HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
Recruiting · NCT06993207 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bitbrain
View the official record on ClinicalTrials.gov →Interventions studied
Home Lab
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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).
- Inclusion Criteria 'Mild Dementia' group:
- 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.
- Lack of autonomy in: 1. basic activities according to the Barthel Index; 2. instrumental activities according to the Lawton Index. Both indices assess dependence associated with the diagnosis of dementia, distinguishing it from the diagnosis of mild cognitive impairment.
- Inclusion Criteria 'Mild Cognitive Impairment' group:
- Diagnosis of mild cognitive impairment, based on a clinical and cognitive assessment conducted by a physician.
- Preserved autonomy in: 1. basic activities according to the Barthel Index; 2. instrumental activities according to the Lawton Index. Both indices assess dependence associated with the diagnosis of dementia, distinguishing it from the diagnosis of mild cognitive impairment
- Inclusion Criteria 'Subjective Cognitive Decline' group:
- Adherence to SCD-I criteria.
- Attendance at primary care consultation with memory complaints lasting more than 6 months.
- Absence of a diagnosis of mild cognitive impairment or dementia.
- Onset of subjective cognitive decline in the last 5 years.
- Concerns related to subjective cognitive decline (not associated with an acute event) expressed by the participant and/or an informant.
- Cognitive performance within the normal range on cognitive tests (MMSE (Mini Mental State Exam) \< 26 / MIS (Memory Impairment Screen) \< 6).
- No severe depressive symptoms, indicated by scores \> 17\* on the 30-item Geriatric Depression Scale.
- Inclusion criteria No impairment group:
- Cognitive performance within the normal range on cognitive tests (MMSE \< 26 / MIS \< 6).
- Absence of a diagnosis of mild cognitive impairment or dementia.
- Not meeting the criteria for SCD-I \[21\].
- Independent person living in their own home.
- No subjective memory complaints.
Where it is running
1 location listed.
- Bitbrain - Zaragoza, Zaragoza, Spain