Actively Recruiting
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
Led by Bitbrain · Updated on 2025-05-28
500
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
B
Bitbrain
Lead Sponsor
H
Hospital Miguel Servet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or neurological diseases such as epilepsy with frequent seizures (>1/month) in the last year or multiple sclerosis
- No diseases that may interfere with cognitive functions such as renal insufficiency on hemodialysis, liver cirrhosis, chronic pulmonary disease with oxygen therapy, solid organ transplant, fibromyalgia, or active cancer under treatment
- No severe hearing or visual impairments, neurodevelopmental or psychomotor disorders
- No brain injuries that may interfere with cognitive functions, including traumatic brain injury with parenchymal injury, large ischemic or hemorrhagic stroke, brain surgery, brain tumors, or brain chemotherapy or radiotherapy
- No treatment with antipsychotic agents in the 6 months prior to the initial assessment
- 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 confirmed by a physician for the mild dementia group
- Diagnosis of vascular or mixed type dementia confirmed by a physician for the mild dementia group
- Lack of autonomy in basic and instrumental activities according to Barthel and Lawton Indices for the mild dementia group
- Diagnosis of mild cognitive impairment confirmed by a physician for the mild cognitive impairment group
- Preserved autonomy in basic and instrumental activities according to Barthel and Lawton Indices for the mild cognitive impairment group
- Adherence to SCD-I criteria for the subjective cognitive decline group
- Memory complaints lasting more than 6 months and attendance at primary care consultation for the subjective cognitive decline group
- Absence of mild cognitive impairment or dementia diagnosis for the subjective cognitive decline group
- Onset of subjective cognitive decline within the last 5 years for the subjective cognitive decline group
- Concerns related to subjective cognitive decline expressed by the participant or an informant for the subjective cognitive decline group
- Cognitive performance within the normal range on MMSE (<26) and MIS (<6) tests for the subjective cognitive decline group
- No severe depressive symptoms indicated by scores ≤17 on the 30-item Geriatric Depression Scale for the subjective cognitive decline group
- Cognitive performance within the normal range on MMSE (<26) and MIS (<6) tests for the no impairment group
- Absence of mild cognitive impairment or dementia diagnosis for the no impairment group
- Does not meet criteria for subjective cognitive decline for the no impairment group
- Independent person living in their own home for the no impairment group
- No subjective memory complaints for the no impairment group
You will not qualify if you...
- Medical condition requiring chronic systemic medication with psychoactive effects causing confusion
- Severe psychiatric disorders according to DSM-V
- Neurological diseases such as epilepsy with frequent seizures (>1/month) in the last year, multiple sclerosis, or similar
- Diseases interfering with cognitive functions like renal insufficiency on hemodialysis, liver cirrhosis, chronic pulmonary disease with oxygen therapy, solid organ transplant, fibromyalgia, or active cancer under treatment
- Severe hearing or visual impairments
- Neurodevelopmental or psychomotor disorders
- Brain injuries interfering with cognitive functions including traumatic brain injury with parenchymal injury, large ischemic or hemorrhagic stroke, brain surgery, brain tumors, brain chemotherapy or radiotherapy
- Treatment with antipsychotic agents within 6 months prior to initial assessment
- Alcohol or drug abuse
- Serious health problems in the last 12 months, especially neurological or cardiac disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bitbrain
Zaragoza, Zaragoza, Spain, 50006
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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