PEACH Questionnaire Study

Deafness Clinical Trial

— QaPEACH  

Official title:

Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125601
• Other study ID #: APHP211111
• Secondary ID: 2021-A01468-33
• Status: Completed
• Start date: December 7, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (hearing aid and / or cochlear implant).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) will be completed once.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0