Healthy AgingNCT05320471
Eardream Data Collection in Switzerland Supported by ADDF
An observational study of Healthy Aging, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Healthy Aging
- What is being tested?
- This is an observational study
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Data will be collected in healthy young adults (age range 20-40) and healthy older adults (age range 50-75).
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).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
ETH Zurich
Zurich, Schweiz, 8057
Caroline Lustenberger, PhD
About this study
Official title: Brain Oscillations, Sleep, and Arousal in Human Cognition
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).
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- This is an observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| healthy young adults | between 20-40 years Receives: Other: This is an observational study | |
| healthy older adults | between 50-75 years Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 1 experimental session
Secondary outcomes (2)
Power changes of wake EEG brain activity in close vs open eyes condition
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)
Measured: 7 days of at-home recordings
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG
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)
Measured: 1 experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start20 Apr 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Responsible party
- Sponsor
- Investigators
- Rafael Polania, PhD, Principal investigator, ETH ZurichCaroline Lustenberger, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320471
- Sponsor's protocol ID
- ADDF_CH
- Status last verified
- Oct 2022
- First submitted
- 3 Feb 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oscillations, Sleep, and Arousal in Human Cognition
- ClinicalTrials.gov ID
- NCT05320471
- Acronym / sponsor ID
- ADDF_CH
- Conditions
- Healthy Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy young adults | – | Other: This is an observational studybetween 20-40 years |
| healthy older adults | – | Other: This is an observational studybetween 50-75 years |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Data will be collected in healthy young adults (age range 20-40) and healthy older adults (age range 50-75).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyThis is an observational study | Other | healthy older adults, healthy young adults |
Primary outcome
Density of slow-wave activity (SWA) readout from in-ear EEG recordings
Time frame: 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
Time frame: 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)
2 secondary outcomes
Power changes of wake EEG brain activity in close vs open eyes condition
Time frame: 7 days of at-home recordings
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG
Time frame: 1 experimental session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Aging
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Polania, PhD principal investigator
ETH Zurich
Caroline Lustenberger, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Hofer, MSc. (+41 44 632 98 73, silvia. hofer @hest. ethz. ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Density of slow-wave activity (SWA) readout from in-ear EEG recordings (time frame: 7 nights of at-home recordings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.