Eardream Data Collection in Switzerland Supported by ADDF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-06-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Healthy Aging

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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healthy young adults

between 20-40 years

This is an observational study

Intervention Type OTHER

This is an observational study

healthy older adults

between 50-75 years

This is an observational study

Intervention Type OTHER

This is an observational study

Interventions

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This is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No