PROMCIQoLNCT05709431
A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
An observational study of PROM and Cochlear Hearing Loss, run by Oticon Medical at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROM, Cochlear Hearing Loss, Hearing Loss
- What is being tested?
- Questionnaire CIQoL-35
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche en Audiologie adulte
Paris, Île-de-France Region, 75013
Isabelle Mosnier, MD, 0142163089, isabelle.mosnier@aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Being tested
- Questionnaire CIQoL-35
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire CIQoL-35Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Day 1 (one visit planned)
Secondary outcomes (4)
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)
Measured: Day 1 (one visit planned)
Speech performance in noise
Score at VRB test
Measured: 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)).
Measured: 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
Measured: Day 1 (one visit planned)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start12 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle MOSNIER, Principal investigator, GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709431
- Sponsor's protocol ID
- OM26
- Acronym
- CIQoL
- Status last verified
- Jan 2023
- First submitted
- 12 Oct 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05709431
- Acronym / sponsor ID
- CIQoL / OM26
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire CIQoL-35The 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. | Other | – |
Primary outcome
Evaluate the measurement properties of the French CIQoL-35.
Time frame: 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."
4 secondary outcomes
Speech performance in quiet
Time frame: Day 1 (one visit planned)
Speech performance in noise
Time frame: Day 1 (one visit planned)
Describe the duration of French CIQoL-35 administration
Time frame: Day 1 (one visit planned)
Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics.
Time frame: Day 1 (one visit planned)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle MOSNIER principal investigator
GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PROM and Cochlear Hearing Loss, run by Oticon Medical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah CHOUIKH (+33493951818, saoh@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the measurement properties of the French CIQoL-35. (time frame: Day 1 (one visit planned)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.