Actively Recruiting

Age: 60Years +
All Genders
Healthy Volunteers
ID06993207

Validation of a Home-use Instrument for Quantifying Cognitive Function in People at Risk of Dementia

Led by Bitbrain · Updated on 2025-05-28

500

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

B

Bitbrain

Lead Sponsor

H

Hospital Miguel Servet

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool to measure brain activity and sleep patterns at home for older adults, aiming to detect and predict cognitive decline. The study includes 500 participants with varying degrees of cognitive impairment, confirmed by clinical assessments. This observational study also plans a longitudinal follow-up to explore the predictive power of home biosensor data for cognitive and behavioral changes over time. Participants are divided into four groups based on cognitive status: mild dementia, mild cognitive impairment, subjective cognitive decline, and no cognitive impairment. All participants undergo an introductory session with informed consent, followed by two cognitive assessment sessions in a laboratory setting. They then receive training to use the HOGAR biosignal kit at home for two days, recording EEG while resting and PSG during sleep using devices with user-friendly software. During the study, participants complete cognitive and behavioral tests in both laboratory and home environments. Blood samples are collected, and brain activity is recorded using a semi-dry EEG device. Researchers will compare home and lab measurements to standard tests, analyze diagnostic patterns, and validate the monitoring kit. The study will last about 3 to 6 weeks per participant, with safety and cognitive function monitored throughout.

CONDITIONS

Brief Title

HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Native Spanish speaker
  • Age 60 years or older
  • Agree to examination procedures and tests
  • Ability to involve a close family member or friend for functional evaluation
  • Normal or corrected normal color vision
  • No chronic systemic medication with psychoactive effects causing confusion
  • No severe psychiatric or neurological diseases such as epilepsy with frequent seizures or multiple sclerosis
  • No diseases interfering with cognitive functions like renal insufficiency on hemodialysis, liver cirrhosis, chronic pulmonary disease with oxygen therapy, solid organ transplant, fibromyalgia, or active cancer under treatment
  • No severe hearing or visual impairments, neurodevelopmental or psychomotor disorders
  • No brain injuries that interfere with cognitive functions such as traumatic brain injury with parenchymal injury, large ischemic or hemorrhagic stroke, brain surgery, brain tumors, or brain chemotherapy/radiotherapy
  • No treatment with antipsychotic agents in the 6 months prior to assessment
  • No alcohol or drug abuse
  • No serious health problems in the last 12 months, especially neurological or cardiac
  • For Mild Dementia group: diagnosed Alzheimer's, vascular, or mixed dementia with loss of autonomy in basic and instrumental activities
  • For Mild Cognitive Impairment group: diagnosed mild cognitive impairment with preserved autonomy in basic and instrumental activities
  • For Subjective Cognitive Decline group: memory complaints over 6 months without objective impairment, onset within last 5 years, no severe depressive symptoms
  • For No Impairment group: normal cognitive test results, no diagnosis of MCI or dementia, independent living, no memory complaints
Not Eligible

You will not qualify if you...

  • Diagnosed moderate or severe dementia (GDS 5-7)
  • Dementia types other than Alzheimer's, vascular, or mixed
  • Severe psychiatric disorders per DSM-V
  • Epilepsy with frequent seizures (>1/month) in the last year
  • Neurological diseases like multiple sclerosis
  • Medical conditions interfering with cognitive function
  • Brain injuries causing acquired brain damage
  • Treatment with antipsychotic medication within 6 months prior to assessment
  • Alcohol or drug abuse
  • Serious health problems in the past year, especially neurological or cardiac

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 3 to 6 weeks

Participants attend sessions at the laboratory for cognitive and behavioral assessments, including blood sample collection and brain activity recording using EEG.

2 visits (in-person)

Home Monitoring

Duration - 2 days

Participants receive an in-person tutorial and then use the biosignal acquisition kit at home for 2 days to record EEG and PSG in daily life and sleep conditions.

1 visit (in-person tutorial) plus 2 days of home recording

Long-term Monitoring

Duration - Up to 1 year

Participants may be followed longitudinally to explore the prediction of cognitive and behavioral decline based on home biosensor measurements.

Follow-up visits or assessments may occur as part of long-term observation

Trial Site Locations

Total: 1 location

1

Bitbrain

Zaragoza, Zaragoza, Spain, 50006

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Prediction of longitudinal cognitive decline in normal elderly with subjective complaints using electrophysiological imaging.

L S Prichep, E R John, S H Ferris...

https://pubmed.ncbi.nlm.nih.gov/16213630