DeafnessKID SSQ12NCT04106063
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
An observational study of Deafness and Pediatric, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- What is being tested?
- KID SSQ12 questionnaire
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2019to 23 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our ENT department
Who may be able to join
- Male or female aged 7-17 (inclusive)
- Attending medical appointment for temporary or persistent deafness
- Able to understand the experimental instructions
Who cannot join
- none-
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- KID SSQ12 questionnaire
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KID SSQ12 questionnaireOther
During a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: KID SSQ12 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start20 Nov 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric TRUY, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106063
- Sponsor's protocol ID
- 69HCL19_0533
- Acronym
- KID SSQ12
- Status last verified
- Dec 2021
- First submitted
- 25 Sep 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
- ClinicalTrials.gov ID
- NCT04106063
- Acronym / sponsor ID
- KID SSQ12 / 69HCL19_0533
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 26 Sep 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deaf children | – | Other: KID SSQ12 questionnaireAll Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our Ear, Nose and Throat (ENT) department |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All Children between 7 and 17 years old attending medical appointment for temporary or persistent deafness in our ENT department
Key inclusion criteria (3 listed)
- Male or female aged 7-17 (inclusive)
- Attending medical appointment for temporary or persistent deafness
- Able to understand the experimental instructions
Key exclusion criteria (1 listed)
- none-
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 |
|---|---|---|
| KID SSQ12 questionnaireDuring a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties | Other | deaf children |
Primary outcome
KID SSQ12 questionnaire score
Time frame: At inclusion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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. This study is not recruiting at the moment.
Eric TRUY, MD, PhD principal investigator
Hospices Civils de Lyon
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 Deafness and Pediatric, run by Hospices Civils de Lyon 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KID SSQ12 questionnaire score (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.