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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Hearing Loss; Cochlear Hearing Loss; PROM
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sarah CHOUIKH; Phone Number: +33493951818; Email: saoh@oticonmedical.com
• Study Contact Backup: Name: Michel HOEN; Phone Number: +33493951818; Email: mhoe@oticonmedical.com

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75013
      • Recruiting
      • Centre de Recherche en Audiologie adulte
      • Contact: Isabelle Mosnier, MD; Phone Number: 0142163089; Email: isabelle.mosnier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the measurement properties of the French CIQoL-35.	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."	Day 1 (one visit planned)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech performance in quiet	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)	Day 1 (one visit planned)
Speech performance in noise	Score at VRB test	Day 1 (one visit planned)
Describe the duration of French CIQoL-35 administration	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)).	Day 1 (one visit planned)
Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics.	Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics	Day 1 (one visit planned)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: OM26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No