Profound Congenital DeafnessACLEICNCT05917496
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
An observational study of Profound Congenital Deafness and Cochlear Implantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. Read more about this study
- Who is it for?
- Ages 11 to 21 months
- Conditions the study is for
- Profound Congenital Deafness, Cochlear Implantation
- What is being tested?
- LENA tool: Language ENvironment Analysis and Return of the analysis of the data of LENA
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2024to Jul 2026
- Phase
- Observational
- 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 11 to 21 months
- All sexes
- No healthy volunteers
- Child
Study population: Children under 24 months with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Hôpital Necker-Enfants Maladies and who receive a speech therapy.
Who may be able to join
- Have profound congenital deafness
- Have been implanted between 8 months and 18 months
- Have had a unilateral or bilateral cochlear implant for 3 months
- Be between 11 months and 21 months old on the day of inclusion
- Constant wearing of the implant
- Benefit from speech therapy
- Have a French-speaking parent
- Information and non-opposition of holders of parental authority to participate in the study
Who cannot join
- Syndromic deafness or auditory nerve aplasia
- Micro-cochlea or partial insertion of the electrode bundle
- CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies/deafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and/or mental retardation, genital hypoplasia, ear abnormalities/deafness)
- Deafness with significant central involvement (cytomegalovirus, meningitis)
- Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)
- Non-daily wearing of the cochlear implant
- Proven uncorrected visual disturbances interfering with the performance of language level assessment tests
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
Hôpital Necker-Enfants Malades
Paris, 75015
Clara LEGENDRE, speech therapist, 1 71 39 67 96 ext. +33, clara.legendre@aphp.fr
Marine PARODI, MD
About this study
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
Read the detailed description
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in daily environment. On the basis of this quantitative data provided by the LENA, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
The LENA tool was validated in French version in 2015. It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours, with a minimum of 10 consecutive hours. For the study, the families make 2 separate recordings of 6 months at home (T1 and T2) then, a centralized analysis of all the data is carried out by the speech therapist using adapted software, the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family after T1 and after T2.
The parameters resulting from this analysis relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". Average numerical scores expressed in percentiles are published at the end of the analysis. Individual scores are then compared to a standard expressed as percentiles. The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis.
- Being tested
- LENA tool: Language ENvironment Analysis, Return of the analysis of the data of LENA
- Keywords
- Profound congenital deafness, Early cochlear implantation, Language environment, Child's language development, Speech therapy assessment, Language ENvironment Analysis (LENA) tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA tool: Language ENvironment AnalysisOther
Recording of the language environment of the child at home, in daily environment, with the LENA.
The parameters recorded relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media".
The LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2.
Return of the analysis of the data of LENABehavioural
The analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Children aged 11 months to 21 months on the day of inclusion in the study, with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Necker-Enfants Malades hospital and who receive a speech therapy. Receives: Other: LENA tool: Language ENvironment Analysis; Behavioral: Return of the analysis of the data of LENA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of conversation turns
Comparison of the variation in language environment for the number of conversation turns recorded at T1 and the number of conversation turns recorded at T2 after speech therapy support offered at T1 and based on data provided by the Language ENvironment Analysis (LENA) tool.
Average numerical scores expressed in percentiles are produced at the end of the analysis. The individual scores are then compared with a standard expressed in percentiles.
Measured: 6 months
Receptive lexical level
Receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2.
Each child's individual result is given in percentiles according to chronological age. It is based on an evaluation sheet with benchmarks in percentiles (10th to 90th) or percentages.
Measured: 6 months
Correlation between the number of conversation turns parameter and the receptive lexical level
The correlation between the "conversation turns" parameter recorded at T1 and T2 and the receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2 will be carried out.
Measured: 6 months
Secondary outcomes (4)
Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level
To study the link between the 3 others language environment parameters (adult words, child vocalization, exposure to electronic media), evaluated by the LENA system and the receptive lexical level, measured by the standardized speech therapy test carried out at T1 and T2.
Average numerical scores expressed in percentiles are produced at the end of the analysis. The individual scores are then compared with a standard expressed in percentiles.
Measured: 6 months
Acceptability of the use of the LENA tool for children under 3 years
Evaluate the acceptability of the use of the LENA tool for children under 3 years old implanted between 8 and 18 months using the acceptability questionnaire completed by the parents concerning the use of the LENA system in their child at T1 and T2.
An "acceptability" score will be calculated on the basis of this questionnaire and expressed as a percentage: the questionnaire consists of 6 questions, each answer worth 2, 1 or 0 points (i.e. a maximum gross score of 12 points), then the gross score divided by 6 and multiplied by 50 to obtain a percentage score (100% corresponding to excellent acceptability).
Measured: 24 months
Protocolizing the individual strategies given to help and support parents to enrich their child's language environment
Analyze the individual results obtained from the language environment data collected from the LENA tool, in order to provide personalized advice to parents after T1 and T2, with the aim of improving their child's language environment. Comparison of individual scores at T1 and T2 for the 4 parameters evaluated by the LENA system ("adult words", "conversation turns", "child vocalizations" and "exposure to electronic media") with the means scores obtained. Carry out a process of protocolizing the individual strategies given to help and support parents in enriching their child's language environment.
