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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT05855005
Eligibility Criteria:
Inclusion Criteria:
1. Speak English as their primary language
2. No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
3. Bilateral mild to moderate sensorineural or mixed hearing loss
4. Pass a cognitive screener
5. Minimum Grade 10 education
6. Ability to attend all study visits
7. Eligible communication partner who can attend first study visit.
Exclusion Criteria:
1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study
2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
3. Diagnosis of dementia or cognitive impairment
4. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
5. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
6. History or current fluctuating hearing loss
7. Evidence of conductive hearing loss
8. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
9. Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05855005
Study Brief:
Protocol Section:
NCT05855005