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

Quality of Life Clinical Trial

— CIQoL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709431
• Other study ID #: OM26
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Oticon Medical
• Contact: Sarah CHOUIKH
• Phone: +33493951818
• Email: saoh[@]oticonmedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• PROM
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
France	Centre de Recherche en Audiologie adulte	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Speech performance in noise	Score at VRB test	Day 1 (one visit planned)
Secondary	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)
Secondary	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)