Clinical trial NCT06856863: Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
Official title: Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laryngectomy
Total Pharyngo-laryngectomy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: After total laryngectomy and loss of laryngeal phonation, the oro-oesophageal voice (VOO) is a communication option for the patient. It involves little financial outlay and, when mastered, ensures functional communication, but requires time-consuming speech therapy. VOO acquisition depends on a number of factors, including the patient's physiology, personality and socio-cultural environment. Several authors have suggested the influence of psychology on failure to learn VOO, but the studies found in the literature are old and did not use personality tests to objectivize this link through quantitative analysis. Today, the Temperament and Character Inventory (TCI-125) is a personality test used clinically and in research, and appreciated for the quantitative scores it provides.

The aim of our study is to ascertain whether salient personality traits (as measured by the TCI) are common to patients who succeed in learning VOO, compared with those who do not.

40 subjects who underwent total laryngectomy and had access to speech therapy will be included in this study. A speech assessment with audio recording will be performed and acoustic measurements will be taken. Subjects will also take the TCI-125. Finally, a perceptual evaluation by a jury of experts will categorize the subjects as good or poor speakers.

Inclusion period: 24 months Duration of subject participation: 1 day Total duration: 36 months


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years of age
* French-speaking patients
* MoCA score ≥ 16/26
* Patients who have undergone laryngectomy or total pharyngo-laryngectomy between 6 months and 5 years of age
* Patients who have agreed to learn VOO
* Patients who began speech therapy to learn VOO no more than 2 years ago
* Patients who have had access to speech therapy for VOO learning for at least 6 months (completed or ongoing)
* Patient who has received information about the study and has not expressed opposition
* Patients who are beneficiaries or entitled beneficiaries of a social security scheme

Exclusion Criteria:

* Patients who have undergone laryngectomy or total pharyngo-laryngectomy for more than 5 years
* Patients who have not received speech therapy to learn VOO post-operatively, or who have had access to therapy for less than 6 months
* Patients with an associated pathology that precludes VOO training (anatomical or physiological anomaly, esophageal stenosis)
* Patients with an associated pathology possibly responsible for speech or fluency disorders (developmental, organic or functional speech and language disorders, stuttering, stammering, fluency disorders, neurological speech disorders).
* Patients with unaidable hearing loss
* Patients unable to receive informed information about ongoing research due to impaired psychological or physical health
* MoCA score \<16/26
* Patients in a period of exclusion from another research protocol at the time of collection of the non-opposition.
* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women, etc.).

Primary outcomes:
measure: TCI-defined personality traits in patients able to learn VOO and those unable to learn VOO
timeFrame: From enrollement to the end of the study at 36 months
Secondary outcomes:
measure: Comparison of the sub-scores of the 7 dimensions of the TCI questionnaire
timeFrame: From enrollment to the end of the study at 36 months
measure: Measurement of VOO quality (cepstral peak proeminence in dB) from audio recordings between the two groups (able and unable the learn VOO)
timeFrame: From enrollment to the end of the study at 36 months
measure: Measurement of speech rate (in syllables/second)
timeFrame: From enrollment to the end of the study at 36 months
measure: Measurement of articulatory speed (in syllables / seconds excluding pauses)
timeFrame: From enrollment to the end of the study at 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References: