Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
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• 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.

• 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.

• 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

• 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.

• 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.

Locations
Other Locations
Spain
Bitbrain
RECRUITING
Zaragoza
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 500
Treatments
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.
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.
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.
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.
Sponsors
Collaborators: Hospital Miguel Servet, Hospital Clínico Zaragoza, Instituto de Investigación Sanitaria de Aragón, Hospital Provincial Nuestra Señora de Gracia, Universidad de Zaragoza
Leads: Bitbrain

This content was sourced from clinicaltrials.gov