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RECRUITING
NCT06993207

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

Sponsor: Bitbrain

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-01-15

Completion Date

2028-12-31

Last Updated

2025-05-28

Healthy Volunteers

Yes

Interventions

DEVICE

Home 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.

Locations (1)

Bitbrain

Zaragoza, Zaragoza, Spain