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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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PROM Cochlear Hearing Loss Hearing Loss Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No