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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire CIQoL-35 | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah CHOUIKH | Contact | +33493951818 | saoh@oticonmedical.com | |
| Michel HOEN | Contact | +33493951818 | mhoe@oticonmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle MOSNIER | GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Audiologie adulte | Recruiting | Paris | Île-de-France Region | 75013 | France |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |