Eardream Data Collection in Switzerland Supported by ADDF

NCT05320471 | Unknown

• 1 other identifier: ADDF_CH
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (2)

• Density of slow-wave activity (SWA) readout from in-ear EEG 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)

  7 nights of at-home recordings

• Relative phasic pupilometry responses in exploration vs exploration states in the cognitive task

  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)

  1 experimental session

Secondary Outcomes (2)

• Power changes of wake EEG brain activity in close vs open eyes condition

  7 days of at-home recordings

• Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG

  1 experimental session

Study Arms (2)

healthy young adults

between 20-40 years

Other: This is an observational study

healthy older adults

between 50-75 years

Other: This is an observational study

Interventions

This is an observational study OTHER

This is an observational study

healthy older adults; healthy young adults

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected in healthy young adults (age range 20-40) and healthy older adults (age range 50-75).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Alzheimer's Drug Discovery Foundation: collaborator

Study Sites (1)

ETH Zurich

Zurich, Schweiz, 8057, Switzerland

RECRUITING

Study Officials

• Rafael Polania, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

• Caroline Lustenberger, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Hofer, MSc.

CONTACT

+41 44 632 98 73; silvia. hofer @hest. ethz. ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: April 11, 2022
• Study Start: April 20, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

CH (1)