- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125601
PEACH Questionnaire Study (QaPEACH)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75015
- Hôpital Necker-Enfants Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with bilateral deafness
Patients aged 2 to 10 years with bilateral deafness, wearing an amplifier device and / or a cochlear implant.
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The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) will be completed once.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference of score to the Peach questionnaire according to the type of hearing aids
Time Frame: Day 0
|
Difference of scores according to the hearing aid:
|
Day 0
|
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Difference of score to the Peach questionnaire according to the type of deafness
Time Frame: Day 0
|
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. |
Day 0
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Tabatha DERAY, Hearing Care Professional, Assistance Publique - Hôpitaux de Paris
- Principal Investigator: Natalie Loundon, MD, PhD, Assistance Publique - Hôpitaux de Paris
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Otorhinolaryngologic Diseases
- Sensation Disorders
- Ear Diseases
- Hearing Loss
- Hearing Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Deafness
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- APHP211111
- 2021-A01468-33 (Other Identifier: ID RCB number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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