DementiaHogarNCT06993207
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
An observational study of Dementia and Mild Cognitive Impairment, run by Bitbrain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers
- What is being tested?
- Home Lab
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our goal is to assemble a diverse sample representing different cognitive impairment levels to validate our developed home kit for effective quantification and prediction of decline. The sample comprises four groups categorized by cognitive level, aiming for gender and age balance. 1. MILD DEMENTIA: Diagnosed individuals (150) with mild dementia (GDS 4 or CDR 1). Moderate and severe cases (GDS 5-7) are excluded, including Alzheimer's, vascular, or mixed dementia. 2. MILD COGNITIVE IMPAIRMENT: Diagnosed patients (150) with mild cognitive impairment (GDS 3 or CDR 0.5). 3. SUBJECTIVE COGNITIVE DECLINE: Individuals reporting memory complaints (100) without objective impairment (GDS 2 or CDR 0). 4. NO IMPAIRMENT: Individuals without cognitive issues (100), serving as a control group (GDS 1 or CDR 0). Balanced recruitment from family members or advertisements.
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Bitbrain
Zaragoza, Zaragoza, 50006
Eduardo López-Larraz, +34 931 444 823, eduardo.lopez@bitbrain.com
About this study
Official title: Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia
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.
Read the detailed description
The sample includes 500 participants with various degrees of cognitive impairment according to standard clinical criteria, confirmed through an assessment of cognitive status in the laboratories of Bitbrain and the Miguel Servet Hospital in Zaragoza. This assessment includes an introductory session to the study and two cognitive assessment sessions lasting approximately 2 hours each. The first session includes the explanation of the study protocol, the signing of the informed consent, a short cognitive evaluation using screening tests, and the acquisition of blood samples. The second session includes a recording of brain activity using a versatile semi-dry EEG device (Bitbrain, Spain) under resting conditions and the second part of the battery of cognitive evaluations. During the second session, the battery of cognitive and behavioral tests will be completed.
Outside the hospital environment, participants will receive an in-person tutorial and then take the HOGAR biosignal acquisition kit home for 2 days to collect physiological activity in their daily environment. Each day, they will record EEG in resting conditions and PSG during sleep, both self-administered or with the assistance of a family member. This includes the use of the devices Ikon and Ikon Sleep (Bitbrain, Spain) with a Microsoft Surface with user-friendly software.
This cross-sectional study will allow for the examination of correlations between EEG and PSG acquired in participants' homes with all standard tests in a laboratory setting (especially tests for cognitive decline analysis), and specifically their predictive capacity using artificial intelligence tools. Subsequently, a longitudinal follow-up will explore the possibility of predicting cognitive and behavioral decline based on biosensor measurements in the home environment.
- Conditions
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mixed, Subjective Cognitive Decline, Dementia, Vascular
- Being tested
- Home Lab
- Keywords
- Dementia, MCI, Memory, cognitive decline, EEG, Sleep EEG
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease, Mixed Dementias, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home LabDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild Dementia | 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. Receives: Device: Home Lab | |
| 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. Receives: Device: Home Lab | |
| 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. Receives: Device: Home Lab | |
| 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. Receives: Device: Home Lab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of HoGar
Validation of an Instrument for Objective and Automated Quantification of Cognitive Function in Older Adults Using Devices for Autonomous Home Use.
Measured: 1 year
Secondary outcomes (2)
Identification of Diagnostic Patterns for Cognitive Impairment Severity Using Home Biosignal Measures.
Utilizing Home Biosignal Measures to Identify Patterns for the Diagnosis of Cognitive Impairment (Including Severity), Distinguishing Them from Those Without Cognitive Impairment (Concurrently Testing the Instrument's Validity).
Measured: 1 year
Predictive Identification of Cognitive Decline and Transitions Using Home Biosignal Measures and Longitudinal Health Data
Identification of Patterns Using Home Biosignal Measures and Longitudinal Health Data to Predict Cognitive Decline and Transitions from Mild Cognitive Impairment to Moderate/Severe Cognitive Impairment or Dementia (Testing the Predictive Validity of the Instrument)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Bitbrain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Hospital Provincial Nuestra Señora de Gracia, Hospital Clínico Zaragoza, Universidad de Zaragoza, Instituto de Investigación Sanitaria Aragón
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993207
- Sponsor's protocol ID
- PI23/373
- Acronym
- Hogar
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prichep LS, John ER, Ferris SH, Rausch L, Fang Z, Cancro R, Torossian C, Reisberg B. Prediction of longitudinal cognitive decline in normal elderly with subjective complaints using electrophysiological imaging. Neurobiol Aging. 2006 Mar;27(3):471-81. doi: 10.1016/j.neurobiolaging.2005.07.021. Epub 2005 Oct 6.
