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Eardream Data Collection in Switzerland Supported by ADDF

Brain Oscillations, Sleep, and Arousal in Human Cognition

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05320471
Enrollment
120
Registered
2022-04-11
Start date
2022-04-20
Completion date
2023-06-01
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

Healthy Aging

Brief summary

data collection based on this study will allow us to collect and calibrate neurophysiological and cognitive data collected from in-ear EEG recordings of the initial baseline/reference population in Swiss healthy individuals that can be used as reference to data collected in other populations, for instance, to be compared with any other similar dataset in the future (e.g., Alzheimer patient cohorts).

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 * Healthy young adults group: Age range 20-40 * Healthy older adults group: Age range 50-75 * Normal physical and mental status: * Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases) * 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) * Native German speaker or good understanding of German Participants are not eligible if the fulfil the following

Exclusion criteria

* Direct relatives have not been diagnosed with neuropathological conditions associated with any form of dementia (e.g., AD, MCI) * Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly) * Shift-work (e.g. work times 12am-5am) * Suspected drug- or medication abuse, or on-label sleep medication use during time of the study * Infection/disease of 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 that we intend to characterize) Additional non-medical

Design outcomes

Primary

MeasureTime frameDescription
Density of slow-wave activity (SWA) readout from in-ear EEG recordings7 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 (young vs elderly)
Relative phasic pupilometry responses in exploration vs exploration states in the cognitive task1 experimental sessionlatent 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 (young vs elderly)

Secondary

MeasureTime frameDescription
Power changes of wake EEG brain activity in close vs open eyes condition7 days of at-home recordingsWe will compute the relative changes of EEG power in close vs open eyes. The relative changes will be compared in both groups (young vs elderly)
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG1 experimental sessionWe 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 (young vs elderly)

Countries

Switzerland

Contacts

Primary ContactSilvia Hofer, MSc.
silvia. hofer @hest. ethz. ch+41 44 632 98 73

Outcome results

None listed

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