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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04106063
Other study ID # 69HCL19_0533
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date November 23, 2020

Study information

Verified date December 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Deafness significantly affects several auditory tasks of everyday life in children: understanding speech in quiet and noisy environments, spatial location of sounds ... These difficulties in locating sound sources are often ignored by parents and underestimated by children. Nowadays we there is specific tools to evaluate these problems in children. Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for adults that evaluates auditory abilities, including sound localization, in different tasks of daily life. Although robust, this questionnaire includes 49 questions and is too long for daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of the SSQ questionnaire for adults with only 15 items. Based on this model, the aim of this study is to develop and test a paediatric questionnaire with 12 items to assess more specifically auditory difficulties in deaf children. This questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of hearing (4 items). These 3 subscales are identical to those defined in long and short form pf the adult SSQ questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date November 23, 2020
Est. primary completion date November 23, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria: - Male or female aged 7-17 (inclusive) - Attending medical appointment for temporary or persistent deafness - Able to understand the experimental instructions Exclusion Criteria: none-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
KID SSQ12 questionnaire
During a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties

Locations

Country Name City State
France ENT departement, Edouard Herriot Hospital Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary KID SSQ12 questionnaire score This questionnaire evaluates auditive abilities (including sound localisation) in different every day life tasks, in deaf children. It is made up of 12 items ; for each item the score range is between 0 (worse outcome) and 10 (best outcome). The questionnaire is devided into 3 subscores of 4 items : speech audition, spatial audition and quality of audition.
Thanks to that tool, internal structures (internal consistency, sub-scale structure obtained by principal component analysis and cluster analysis) and psychometric values will be compared with adult versions of the questionnaire (complete and abbreviated) published in the international literature. Overall scores, scores by subscales and items will be compared.
At inclusion
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