institut universitaire du Cancer de Toulouse - Oncopole Toulouse
France University Hospital Toulouse Toulouse

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Toulouse IRIT - Institut de Recherche en Informatique de Toulouse, Laboratoire Information Avignon université, Laboratoire parole et langage

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Secondary 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. Day 1
Secondary 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 Day 1
Secondary Head and Neck Carcinologic Handicap Index (HNCHI) Correlation between HNCHI and scores from the DAP Day 1
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