LaryngectomyCoPerVOONCT06856863
Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
A study testing Test of personality : questionnary in people with Laryngectomy and Total Pharyngo-laryngectomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy, Total Pharyngo-laryngectomy
- What is being tested?
- Test of personality : questionnary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2025to 14 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13005
Camille Galant, 0491435817 ext. 33, promotion.interne@ap-hm.fr
About this study
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.
Read more
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
- Being tested
- Test of personality : questionnary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of personality : questionnaryBehavioural
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 group | Role | What they receive |
|---|---|---|
| Study of personality traits in patients able or unable to learn VOO | Experimental | Not described Receives: Behavioral: Test of personality : questionnary |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCI-defined personality traits in patients able to learn VOO and those unable to learn VOO
Measured: 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
Measured: 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)
Measured: From enrollment to the end of the study at 36 months
Measurement of speech rate (in syllables/second)
Measured: From enrollment to the end of the study at 36 months
Measurement of articulatory speed (in syllables / seconds excluding pauses)
Measured: From enrollment to the end of the study at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start14 Oct 2025
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856863
- Sponsor's protocol ID
- RCAPHM25_0002
- Other IDs
- 2025-A00022-47
- Acronym
- CoPerVOO
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
- ClinicalTrials.gov ID
- NCT06856863
- Acronym / sponsor ID
- CoPerVOO / RCAPHM25_0002
- Conditions
- Laryngectomy, Total Pharyngo-laryngectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study of personality traits in patients able or unable to learn VOO | Experimental | Behavioral: Test of personality : questionnary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of personality : questionnaryThe 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 | Behavioural | Study of personality traits in patients able or unable to learn VOO |
Primary outcome
TCI-defined personality traits in patients able to learn VOO and those unable to learn VOO
Time frame: From enrollement to the end of the study at 36 months
4 secondary outcomes
Comparison of the sub-scores of the 7 dimensions of the TCI questionnaire
Time frame: 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)
Time frame: From enrollment to the end of the study at 36 months
Measurement of speech rate (in syllables/second)
Time frame: From enrollment to the end of the study at 36 months
Measurement of articulatory speed (in syllables / seconds excluding pauses)
Time frame: From enrollment to the end of the study at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test of personality : questionnary in people with Laryngectomy and Total Pharyngo-laryngectomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille Galant (0491435817 ext. 33, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCI-defined personality traits in patients able to learn VOO and those unable to learn VOO (time frame: From enrollement to the end of the study at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.