The impact of cochlear implants on listening effort and fatigue
| ISRCTN | ISRCTN76145317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76145317 |
| Sponsor | Cochlear (France) |
| Funder | Cochlear France |
- Submission date
- 03/12/2025
- Registration date
- 31/12/2025
- Last edited
- 31/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Individuals with hearing loss have increased listening effort relative to normal hearing listeners and subsequently suffer from increased listening fatigue. Listening effort has complex aspects involving the use of mental resources to overcome obstacles to pursue listening goals, while constantly weighing whether the effort is worth the cognitive demands. With the lack of consistency across studies and widely varied measures in study populations, drawing conclusions about the impact of cochlear implant (CI) on listening effort is difficult, particularly for studies assessing the impact that listening effort has on fatigue in CI users. There are few studies investigating the impact that increased listening effort has on fatigue in CI users, with complex models of listening related fatigue not adequately captured by current measures. The use of questionnaires assessed in real world settings, including difficult listening environments, is important for understanding listening effort. This study aims to test whether subjective listening effort and general fatigue in everyday life are reduced following cochlear implantation in adults aged 18 or over with severe to profound hearing loss.
Who can participate?
Adult patients aged 18 or over with severe to profound hearing loss eligible for a CI based on French criteria and receiving their first Nucleus® CI.
What does the study involve?
Self-reported questionnaires of listening effort, general fatigue and overall benefit, reporting the everyday experiences in a home environment.
What are the possible benefits and risks of participating?
Potential benefits associated with participation in this study include helping to find better treatments and therapies and/or diagnostic tests in the area of hearing loss or related conditions and allowing a greater understanding of the obstacles faced by CI users regarding listening effort and fatigue in real world scenarios. As a non-interventional study, risks are expected to be very low. However, consideration will be given to psychological events such as anxiety or depression that may result from participation.
Where is the study run from?
-Hôpital de Hautepierre, Strasbourg, France
-Hôpital Robert Debre, Reims, France
-CHU de Dijon, Dijon, France
When is the study starting and how long is it expected to run for?
November 2025 to November 2027
Who is funding the study?
Cochlear France
Who is the main contact?
Prof. Marc Labrousse
Contact information
Public
1 University Avenue, Macquarie University
Sydney
2109
Australia
| Phone | +61 2 9428 6555 |
|---|---|
| cltd-prs-admin@cochlear.com |
Principal investigator, Scientific
Service ORL-CCF
CHU de Reims
Av du Général KOENIG
Reims
51092
France
| Phone | +33 3 26 78 70 71 |
|---|---|
| mlabrousse@chu-reims.fr |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Multi-centre observational study |
| Scientific title | The impact of cochlear implants on listening effort and fatigue: a post-market observational study |
| Study acronym | ILCI |
| Study objectives | The overall aim of the study is to evaluate whether subjective listening effort and general fatigue in everyday life are reduced following cochlear implantation in adults with severe to profound hearing loss receiving cochlear implants under standard indications. |
| Ethics approval(s) |
Approved 19/06/2025, Comité de Protection des Personnes Est III (CHRU de Nancy, Rue du Morvan, VANDOEUVRE-LES-NANCY, 54511, France; +33 3 8315 4324; cppest.3@chru-nancy.fr), ref: 2025-A00953-46 |
| Health condition(s) or problem(s) studied | Adults aged 18 or over with severe to profound hearing loss |
| Intervention | In this observational study, subjects are recruited consecutively as part of the clinical routine. Subject data will be collected pre implant and at 1- and 6-months post implant to record any changes over time in the primary outcome measures. The primary and secondary measures are self-reported questionnaires of listening effort, general fatigue, and overall benefit, reporting the everyday experiences in a home environment. Listening effort will be assessed using the Listening Effort Assessment Questionnaire (EAS). Fatigue will be assessed using the generalised Multidimensional Fatigue Inventory (MFI). Health benefits will be assessed using the Glasgow Benefit Inventory (GBI). The total period of participation for each subject will be approximately 9 months. The study will end at the 6-month routine clinical follow up appointment or at subject withdrawal. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 35 |
| Key inclusion criteria | 1. Adult patients aged 18 or over with severe to profound hearing loss eligible for a CI based on French criteria and receiving their first Nucleus CI. 2. Native French speaker. 3. Willing and able to participate in all the procedures. 4. Have no opposition to their data being collected, analysed and anonymously reported in a publication. |
| Key exclusion criteria | 1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 3. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 4. Current participation, or participation in an interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). |
| Date of first enrolment | 30/11/2025 |
| Date of final enrolment | 30/07/2027 |
Locations
Countries of recruitment
- France
Study participating centres
Strasbourg
67098
France
Reims
51092
France
Dijon
21000
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
03/12/2025: Trial's existence confirmed by Comité de Protection des Personnes Est III
