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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT04240561
Eligibility Criteria:
Inclusion Criteria:
1. Speak English as their primary language
2. Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart)
3. Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear
4. Clinical Dementia Rating (CDR) of 0.5 or 1 (indicating slight or mild cognitive impairment in the areas of memory, orientation, judgment/problem solving, community affairs, behavior at home/hobbies, and personal care)
5. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18).
6. Living at home
7. Minimum Grade 10 education
8. Able to provide own consent as evaluated by the Consent Assessment.
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 (e.g. stroke or brain tumor), neurodevelopmental disorder (e.g. Down's syndrome), or head/neck cancer
3. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression)
4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
5. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
6. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT04240561
Study Brief:
Protocol Section:
NCT04240561