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Recruiting NCT06856863

NCT06856863 Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice

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Clinical Trial Summary
NCT ID NCT06856863
Status Recruiting
Phase
Sponsor Assistance Publique Hopitaux De Marseille
Condition Laryngectomy
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2025-10-14
Primary Completion 2027-10-14

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Test of personality : questionnary

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2025-10-14 with a primary completion date of 2027-10-14.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 ≥ 16/30 * 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 Exclusion Criteria: * 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) * 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.).

Contact & Investigator

Central Contact

Camille Galant

✉ promotion.interne@ap-hm.fr

📞 0491435817

Frequently Asked Questions

Who can join the NCT06856863 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Laryngectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06856863 currently recruiting?

Yes, NCT06856863 is actively recruiting participants. Contact the research team at promotion.interne@ap-hm.fr for enrollment information.

Where is the NCT06856863 trial being conducted?

This trial is being conducted at Marseille, France.

Who is sponsoring the NCT06856863 clinical trial?

NCT06856863 is sponsored by Assistance Publique Hopitaux De Marseille. The trial plans to enroll 40 participants.

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