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Eardream Data Collection in Colombia Supported by ADDF

Brain Oscillations, Sleep, and Arousal in Human Cognition - COL

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05570370
Enrollment
120
Registered
2022-10-06
Start date
2022-08-01
Completion date
2023-12-01
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Early Onset

Brief summary

Data collection based on this study will allow us to collect neurophysiological and cognitive data collected from in-ear EEG recordings of the Autosomal dominant alzheimer's disease population in Colombia

Detailed description

There is solid neurophysiological evidence indicating that abnormal brain rhythms during sleep and noradrenergic dysfunction are core components of cognitive decline and AD onset, and their related pathophysiology. Crucially, irregularities in these neurophysiological mechanisms appear to occur in an asymptomatic and pre-symptomatic stage, but their potential to identify susceptibility for triggering neurodegeneration has yet to be established. Thus, the possibility to identify such risk biomarkers in humans will require the acquisition of large-scale data related direct or indirect measurements of these physiological signatures. A possible key source to obtain such large-scale data related to sleep and noradrenergic function is the assessment of electroencephalographic recordings through non-obtrusive, low-cost, and reliable wearable sensors, alongside the use of advanced neuro-computational algorithms that link brain function and behavioral outcomes of LC function via pupilometry measurements.

Interventions

OTHERThis is an observational study

This is an observational study

Sponsors

Alzheimer's Drug Discovery Foundation
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years

Inclusion criteria

Participants fulfilling all of the following inclusion criteria are eligible for the study: Informed Consent as documented by signature mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases, except for MCI and AD in the patient population) Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Sleep disorders, known or suspected (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.) mini mental state examination (MMSE) score \> 24) Participants are not eligible if they fulfill the following

Exclusion criteria

Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly) Suspected drug- or medication abuse, or on-label sleep medication use during the time of the study Infection/disease of the auditory canal or ear drum that could worsen with EAR-DREAM application, or allergies to in-Ear electrode materials (e.g., silver) Pregnancy (not safety related, but relevant for data interpretation procedures given that pregnancy can result in sleep patterns that are different from the baseline measurements we intend to characterize) Additional non-medical

Design outcomes

Primary

MeasureTime frameDescription
Density of slow-wave activity (SWA) readout from in-ear EEG recordingsUp to 7 nights of at-home recordingsin-ear EEG will be monitored during 7 nights, the aggregated density of SWA over the 7 nights will be compared in both groups (mutation vs non-mutation carrier)
Relative phasic pupilometry responses in exploration vs exploration states in the cognitive taskexperimental session at day 1atent variables of the LC-noradrenergic neuro-computational model based on our cognitive task will indicate the state in wich the participant is (exploration vs exploitation). The relative phasic pupilometry responses in these two states will serve as a proxy of the degree of LC-noradrenergic reaction to these states. The relative reactivity will be compared in both groups (mutation vs non-mutation carriers)

Secondary

MeasureTime frameDescription
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEGexperimental session at day 1We will evaluate the the differences spatio-temporal changes in the power spectrum depending on the state in wich the participant is (exploration vs exploitation) in the cognitive task. The relative changes will be compared in both groups (mutation vs non-mutation carriers)

Countries

Colombia

Contacts

Primary ContactCarlos Tobon
carlos.tobonq@udea.edu.co219 69 00
Backup ContactRafael Polania
rafael.polania@hest.ethz.ch+41446339975

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026