A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.

Oticon Medical

Status: Enrolling

Conditions: Quality of Life; Hearing Loss; PROM; Cochlear Hearing Loss

Treatments: Other: Questionnaire CIQoL-35

Study type: Observational

Funder types: Industry

Identifiers

NCT05709431

OM26

Details and patient eligibility

About

The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants. The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

Full description

The CIQoL-35 has been translated and adapted from English to French in accordance with the guidelines of Hall and colleagues.

The purpose of the current study is to describe the measurement properties of the French CIQoL-35 questionnaire.

Hall et al recommend that at least 8 patients participate in any qualitative testing of the translation (n=13 in the previous study) and that at least 50 patients participate in a measurement property evaluation (n=50 in the present study).

The aim of this study is not to assess the performance of the device or compare the performance of different devices/brands but to correlate quality of life scores with speech understanding in patients with cochlear implants. The main objective of the study is to validate the translation of the questionnaire, the correlation is a secondary criterion.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥ 18 years) user of at least one cochlear implant system,
• Duration of cochlear experience ≥ 6 months (period from cochlear implant activation to study enrolment),
• Psychological/literacy ability to read, understand, and complete the questionnaire.

Exclusion criteria

• Patient who participated in initial validation of the French CIQoL-35 (CIQoL project part 1),
• Patient with a psychological or linguistic inability to understand the information sheet or the questionnaire,
• Patient under legal protection or deprived of liberty,
• Unwillingness or inability to comply with all investigational requirements.