Measured: 6 months
Family participation during speech therapy
Comparison of scores from the family participation scale at T1 and T2. The speech and language therapist subjectively assesses the family's involvement by assigning a number corresponding to the level of involvement and motivation: the calibration is made from 1 (limited involvement) to 5 (ideal involvement).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start13 Sep 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Profound Congenital DeafnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Clara LEGENDRE, speech therapist, Principal investigator, Assistance Publique - Hôpitaux de ParisNatalie LOUNDON, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917496
- Sponsor's protocol ID
- APHP230423
- Other IDs
- 2023-A00405-40
- Acronym
- ACLEIC
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ambrose SE, VanDam M, Moeller MP. Linguistic input, electronic media, and communication outcomes of toddlers with hearing loss. Ear Hear. 2014 Mar-Apr;35(2):139-47. doi: 10.1097/AUD.0b013e3182a76768.
PubMed 24441740Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
PubMed 26174716Canault, M., Le Normand, M.-T., & Thai Van, H. (2017). LENATM (Language ENvironment Analysis System) : Un système de reconnaissance automatique de la parole et de l'environnement langagier de l'enfant. Enfance, 2(2), 199 216. https://doi.org/10.3917/enf1.172.0199
Coquet, F., Roustit, J. (2009).Batterie EVALO 2-6 : un nouvel outil d'EVAluation du développement du Langage Oral chez l'enfant de 2 ans 3 mois à 6 ans 3 mois. UPLF Infos, janvier. Union Professionnelle des Logopèdes Francophones. Belgique
Dunn LM., Theriault-Whalen CM., Dunn LM. (1993). Echelle de Vocabulaire en Images Peabody. (EVIP). Toronto (Canada) : Psychan.
Gilkerson J. & Richards J. A. (2009) The power of talk: Impact of adult talk, conversational turns, and TV during the critical 0-4 years of child development (Technical Report LTR-01-2). Retrieved from: http://www.lenababy.com/pdf/The_Power_of_Talk.pdf
Fenson L., Dale P., Reznick S., Thal D., Bates E., Hartung J., Tethick S., Reilly J. : MacArthur Communicative Development Inventories : User's guide and technical manual, San Diego, CA, Singular Publishing Group, 1993.
Hart B. & Risley T. (1995). Meaningful differences in the everyday experience of young American children. Baltimore: Brookes.
Haute Autorité de Santé. (2009, décembre). Recommandations de bonne pratique : surdité de l'enfant : accompagnement des familles et suivi de l'enfant de 0 à 6 ans, hors accompagnement scolaire. HYPE://www.has-sante.fr/jcms/c_922867/fr/surdite-de-l-enfant-accompagnement-des- familles-et-suivi-de-l-enfant-de-0-a-6-ans-hors-accompagnement-scolaire
Moeller MP. Early intervention and language development in children who are deaf and hard of hearing. Pediatrics. 2000 Sep;106(3):E43. doi: 10.1542/peds.106.3.e43.
PubMed 10969127Moeller MP, Carr G, Seaver L, Stredler-Brown A, Holzinger D. Best practices in family-centered early intervention for children who are deaf or hard of hearing: an international consensus statement. J Deaf Stud Deaf Educ. 2013 Oct;18(4):429-45. doi: 10.1093/deafed/ent034.
PubMed 24030911Kern, S. & Gayraud, G., 2010,
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05917496
- Acronym / sponsor ID
- ACLEIC / APHP230423
- Keywords
- Profound congenital deafness, Early cochlear implantation, Language environment, Child's language development, Speech therapy assessment, Language ENvironment Analysis (LENA) tool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Jun 2023 (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.
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
Detailed description
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in daily environment. On the basis of this quantitative data provided by the LENA, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
The LENA tool was validated in French version in 2015. It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours, with a minimum of 10 consecutive hours. For the study, the families make 2 separate recordings of 6 months at home (T1 and T2) then, a centralized analysis of all the data is carried out by the speech therapist using adapted software, the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family after T1 and after T2.
The parameters resulting from this analysis relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". Average numerical scores expressed in percentiles are published at the end of the analysis. Individual scores are then compared to a standard expressed as percentiles. The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: LENA tool: Language ENvironment Analysis, Behavioral: Return of the analysis of the data of LENAChildren aged 11 months to 21 months on the day of inclusion in the study, with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Necker-Enfants Malades hospital and who receive a speech therapy. |
Who may qualify
- Ages
- 11 to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 24 months with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Hôpital Necker-Enfants Maladies and who receive a speech therapy.
