Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT07028658
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18 or older
* Affiliated with a social security system
* Moderate to severe bilateral post-lingual hearing loss, fitted with hearing aids for more than 6 months
* Wearing hearing aids for a minimum of 8 hours/day on average over the past month
* Intelligibility in quiet \> 80% correct responses at 60 dB (Lafon cochlear list)
* Difficulty in noisy environments rated \> 6 on a 0-10 EVA scale
* French language comprehension level of at least B1 CEFR (Common European Framework of Reference for Languages)
* Willing to participate in speech therapy rehabilitation at a rate of 2 sessions per week
Exclusion Criteria:
* Patient who has already undergone speech therapy rehabilitation as part of their hearing loss treatment
* Diagnosis of neurodegenerative disease or history of brain injury (traumatic brain injury, stroke, tumor, meningitis, etc.)
* Uncorrected vision or visual impairment affecting lip reading (e.g. AMD, glaucoma, unoperated cataract, etc.)
* Presence of severe tinnitus (score \> 56) on the Tinnitus Handicap Inventory (THI) questionnaire
* Significant cognitive impairment (CODEX C or D) or Montreal Cognitive Assessment (MOCA) score \< 23
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07028658
Study Brief:
Protocol Section:
NCT07028658