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

NCT06993207 | Recruiting

• 1 other identifier: PI23/373
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Dementia; MCI; Memory; cognitive decline; EEG; Sleep EEG

Outcome Measures

Primary Outcomes (1)

• Validation of HoGar

  Validation of an Instrument for Objective and Automated Quantification of Cognitive Function in Older Adults Using Devices for Autonomous Home Use.

  1 year

Secondary Outcomes (2)

• Identification of Diagnostic Patterns for Cognitive Impairment Severity Using Home Biosignal Measures.

  1 year

• Predictive Identification of Cognitive Decline and Transitions Using Home Biosignal Measures and Longitudinal Health Data

  1 year

Study Arms (4)

Mild Dementia

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

Mild Cognitive Impairment

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

Subjective Cognitive Decline

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

No impairment

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

Interventions

Home Lab DEVICE

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.

Mild Cognitive Impairment; Mild Dementia; No impairment; Subjective Cognitive Decline

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. 1. MILD DEMENTIA: Diagnosed individuals (150) with mild dementia (GDS 4 or CDR 1). Moderate and severe cases (GDS 5-7) are excluded, including Alzheimer's, vascular, or mixed dementia. 2. MILD COGNITIVE IMPAIRMENT: Diagnosed patients (150) with mild cognitive impairment (GDS 3 or CDR 0.5). 3. SUBJECTIVE COGNITIVE DECLINE: Individuals reporting memory complaints (100) without objective impairment (GDS 2 or CDR 0). 4. NO IMPAIRMENT: Individuals without cognitive issues (100), serving as a control group (GDS 1 or CDR 0). Balanced recruitment from family members or advertisements.

You may qualify if:

• Native Spanish speaker.
• Agree to the examination procedures and tests.
• Ability to involve a close family member or friend for functional evaluation.
• Normal or corrected-to-normal color vision.
• No medical condition requiring chronic systemic medication with psychoactive effects causing confusion.
• No severe psychiatric (according to DSM-V) or neurological diseases (epilepsy with frequent seizures (\>1/month) in the last year, multiple sclerosis, etc.).
• No diseases that may interfere with cognitive functions (renal insufficiency on hemodialysis, liver cirrhosis, chronic pulmonary disease with oxygen therapy, solid organ transplant, fibromyalgia, active cancer under treatment).
• No severe hearing and/or visual impairments, neurodevelopmental, or psychomotor disorders.
• No brain injuries that may interfere with cognitive functions (history of traumatic brain injury with parenchymal injury or macroscopic ischemic stroke of large extra-axial vessels or hemorrhagic stroke, brain surgery, brain tumors, or other causes that could result in acquired brain damage such as brain chemotherapy or radiotherapy).
• No treatment with antipsychotic agents in the 6 months prior to the initial assessment.
• No medical condition requiring chronic systemic medication with psychoactive effects causing confusion. No psychiatric or neurological medication.
• No alcohol or drug abuse.
• No serious health problems in the last 12 months (especially neurological or cardiac disorders).
• Diagnosis of Alzheimer's type dementia, based on a clinical and cognitive assessment conducted by a physician.
• Diagnosis of vascular or mixed type dementia, based on a clinical and cognitive assessment conducted by a physician.

Sponsors & Collaborators

• Bitbrain: lead
• Hospital Miguel Servet: collaborator
• Hospital Provincial Nuestra Señora de Gracia: collaborator
• Hospital Clínico Zaragoza: collaborator
• Universidad de Zaragoza: collaborator
• Instituto de Investigación Sanitaria de Aragón: collaborator

Study Sites (1)

Bitbrain

Zaragoza, Zaragoza, 50006, Spain

RECRUITING

Related Publications (2)

• Prichep LS, John ER, Ferris SH, Reisberg B, Almas M, Alper K, Cancro R. Quantitative EEG correlates of cognitive deterioration in the elderly. Neurobiol Aging. 1994 Jan-Feb;15(1):85-90. doi: 10.1016/0197-4580(94)90147-3.

  PMID: 8159266 BACKGROUND

• Prichep LS, John ER, Ferris SH, Rausch L, Fang Z, Cancro R, Torossian C, Reisberg B. Prediction of longitudinal cognitive decline in normal elderly with subjective complaints using electrophysiological imaging. Neurobiol Aging. 2006 Mar;27(3):471-81. doi: 10.1016/j.neurobiolaging.2005.07.021. Epub 2005 Oct 6.

  PMID: 16213630 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease; Mixed Dementias; Dementia, Vascular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: January 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

ES (1)