Clinical trial Recruiting at 1 site Observational Ages 60 and up

Home-based brain monitoring to assess cognitive decline in older adults

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

Run by Bitbrain · NCT06993207 · Data updated 2026-11-12

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.

More Dementia trials

Quick facts

Study typeObservational
Ages60 Years and up
SexAll
Enrollment500 (estimated)
SponsorBitbrain
Industry-sponsored
Drugs / interventionschemotherapy
Locations1 site (Zaragoza, Zaragoza)
StatusRecruiting
StartedJanuary 15, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2028
Registry record updatedMay 28, 2025
Trial IDNCT06993207 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe psychiatric or neurological conditions, or those requiring chronic psychoactive medications, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies utilizing home-based EEG monitoring have shown promise in assessing cognitive function, suggesting potential success for this approach.

Who can join: the full rules

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 it's running

  • Bitbrain
    Zaragoza, Zaragoza, Spain
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.