RecruitingNot Applicable

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

Spain500 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Validation of HoGar

Timeframe: 1 year

Trial details

NCT IDNCT06993207

SponsorBitbrain

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31

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