Clinical trial NCT05709431: A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
Official title: A Prospective, Monocentric, Open, Non-controlled Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PROM
Cochlear Hearing Loss
Hearing Loss
Quality of Life
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2023-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients aged 18 years and older, with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months with the ability to read, understand, and indicate their answers to the 35-item French CIQoL questionnaire.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the measurement properties of the French CIQoL-35.
timeFrame: Day 1 (one visit planned)
Secondary outcomes:
measure: Speech performance in quiet
timeFrame: Day 1 (one visit planned)
measure: Speech performance in noise
timeFrame: Day 1 (one visit planned)
measure: Describe the duration of French CIQoL-35 administration
timeFrame: Day 1 (one visit planned)
measure: Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics.
timeFrame: Day 1 (one visit planned)
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Recherche en Audiologie adulte
state: Ile De France
Study officials:
affiliation: GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France
name: Isabelle MOSNIER
role: PRINCIPAL_INVESTIGATOR
References: