Trials / Recruiting

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 500 (estimated)

Sponsor: Bitbrain · Industry
Sex: All
Age: 60 Years
Healthy volunteers: Accepted

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.

Detailed description

The sample includes 500 participants with various degrees of cognitive impairment according to standard clinical criteria, confirmed through an assessment of cognitive status in the laboratories of Bitbrain and the Miguel Servet Hospital in Zaragoza. This assessment includes an introductory session to the study and two cognitive assessment sessions lasting approximately 2 hours each. The first session includes the explanation of the study protocol, the signing of the informed consent, a short cognitive evaluation using screening tests, and the acquisition of blood samples. The second session includes a recording of brain activity using a versatile semi-dry EEG device (Bitbrain, Spain) under resting conditions and the second part of the battery of cognitive evaluations. During the second session, the battery of cognitive and behavioral tests will be completed. Outside the hospital environment, participants will receive an in-person tutorial and then take the HOGAR biosignal acquisition kit home for 2 days to collect physiological activity in their daily environment. Each day, they will record EEG in resting conditions and PSG during sleep, both self-administered or with the assistance of a family member. This includes the use of the devices Ikon and Ikon Sleep (Bitbrain, Spain) with a Microsoft Surface with user-friendly software. This cross-sectional study will allow for the examination of correlations between EEG and PSG acquired in participants' homes with all standard tests in a laboratory setting (especially tests for cognitive decline analysis), and specifically their predictive capacity using artificial intelligence tools. Subsequently, a longitudinal follow-up will explore the possibility of predicting cognitive and behavioral decline based on biosensor measurements in the home environment.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-01-15
Primary completion: 2025-12-31
Completion: 2028-12-31
First posted: 2025-05-28
Last updated: 2025-05-28

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06993207. Inclusion in this directory is not an endorsement.