Status:
UNKNOWN
Eardream Data Collection in Switzerland Supported by ADDF
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Alzheimer's Drug Discovery Foundation
Conditions:
Healthy Aging
Eligibility:
All Genders
20-75 years
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 Sw...
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 pa...
Eligibility Criteria
Inclusion
- 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 exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving pupillometry).
Exclusion
Key Trial Info
Start Date :
April 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05320471
Start Date
April 20 2022
End Date
June 1 2023
Last Update
October 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ETH Zurich
Zurich, Schweiz, Switzerland, 8057