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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT06112860
Eligibility Criteria:
Inclusion Criteria:
* Over 60 years of age
* Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
* Mild to moderate bilateral hearing loss and no current hearing aid use.
* A communication partner who is able and willing to participate in the study.
* No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
* 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 (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
5. History or current fluctuating hearing loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT06112860
Study Brief:
Protocol Section:
NCT06112860