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

Oticon Medical (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire CIQoL-35

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.

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Observational Model:
Time Perspective:
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
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Evaluate the measurement properties of the French CIQoL-35. [Day 1 (one visit planned)]

    The patient is given a paper questionnaire containing the 35 items. The questionnaire indicates the following instructions: "Think about your daily life with your cochlear implant (and/or hearing aid, if you also use one). Answer how often each of the following statements applies to your feelings and experiences. Answer how often each statement applies even if you don't use cochlear implants or hearing aids."

Secondary Outcome Measures

  1. Speech performance in quiet [Day 1 (one visit planned)]

    Speech perception performance in sound field in best-aided condition (i.e., using a contralateral hearing aid if the patient does on a daily basis): Score at Lafon test (in words/phonemes) on 2 lists: 8 and 19 at 60 dB A in quiet (15 min)

  2. Speech performance in noise [Day 1 (one visit planned)]

    Score at VRB test

  3. Describe the duration of French CIQoL-35 administration [Day 1 (one visit planned)]

    Measure of duration (in minutes) to complete the CIQoL-35 done by the audiologist with a timer. The CIQoL questionnaire present 35 questions with 6 subscales with established validity; the CIQOL-35 takes 4.5 minutes to complete. For each question, the patient have 5 response options (Never (lowest score), Rarely, Sometimes, Often, Always (higher score)).

  4. Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics. [Day 1 (one visit planned)]

    Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


Site City State Country Postal Code
1 Centre de Recherche en Audiologie adulte Paris Ile De France France 75013

Sponsors and Collaborators

  • Oticon Medical


  • Principal Investigator: Isabelle MOSNIER, GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Oticon Medical
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • OM26
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023