DeafnessSSQ-PEACHNCT04563884
Validity of the French Version of Deafness Questionnaires for Children and Adolescents
An observational study of Deafness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone. Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Deafness
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2020to 31 Dec 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.
Who may be able to join
- Minors aged 12 months to 17 years (inclusive)
- Patients followed in consultation at Necker Hospital in the Pediatric ENT department
- holders of parental authority not opposed to participation in the study
- Patients :
- Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral
- Perceptual or transmission deafness or mixed
Show all 10Show fewer
- Controls:
- Patients not presenting a hearing disorder at the time of inclusion or in his or her history
- Examination of the normal eardrums
- No history of ear surgery
Who cannot join
- Psychomotor retardation
- Abnormal neurological examination
- Mother tongue of the child and parents other than French
Trial locations and contacts
1 site in 1 country.
About this study
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Read more
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.
The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.
Read the detailed description
Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.
Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) is a hetero-evaluation score used to study the quality of a child's communication from an early age (from 4 months in some studies) and up to 13 years. This tool is specifically designed for children with hearing aids or a cochlear implant. It has been translated into Swedish and Spanish and used in numerous international publications.
The Speech, Spatial and Qualities of Hearing Scale (SSQ) is an adult self-assessment score assessing, in three categories, the performance of speech comprehension, spatial hearing and hearing quality. It is widely used internationally in its adult version.
This adult score has been adapted and used for the pediatric population in a hetero-evaluation score by parents (SSQ-P) from 5 years old, and a simplified score (SSQ-C) usable by children> 11 years.
In addition, the authors of the adult SSQ also prepared and validated a Handicap questionnaire to target the impact of hearing loss on quality of life, and integrated into the SSQ self-assessment.
The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.
The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.
- Conditions
- Deafness
- Being tested
- Questionnaires
- Keywords
- Deafness, Children, SSQ questionnaire, PEACH questionnaire
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)
Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also).
Questionnaires will be completed twice, 15 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Patients with deafness | Patients aged 12 months to 17 years with deafness Receives: Other: Questionnaires | |
| Controls | Normal-hearing patients aged 12 months to 17 years Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired student t-test
Reproducibility of the questionnaire completed by a subject at 15 days apart
Measured: 1 year
Cronbach alpha test
Internal consistency
Measured: 1 year
Item-total Pearson correlation
Measure of reliability
Measured: 1 year
Principal components analysis
Measure of efficiency
Measured: 1 year
Receiver Operating Characteristic (ROC) curve
Limit value of normality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start4 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Françoise Denoyelle, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563884
- Sponsor's protocol ID
- APHP200794
- Other IDs
- 2020-A01274-35
- Acronym
- SSQ-PEACH
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gargula S, Simon F, Celerier C, Couloigner V, Leboulanger N, Loundon N, Denoyelle F. French adaptation and validation of parents' evaluation of aural/oral performance of children (PEACH) scale in children. Int J Audiol. 2023 Jun;62(6):592-598. doi: 10.1080/14992027.2022.2059714. Epub 2022 May 9.
PubMed 35533092
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the French Version of Deafness Questionnaires for Children and Adolescents
- ClinicalTrials.gov ID
- NCT04563884
- Acronym / sponsor ID
- SSQ-PEACH / APHP200794
- Conditions
- Deafness
- Keywords
- Deafness, Children, SSQ questionnaire, PEACH questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Sep 2020 (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.
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.
The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.
Detailed description
Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.
Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) is a hetero-evaluation score used to study the quality of a child's communication from an early age (from 4 months in some studies) and up to 13 years. This tool is specifically designed for children with hearing aids or a cochlear implant. It has been translated into Swedish and Spanish and used in numerous international publications.
The Speech, Spatial and Qualities of Hearing Scale (SSQ) is an adult self-assessment score assessing, in three categories, the performance of speech comprehension, spatial hearing and hearing quality. It is widely used internationally in its adult version.
This adult score has been adapted and used for the pediatric population in a hetero-evaluation score by parents (SSQ-P) from 5 years old, and a simplified score (SSQ-C) usable by children> 11 years.
In addition, the authors of the adult SSQ also prepared and validated a Handicap questionnaire to target the impact of hearing loss on quality of life, and integrated into the SSQ self-assessment.
The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.
The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with deafness | – | Other: QuestionnairesPatients aged 12 months to 17 years with deafness |
| Controls | – | Other: QuestionnairesNormal-hearing patients aged 12 months to 17 years |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.
Key inclusion criteria (10 listed)
- Minors aged 12 months to 17 years (inclusive)
- Patients followed in consultation at Necker Hospital in the Pediatric ENT department
- holders of parental authority not opposed to participation in the study
- Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral
- Perceptual or transmission deafness or mixed
Key exclusion criteria (3 listed)
- Psychomotor retardation
- Abnormal neurological examination
- Mother tongue of the child and parents other than French
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 |
|---|---|---|
| QuestionnairesAlso: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also). Questionnaires will be completed twice, 15 days apart. | Other | Controls, Patients with deafness |
Primary outcome
Paired student t-test
Time frame: 1 year
Reproducibility of the questionnaire completed by a subject at 15 days apart
Cronbach alpha test
Time frame: 1 year
Internal consistency
Item-total Pearson correlation
Time frame: 1 year
Measure of reliability
Principal components analysis
Time frame: 1 year
Measure of efficiency
Receiver Operating Characteristic (ROC) curve
Time frame: 1 year
Limit value of normality
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 11 Mar 2026.
- Results publication: PubMed 35533092Gargula S, Simon F, Celerier C, Couloigner V, Leboulanger N, Loundon N, Denoyelle F. French adaptation and validation of parents' evaluation of aural/oral performance of children (PEACH) scale in children. Int J Audiol. 2023 Jun;62(6):592-598. doi: 10.1080/14992027.2022.2059714. Epub 2022 May 9.
- Individual participant dataSharing planned: No
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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.
Françoise Denoyelle, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 3 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 11 Mar 2026. 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?
Paired student t-test (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563884, which also lists 1 linked publication.
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 11 Mar 2026.