DeafnessQaPEACHNCT05125601
PEACH Questionnaire Study
An observational study of Deafness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids. The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Deafness
- What is being tested?
- The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
- Type of treatment
- Pill or oral medicine
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2021to 30 Jun 2022
- 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 2 to 10 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 2 to 10 years (inclusive)
- Patients followed in consultation at Necker Hospital in the Pediatric ENT department
- With a slight to deep bilateral deafness
- Auditory experience with hearing aid and / or cochlear implant bilateral for more than 1 month
- holders of parental authority not opposed to participation in the study
Who cannot join
- Non-wearing of hearing aid and / or implant over the last month
- malfunction of hearing aids and / or implant
- Non-understanding of the French language by parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.
The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).
Read the detailed description
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.
The study will allow an evaluation of the quality of life benefit of hearing rehabilitation at different ages and with varying levels of deafness.
The translated questionnaire for the study will be given to the parents of the child after a sure diagnosis of the child's degree of deafness and at least 1 month of hearing aids. The translated is proposed by Necker Hospital Pediatric ENT department.
The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).
- Conditions
- Deafness
- Being tested
- The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
- Keywords
- Deafness in children, The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) in french
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)Other
Also called Questionnaire
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) will be completed once.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bilateral deafness | Patients aged 2 to 10 years with bilateral deafness, wearing an amplifier device and / or a cochlear implant. Receives: Other: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing quality of life
Score at the Peach questionnaire: qualitative assessment of the perception with the equipment in various modalities of everyday life.
The Peach questionnaire is composed of 13 questions with the possibility of setting a score between 0 (never) and 4 (always). Each questionnaire gives an average of the embarrassment of the children in the silence and in the noise. The results will give the opportunity to change the settings, evaluate the quality of the hearing aid and the change them if it is necessary.
Measured: Day 0
Secondary outcomes (2)
Difference of score to the Peach questionnaire according to the type of hearing aids
Difference of scores according to the hearing aid:
- Bilateral hearing aid,
- Bilateral cochlear implant,
- A cochlear implant on one side and an auditory device on the other. The Peach questionnaire is composed of 13 questions with the possibility of setting a score between 0 (never) and 4 (always). Each questionnaire gives an average of the embarrassment of the children in the silence and in the noise. The results will give the opportunity to change the settings, evaluate the quality of the hearing aid and the change them if it is necessary.
Measured: Day 0
Difference of score to the Peach questionnaire according to the type of deafness
Difference of scores according to the degree of deafness as well as the origin of deafness: congenital non-evolutive, evolutive.
The Peach questionnaire is composed of 13 questions with the possibility of setting a score between 0 (never) and 4 (always). Each questionnaire gives an average of the embarrassment of the children in the silence and in the noise. The results will give the opportunity to change the settings, evaluate the quality of the hearing aid and the change them if it is necessary.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start7 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 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
- Natalie LOUNDON, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisTabatha DERAY, Hearing Care Professional, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125601
- Sponsor's protocol ID
- APHP211111
- Other IDs
- 2021-A01468-33
- Acronym
- QaPEACH
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire
- ClinicalTrials.gov ID
- NCT05125601
- Acronym / sponsor ID
- QaPEACH / APHP211111
- Conditions
- Deafness
- Keywords
- Deafness in children, The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) in french
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Nov 2021 (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.
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.
The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).
Detailed description
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.
The study will allow an evaluation of the quality of life benefit of hearing rehabilitation at different ages and with varying levels of deafness.
The translated questionnaire for the study will be given to the parents of the child after a sure diagnosis of the child's degree of deafness and at least 1 month of hearing aids. The translated is proposed by Necker Hospital Pediatric ENT department.
The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bilateral deafness | – | Other: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)Patients aged 2 to 10 years with bilateral deafness, wearing an amplifier device and / or a cochlear implant. |
Who may qualify
- Ages
- 2 to 10 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 (5 listed)
- Minors aged 2 to 10 years (inclusive)
- Patients followed in consultation at Necker Hospital in the Pediatric ENT department
- With a slight to deep bilateral deafness
- Auditory experience with hearing aid and / or cochlear implant bilateral for more than 1 month
- holders of parental authority not opposed to participation in the study
Key exclusion criteria (3 listed)
- Non-wearing of hearing aid and / or implant over the last month
- malfunction of hearing aids and / or implant
- Non-understanding of the French language by parents
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 |
|---|---|---|
| The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)Also: QuestionnaireThe Parents' Evaluation of Aural/Oral Performance of Children (PEACH) will be completed once. | Other | Patients with bilateral deafness |
Primary outcome
Hearing quality of life
Time frame: Day 0
Score at the Peach questionnaire: qualitative assessment of the perception with the equipment in various modalities of everyday life. The Peach questionnaire is composed of 13 questions with the possibility of setting a score between 0 (never) and 4 (always). Each questionnaire gives an average of the embarrassment of the children in the silence and in the noise. The results will give the opportunity to change the settings, evaluate the quality of the hearing aid and the change them if it is necessary.
2 secondary outcomes
Difference of score to the Peach questionnaire according to the type of hearing aids
Time frame: Day 0
Difference of score to the Peach questionnaire according to the type of deafness
Time frame: Day 0
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 12 Sep 2025.
- 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.
Natalie LOUNDON, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Tabatha DERAY, Hearing Care Professional study director
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 5 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 12 Sep 2025. 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?
Hearing quality of life (time frame: Day 0). 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 12 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.