Key inclusion criteria (8 listed)
- Have profound congenital deafness
- Have been implanted between 8 months and 18 months
- Have had a unilateral or bilateral cochlear implant for 3 months
- Be between 11 months and 21 months old on the day of inclusion
- Constant wearing of the implant
Key exclusion criteria (7 listed)
- Syndromic deafness or auditory nerve aplasia
- Micro-cochlea or partial insertion of the electrode bundle
- CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies/deafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and/or mental retardation, genital hypoplasia, ear abnormalities/deafness)
- Deafness with significant central involvement (cytomegalovirus, meningitis)
- Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)
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 |
|---|---|---|
| LENA tool: Language ENvironment AnalysisRecording of the language environment of the child at home, in daily environment, with the LENA. The parameters recorded relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". The LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2. | Other | Patients |
| Return of the analysis of the data of LENAThe analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills. | Behavioural | Patients |
Primary outcome
Number of conversation turns
Time frame: 6 months
Comparison of the variation in language environment for the number of conversation turns recorded at T1 and the number of conversation turns recorded at T2 after speech therapy support offered at T1 and based on data provided by the Language ENvironment Analysis (LENA) tool. Average numerical scores expressed in percentiles are produced at the end of the analysis. The individual scores are then compared with a standard expressed in percentiles.
Receptive lexical level
Time frame: 6 months
Receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2. Each child's individual result is given in percentiles according to chronological age. It is based on an evaluation sheet with benchmarks in percentiles (10th to 90th) or percentages.
Correlation between the number of conversation turns parameter and the receptive lexical level
Time frame: 6 months
The correlation between the "conversation turns" parameter recorded at T1 and T2 and the receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2 will be carried out.
4 secondary outcomes
Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level
Time frame: 6 months
Acceptability of the use of the LENA tool for children under 3 years
Time frame: 24 months
Protocolizing the individual strategies given to help and support parents to enrich their child's language environment
Time frame: 6 months
Family participation during speech therapy
Time frame: 6 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 12 Sep 2025.
- Background: PubMed 24441740Ambrose SE, VanDam M, Moeller MP. Linguistic input, electronic media, and communication outcomes of toddlers with hearing loss. Ear Hear. 2014 Mar-Apr;35(2):139-47. doi: 10.1097/AUD.0b013e3182a76768.
- Background: PubMed 26174716Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
- BackgroundCanault, M., Le Normand, M.-T., & Thai Van, H. (2017). LENATM (Language ENvironment Analysis System) : Un système de reconnaissance automatique de la parole et de l'environnement langagier de l'enfant. Enfance, 2(2), 199 216. https://doi.org/10.3917/enf1.172.0199
- BackgroundCoquet, F., Roustit, J. (2009).Batterie EVALO 2-6 : un nouvel outil d'EVAluation du développement du Langage Oral chez l'enfant de 2 ans 3 mois à 6 ans 3 mois. UPLF Infos, janvier. Union Professionnelle des Logopèdes Francophones. Belgique
- BackgroundDunn LM., Theriault-Whalen CM., Dunn LM. (1993). Echelle de Vocabulaire en Images Peabody. (EVIP). Toronto (Canada) : Psychan.
- BackgroundGilkerson J. & Richards J. A. (2009) The power of talk: Impact of adult talk, conversational turns, and TV during the critical 0-4 years of child development (Technical Report LTR-01-2). Retrieved from: http://www.lenababy.com/pdf/The_Power_of_Talk.pdf
- BackgroundFenson L., Dale P., Reznick S., Thal D., Bates E., Hartung J., Tethick S., Reilly J. : MacArthur Communicative Development Inventories : User's guide and technical manual, San Diego, CA, Singular Publishing Group, 1993.
- BackgroundHart B. & Risley T. (1995). Meaningful differences in the everyday experience of young American children. Baltimore: Brookes.
- BackgroundHaute Autorité de Santé. (2009, décembre). Recommandations de bonne pratique : surdité de l'enfant : accompagnement des familles et suivi de l'enfant de 0 à 6 ans, hors accompagnement scolaire. HYPE://www.has-sante.fr/jcms/c_922867/fr/surdite-de-l-enfant-accompagnement-des- familles-et-suivi-de-l-enfant-de-0-a-6-ans-hors-accompagnement-scolaire
- Background: PubMed 10969127Moeller MP. Early intervention and language development in children who are deaf and hard of hearing. Pediatrics. 2000 Sep;106(3):E43. doi: 10.1542/peds.106.3.e43.
- Background: PubMed 24030911Moeller MP, Carr G, Seaver L, Stredler-Brown A, Holzinger D. Best practices in family-centered early intervention for children who are deaf or hard of hearing: an international consensus statement. J Deaf Stud Deaf Educ. 2013 Oct;18(4):429-45. doi: 10.1093/deafed/ent034.
- BackgroundKern, S. & Gayraud, G., 2010,
- Individual participant dataSharing planned: No
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.
Clara LEGENDRE, speech therapist principal investigator
Assistance Publique - Hôpitaux de Paris
Natalie LOUNDON, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Profound Congenital Deafness and Cochlear Implantation, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 7 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 12 Sep 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 Clara LEGENDRE, speech therapist (1 71 39 67 96 ext. +33, clara.legendre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of conversation turns (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917496, which also lists 12 linked publications.
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 12 Sep 2025.