Clinical Trials Directory

Trials / Completed

CompletedNCT06108609

Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Estimating patient satisfaction is essential in modern day-to-day medical practice. This is particularly true in the field of audiology where evaluating the benefit of patients' devices makes it possible to improve settings and increase patient satisfaction and therefore compliance. Questionnaires measuring hearing aid benefit such as the IOI-HA (International Outcome Inventory for Hearing Aids) and the COSI (Client Oriented Scale of Improvement) are used in everyday practice and promote cooperation between researchers by providing comparable data. Unlike other countries, these questionnaires have never been validated in French by psychometric studies. The objective of this study is to validate the translation of the IOI-HA questionnaire already used in the clinic and to adapt the COSI into French and statistically validate its translation.

Detailed description

Recruitment of cases via the otological consultation of the ENT department, among patients consulting for hearing aids. Inclusion will be suspended once 100 tests and at least 35 re-tests have been completed. Inclusion (D0): * Audiometry (as part of treatment) * Clinical evaluation (as part of treatment) * Passing the French version of the COSI and IOI-HA questionnaires Visit 1 (D0 +3±1 week): only for 35 patients Second administration of the French version of the COSI and IOI-HA questionnaires either by telephone, or during a second consultation or hospitalization, if this occurs within a compatible time frame.

Conditions

Interventions

TypeNameDescription
OTHERAdministration of the French version of the COSI and IOI-HA questionnairesInclusion (D0): * Audiometry (as part of treatment) * Clinical evaluation (as part of treatment) * Passing the French version of the COSI and IOI-HA questionnaires Visit 1 (D0 +3±1 week): only for 35 patients Second administration of the French version of the COSI and IOI-HA questionnaires either by telephone, or during a second consultation or hospitalization, if this occurs within a compatible time frame.

Timeline

Start date
2023-05-16
Primary completion
2024-08-08
Completion
2024-08-08
First posted
2023-10-31
Last updated
2025-12-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06108609. Inclusion in this directory is not an endorsement.