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NCT06993207Recruiting

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

Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
19 May 2025
Start date
15 Jan 2024
Primary completion date
31 Dec 2025
Lead sponsor
Bitbrain
NCT number
NCT06993207

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 15 Jan 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Criteria the registry did not label

  • 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).

Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bitbrain
Coordinator of this site? Confirm its status
ZaragozaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.