PubMed 16213630Prichep LS, John ER, Ferris SH, Reisberg B, Almas M, Alper K, Cancro R. Quantitative EEG correlates of cognitive deterioration in the elderly. Neurobiol Aging. 1994 Jan-Feb;15(1):85-90. doi: 10.1016/0197-4580(94)90147-3.
PubMed 8159266
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Home-use Instrument for the Quantification of Cognitive Function in a Population at Risk of Dementia
- ClinicalTrials.gov ID
- NCT06993207
- Acronym / sponsor ID
- Hogar / PI23/373
- Conditions
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mixed, Subjective Cognitive Decline, Dementia, Vascular
- Keywords
- Dementia, MCI, Memory, cognitive decline, EEG, Sleep EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- BitbrainIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Hospital Provincial Nuestra Señora de Gracia, Hospital Clínico Zaragoza, Universidad de Zaragoza, Instituto de Investigación Sanitaria Aragón
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sample includes 500 participants with various degrees of cognitive impairment according to standard clinical criteria, confirmed through an assessment of cognitive status in the laboratories of Bitbrain and the Miguel Servet Hospital in Zaragoza. This assessment includes an introductory session to the study and two cognitive assessment sessions lasting approximately 2 hours each. The first session includes the explanation of the study protocol, the signing of the informed consent, a short cognitive evaluation using screening tests, and the acquisition of blood samples. The second session includes a recording of brain activity using a versatile semi-dry EEG device (Bitbrain, Spain) under resting conditions and the second part of the battery of cognitive evaluations. During the second session, the battery of cognitive and behavioral tests will be completed.
Outside the hospital environment, participants will receive an in-person tutorial and then take the HOGAR biosignal acquisition kit home for 2 days to collect physiological activity in their daily environment. Each day, they will record EEG in resting conditions and PSG during sleep, both self-administered or with the assistance of a family member. This includes the use of the devices Ikon and Ikon Sleep (Bitbrain, Spain) with a Microsoft Surface with user-friendly software.
This cross-sectional study will allow for the examination of correlations between EEG and PSG acquired in participants' homes with all standard tests in a laboratory setting (especially tests for cognitive decline analysis), and specifically their predictive capacity using artificial intelligence tools. Subsequently, a longitudinal follow-up will explore the possibility of predicting cognitive and behavioral decline based on biosensor measurements in the home environment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Dementia | – | Device: Home LabPatients 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. |
| Mild Cognitive Impairment | – | Device: Home LabPatients 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. |
| Subjective Cognitive Decline | – | Device: Home LabIndividuals 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. |
| No impairment | – | Device: Home LabIndividuals 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our goal is to assemble a diverse sample representing different cognitive impairment levels to validate our developed home kit for effective quantification and prediction of decline. The sample comprises four groups categorized by cognitive level, aiming for gender and age balance. 1. MILD DEMENTIA: Diagnosed individuals (150) with mild dementia (GDS 4 or CDR 1). Moderate and severe cases (GDS 5-7) are excluded, including Alzheimer's, vascular, or mixed dementia. 2. MILD COGNITIVE IMPAIRMENT: Diagnosed patients (150) with mild cognitive impairment (GDS 3 or CDR 0.5). 3. SUBJECTIVE COGNITIVE DECLINE: Individuals reporting memory complaints (100) without objective impairment (GDS 2 or CDR 0). 4. NO IMPAIRMENT: Individuals without cognitive issues (100), serving as a control group (GDS 1 or CDR 0). Balanced recruitment from family members or advertisements.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home LabThe 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. | Device | Mild Cognitive Impairment, Mild Dementia, No impairment, Subjective Cognitive Decline |
Primary outcome
Validation of HoGar
Time frame: 1 year
Validation of an Instrument for Objective and Automated Quantification of Cognitive Function in Older Adults Using Devices for Autonomous Home Use.
2 secondary outcomes
Identification of Diagnostic Patterns for Cognitive Impairment Severity Using Home Biosignal Measures.
Time frame: 1 year
Predictive Identification of Cognitive Decline and Transitions Using Home Biosignal Measures and Longitudinal Health Data
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 16213630Prichep LS, John ER, Ferris SH, Rausch L, Fang Z, Cancro R, Torossian C, Reisberg B. Prediction of longitudinal cognitive decline in normal elderly with subjective complaints using electrophysiological imaging. Neurobiol Aging. 2006 Mar;27(3):471-81. doi: 10.1016/j.neurobiolaging.2005.07.021. Epub 2005 Oct 6.
- Results publication: PubMed 8159266Prichep LS, John ER, Ferris SH, Reisberg B, Almas M, Alper K, Cancro R. Quantitative EEG correlates of cognitive deterioration in the elderly. Neurobiol Aging. 1994 Jan-Feb;15(1):85-90. doi: 10.1016/0197-4580(94)90147-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment, run by Bitbrain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of HoGar (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.