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:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT04145661
Eligibility Criteria:
Inclusion Criteria:
* Aged 45 years and above.
* Bilateral moderate to severe symmetrical sensorineural hearing loss, defined as PTA thresholds from 0.5- 4kHz falling between 40dB and 85dB.
* Normal otoscopic examination and normal middle ear function.
* Currently wears bilateral hearing aids.
* Good hearing aid user \>5 hours a day bilaterally, assessed by data logging.
* English as a first language, due to the speech testing material
Exclusion Criteria:
* Under 45 years old
* Asymmetrical, mixed or conductive hearing loss,
* Recent history (\<1 year) of otalgia, otitis externa, otitis media with effusion.
* Current or recent (\<12 months ago) exposure to ototoxic medication e.g. cisplatin (or other platinum-containing chemotherapy drugs) or amikacin (or other aminoglycoside antibiotics), as stable hearing thresholds are required for the duration of the study.
* Poor hearing aid user with data logging \<5 hours a day.
* English as a foreign language, illiterate or unable to read due to poor eyesight.
* Diagnosis of conditions such as muscular dystrophies or chronic fatigue syndrome that may cause tiring during testing.
* Diagnosis of dementia or a neurological condition that would suggest poor cognitive function.
* Identification of a significant cochlear dead region (\< 3kHz) in one ear only.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
44 Years
Study:
NCT04145661
Study Brief:
Protocol Section:
NCT04145661