RecruitingNCT06993207

HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population

Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia

Sponsor

Bitbrain

Enrollment

500 participants

Start Date

Jan 15, 2024

Study Type

OBSERVATIONAL

Conditions

Dementia Dementia, Vascular Dementia, Mixed Dementia Alzheimers Mild Cognitive Impairment Subjective Cognitive Decline

Summary

This study will investigate the validity of the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool for characterizing and assessing cognitive function in older adults, as well as for detecting and predicting cognitive decline. The kit consists of two EEG headbands and a mobile computing device that allows measurements of sleep patterns (PSG) and brain activity (EEG) in a home environment.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable EEG headband (a garment that measures brain electrical activity at home) can track cognitive changes over time in people with mild dementia, and compare patterns between those with Alzheimer's versus vascular dementia. **You may be eligible if...** - You are a native Spanish speaker - You have been clinically diagnosed with Alzheimer's or vascular dementia (mild stage), OR you have normal cognition (as a comparison group) - You have a close family member or friend who can help with assessments - You have normal or corrected color vision **You may NOT be eligible if...** - You have severe psychiatric or neurological conditions (such as epilepsy with frequent seizures, multiple sclerosis) - You have significant vision or hearing impairment - You have had a stroke, brain tumor, brain surgery, or brain injury - You are on antipsychotic medications or have been in the past 6 months - You have alcohol or drug abuse problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHome Lab

The main goal is to comprehensively assess the cognitive and behavioral status of all participants, regardless of their assigned groups. Validated clinical tests (considered the gold standard) will be used, with measurements taken at participants' homes using a biosignal monitoring kit-the focal tool of the project. Whether in the control or specific groups, all participants will undergo an identical battery of tests in both the laboratory and home settings. The study design includes an introductory session for participants to understand the study's purpose and sign informed consent. Following consent, participants will have three sessions within a 3 to 6-week timeframe: one for autonomous technology use instruction and the other two for cognitive and functional evaluations.