An observational study in Dementia, Mild Cognitive Impairment and Dementia Alzheimers, sponsored by Bitbrain. Recruiting at 1 site in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Bitbrain · Observational
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 500 is above the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →Bitbrain is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Our goal is to assemble a diverse sample representing different cognitive impairment levels to validate our developed home kit for effective quantification and prediction of decline. The sample comprises four groups categorized by cognitive level, aiming for gender and age balance.
General Inclusion Criteria:
Inclusion Criteria 'Mild Dementia' group:
Inclusion Criteria 'Mild Cognitive Impairment' group:
Inclusion Criteria 'Subjective Cognitive Decline' group:
Inclusion criteria No impairment group:
Patients diagnosed with mild-grade dementia. These individuals will have been diagnosed by a primary care or specialized care physician, following objective clinical criteria: GDS 4 or CDR 1. Dementias in moderate and severe grades (GDS 5-7) will be excluded. Within this group, individuals diagnosed with Alzheimer's dementia, vascular dementia, or mixed dementia will be included. Any other type of dementia will be excluded.
Device: Home Lab
Patients diagnosed with mild cognitive impairment. These individuals will have been diagnosed by a primary care or specialized care physician, following objective clinical criteria: GDS 3 or CDR 0.5.
Device: Home Lab
Individuals who report subjective memory complaints and do not show objective impairment on cognitive tests. These individuals will have visited their primary care physician claiming memory complaints lasting more than 6 months, but after a standard evaluation, they do not exhibit values within the range compatible with a mild cognitive impairment diagnosis. These individuals correspond to GDS 2 or CDR 0.
Device: Home Lab
Individuals without cognitive alteration. This control group, composed of individuals who are relatives of people belonging to any of the other groups or recruited through advertisements, corresponds to GDS 1 or CDR 0.
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.
Validation of HoGar
Validation of an Instrument for Objective and Automated Quantification of Cognitive Function in Older Adults Using Devices for Autonomous Home Use.
Time frame: 1 year
Identification of Diagnostic Patterns for Cognitive Impairment Severity Using Home Biosignal Measures.
Utilizing Home Biosignal Measures to Identify Patterns for the Diagnosis of Cognitive Impairment (Including Severity), Distinguishing Them from Those Without Cognitive Impairment (Concurrently Testing the Instrument's Validity).
Time frame: 1 year
Predictive Identification of Cognitive Decline and Transitions Using Home Biosignal Measures and Longitudinal Health Data
Identification of Patterns Using Home Biosignal Measures and Longitudinal Health Data to Predict Cognitive Decline and Transitions from Mild Cognitive Impairment to Moderate/Severe Cognitive Impairment or Dementia (Testing the Predictive Validity of the Instrument)
Time frame: 1 year
Plan to share: Undecided
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