NCT06993207Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. máj. 28. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 500 (tervezett)
- Első benyújtás
- 2025. máj. 19.
- Kezdés
- 2024. jan. 15.
- Elsődleges befejezés
- 2025. dec. 31.
- Fő szponzor
- Bitbrain
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT06993207
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 500
- 2024. jan. 15. és az elsődleges befejezés (2025. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Kiket keres a vizsgálat
- 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.
A regiszterben nem jelölt feltételek
- 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).
Életkor a regiszterben: 60 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Bitbrain | Zaragoza | Spanyolország | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.