Eardream Data Collection in Switzerland Supported by ADDF

Recruiting

• Conditions: Healthy Aging
• Interventions: Other: This is an observational study

• Registration Number: NCT05320471
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-11
• Study Start: 2022-04-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy young adults	This is an observational study	between 20-40 years
healthy older adults	This is an observational study	between 50-75 years

Primary Outcome Measures

Name	Time	Method
Density of slow-wave activity (SWA) readout from in-ear EEG recordings	7 nights of at-home recordings	in-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 task	1 experimental session	latent 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 Outcome Measures

Name	Time	Method
Power changes of wake EEG brain activity in close vs open eyes condition	7 days of at-home recordings	We 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 EEG	1 experimental session	We 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)

Trial Locations

Locations (1)

ETH Zurich; 🇨🇭 Zurich, Schweiz, Switzerland