NCT04106063

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

September 25, 2019

Last Update Submit

December 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Other: KID SSQ12 questionnaire

Interventions

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

deaf children

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our ENT department

You may qualify if:

  • Male or female aged 7-17 (inclusive)
  • Attending medical appointment for temporary or persistent deafness
  • Able to understand the experimental instructions

You may not qualify if:

  • none-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT departement, Edouard Herriot Hospital

Lyon, 69003, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric TRUY, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

November 20, 2019

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

December 17, 2021

Record last verified: 2021-12

Locations