NCT05709431

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

A Prospective, Monocentric, Open, Non-controlled Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• PROM
• Cochlear Hearing Loss
• Hearing Loss
• Quality of Life

Interventions

Type	Name	Description
OTHER	Questionnaire CIQoL-35	The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants (1-7). 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. The CIQoL is available in two lengths: 35 questions (CIQoL-35) and 10 questions (CIQoL-10). The CIQoL-35 has interesting measurement properties including good construct validity, convergent validity, and test-retest reliability.

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-02-02
• Last updated: 2023-02-02

Locations

1 site across 1 country: France