NCT05125601

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

December 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

November 8, 2021

Last Update Submit

September 5, 2025

Conditions

Keywords

Deafness in childrenThe Parents' Evaluation of Aural/Oral Performance of Children (PEACH) in french

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference of score to the Peach questionnaire according to the type of hearing aids

    Day 0

  • Difference of score to the Peach questionnaire according to the type of deafness

    Day 0

Study Arms (1)

Patients with bilateral deafness

Patients aged 2 to 10 years with bilateral deafness, wearing an amplifier device and / or a cochlear implant.

Other: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)

Interventions

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

Also known as: Questionnaire
Patients with bilateral deafness

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Deafness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Natalie LOUNDON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Tabatha DERAY, Hearing Care Professional

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

December 7, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations