Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05917496
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Clara LEGENDRE, speech therapist
Phone 1 71 39 67 96
Email clara.legendre@aphp.fr
Status Not yet recruiting
Phase
Start date July 2024
Completion date May 2026

See also
  Status Clinical Trial Phase
Recruiting NCT01940783 - Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation N/A
Completed NCT04832373 - Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2 N/A
Recruiting NCT04906135 - Auditory Neural Function in Implanted Patients With Usher Syndrome N/A
Recruiting NCT06040892 - Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children N/A
Completed NCT02902497 - Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation N/A
Not yet recruiting NCT06375278 - Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation N/A
Completed NCT03256097 - Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System N/A
Active, not recruiting NCT02830659 - Cochlear Implants Registry in Thailand Project N/A
Active, not recruiting NCT04192968 - Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Recruiting NCT05547113 - Vestibular Function in Cochlear Implant Patients
Not yet recruiting NCT05122364 - Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital N/A
Completed NCT03958006 - Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma N/A
Completed NCT03950375 - Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation