Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice

NCT06856863 | Recruiting

• 2 other identifiers: RCAPHM25_00022025-A00022-47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Laryngectomy; Total Pharyngo-laryngectomy

Outcome Measures

Primary Outcomes (1)

• TCI-defined personality traits in patients able to learn VOO and those unable to learn VOO

  From enrollement to the end of the study at 36 months

Secondary Outcomes (4)

• Comparison of the sub-scores of the 7 dimensions of the TCI questionnaire

  From enrollment to the end of the study at 36 months

• Measurement of VOO quality (cepstral peak proeminence in dB) from audio recordings between the two groups (able and unable the learn VOO)

  From enrollment to the end of the study at 36 months

• Measurement of speech rate (in syllables/second)

  From enrollment to the end of the study at 36 months

• Measurement of articulatory speed (in syllables / seconds excluding pauses)

  From enrollment to the end of the study at 36 months

Study Arms (1)

Study of personality traits in patients able or unable to learn VOO

EXPERIMENTAL

Behavioral: Test of personality : questionnary

Interventions

Test of personality : questionnary BEHAVIORAL

The questionnary Temperament and Character Inventory (TCI) describes personality through temperament traits governed by the individual's neurobiological systems and predetermined by heredity; and character traits shaped by social and cognitive experience

Study of personality traits in patients able or unable to learn VOO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 18 years of age
• French-speaking patients
• MoCA score ≥ 16/30
• 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 five years ago
• Patients who have had access to speech therapy to learn VOO for at least six months (completed or ongoing)
• Patients who have received information about the study and have not expressed their opposition
• Patients who are beneficiaries of or entitled to social security coverage

You may not qualify if:

• Patients who underwent a laryngectomy or total pharyngolaryngectomy more than 5 years ago
• Patients who did not receive speech therapy to learn OVO postoperatively, or who received less than 6 months of therapy
• Patients with a related condition that prevents them from learning VOO (anatomical or physiological abnormality, esophageal stenosis)
• Patients with a related condition that may be responsible for speech or fluency disorders (developmental, organic, or functional speech and language disorders, stuttering, stammering, fluency disorders, neurological speech disorders)
• Patients with uncorrected hearing loss
• Patients unable to receive informed consent about the ongoing research due to impaired psychological or physical health
• MoCA score \<16/30
• Patients with definite depressive symptoms (HAD-D score ≥ 11)
• 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.).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

RECRUITING

Central Study Contacts

Camille Galant

CONTACT

0491435817; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): October 14, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (1)