- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106063
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children (KID SSQ12)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69003
- ENT departement, Edouard Herriot Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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deaf children
All Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our Ear, Nose and Throat (ENT) department
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During a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KID SSQ12 questionnaire score
Time Frame: At inclusion
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric TRUY, MD, PhD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0533
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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