[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592421":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":10,"locations":32,"responsibleParty":51,"collaborators":53,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Bitbrain","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Mild Dementia",null,"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.",[13],"Device: Home Lab",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"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.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","Home Lab","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.",[15,9,23,19],[33],{"facility":5,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Zaragoza","50006","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],-0.87734,41.65606,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Eduardo López-Larraz","CONTACT","+34 931 444 823","eduardo.lopez@bitbrain.com",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54,57,60,62,64],{"name":55,"class":56},"Hospital Miguel Servet","OTHER",{"name":58,"class":59},"Hospital Provincial Nuestra Señora de Gracia","UNKNOWN",{"name":61,"class":59},"Hospital Clínico Zaragoza",{"name":63,"class":56},"Universidad de Zaragoza",{"name":65,"class":56},"Instituto de Investigación Sanitaria Aragón","100592421","home-based-brain-monitoring-with-a-garment-eeg-to-study-cognitive-decline-in-the-aging-population-100592421",false,"NCT06993207","HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population","Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia","Hogar","General Inclusion Criteria:\n\n* Native Spanish speaker.\n* Agree to the examination procedures and tests.\n* Ability to involve a close family member or friend for functional evaluation.\n* Normal or corrected-to-normal color vision.\n* No medical condition requiring chronic systemic medication with psychoactive effects causing confusion.\n* No severe psychiatric (according to DSM-V) or neurological diseases (epilepsy with frequent seizures (\\>1\u002Fmonth) in the last year, multiple sclerosis, etc.).\n* 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).\n* No severe hearing and\u002For visual impairments, neurodevelopmental, or psychomotor disorders.\n* 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).\n* No treatment with antipsychotic agents in the 6 months prior to the initial assessment.\n* No medical condition requiring chronic systemic medication with psychoactive effects causing confusion. No psychiatric or neurological medication.\n* No alcohol or drug abuse.\n* No serious health problems in the last 12 months (especially neurological or cardiac disorders).\n\nInclusion Criteria 'Mild Dementia' group:\n\n* Diagnosis of Alzheimer's type dementia, based on a clinical and cognitive assessment conducted by a physician.\n* Diagnosis of vascular or mixed type dementia, based on a clinical and cognitive assessment conducted by a physician.\n* 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.\n\nInclusion Criteria 'Mild Cognitive Impairment' group:\n\n* Diagnosis of mild cognitive impairment, based on a clinical and cognitive assessment conducted by a physician.\n* 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\n\nInclusion Criteria 'Subjective Cognitive Decline' group:\n\n* Adherence to SCD-I criteria.\n* Attendance at primary care consultation with memory complaints lasting more than 6 months.\n* Absence of a diagnosis of mild cognitive impairment or dementia.\n* Onset of subjective cognitive decline in the last 5 years.\n* Concerns related to subjective cognitive decline (not associated with an acute event) expressed by the participant and\u002For an informant.\n* Cognitive performance within the normal range on cognitive tests (MMSE (Mini Mental State Exam) \\\u003C 26 \u002F MIS (Memory Impairment Screen) \\\u003C 6).\n* No severe depressive symptoms, indicated by scores \\> 17\\* on the 30-item Geriatric Depression Scale.\n\nInclusion criteria No impairment group:\n\n* Cognitive performance within the normal range on cognitive tests (MMSE \\\u003C 26 \u002F MIS \\\u003C 6).\n* Absence of a diagnosis of mild cognitive impairment or dementia.\n* Not meeting the criteria for SCD-I \\[21\\].\n* Independent person living in their own home.\n* No subjective memory complaints.",true,"ALL","60 Years",{"count":78,"type":79},500,"ESTIMATED","3 Years","OBSERVATIONAL","This study will investigate the validity of the HOGAR EEG\u002FPSG 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.",[84,15,85,86,19,87],"Dementia","Dementia Alzheimers","Dementia, Mixed","Dementia, Vascular",[84,89,90,91,92,93],"MCI","Memory","cognitive decline","EEG","Sleep EEG","2025-05-19",{"date":96,"type":97},"2025-05-28","ACTUAL",{"date":99,"type":97},"2024-01-15",{"date":101,"type":79},"2028-12-31",{"name":5,"class":6},1]