Home-based brain monitoring to assess cognitive decline in older adults
Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia
This study is testing a new home kit that tracks brain activity and sleep in older adults to see if it can help spot signs of cognitive decline.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Bitbrain Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zaragoza, Zaragoza) |
| Trial ID | NCT06993207 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the HOGAR EEG/PSG monitoring kit developed by Bitbrain for evaluating cognitive function and predicting cognitive decline in older adults. It involves 500 participants with varying degrees of cognitive impairment who will undergo cognitive assessments and physiological monitoring in a home environment. Participants will receive training on using the monitoring kit, which includes EEG headbands and a mobile device for recording brain activity and sleep patterns. The study will analyze the correlation between home-acquired EEG and PSG data and standard cognitive assessments.
Who should consider this trial
Good fit: Ideal candidates include native Spanish speakers aged 65 and older with varying degrees of cognitive impairment who can involve a family member for support.
Not a fit: Patients with severe psychiatric or neurological conditions, or those requiring chronic psychoactive medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection and monitoring of cognitive decline in the aging population.
How similar studies have performed: Other studies utilizing home-based EEG monitoring have shown promise in assessing cognitive function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
General 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 this trial is running
Zaragoza, Zaragoza
- Bitbrain — Zaragoza, Zaragoza, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.