NCT04742998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

February 2, 2021

Last Update Submit

July 21, 2023

Conditions

Keywords

speech deficittumor pathologies of the upper aero-digestive tract

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Human perceptual score - Direct transcription

    Day 1

  • Human perceptual score - jury transcription

    Day 1

  • Head and Neck Carcinologic Handicap Index (HNCHI)

    Day 1

Study Arms (1)

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

Other: Acoustic-phonetic decoding task (DAP)

Interventions

Completion of speech-related quality of life autoquestionnaires Routine speech assessment Acoustic-phonetic decoding task (DAP) two lists of 16 pseudo-words

Patients treated for an oral or oropharyngeal tumor for at least 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All site have an active group of person allowing a feasibility of recruitment

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AP- H Marseille - Hôpital de la Conception

Marseille, France

RECRUITING

Institut universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

NOT YET RECRUITING

University Hospital Toulouse

Toulouse, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31734664BACKGROUND
  • 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.

    PMID: 32666294BACKGROUND
  • 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.

    PMID: 32598209BACKGROUND

MeSH Terms

Conditions

Speech Intelligibility

Condition Hierarchy (Ancestors)

SpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • Clémence DEVOUCOUX

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 8, 2021

Study Start

October 22, 2021

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations