Eardream Data Collection in Colombia Supported by ADDF

Recruiting

• Conditions: Alzheimer Disease, Early Onset
• Interventions: Other: This is an observational study

• Registration Number: NCT05570370
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

Data collection based on this study will allow us to collect neurophysiological and cognitive data collected from in-ear EEG recordings of the Autosomal dominant alzheimer's disease population in Colombia

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: 2022-05-11
• Study Start: 2022-08-01
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

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
ADAD family members, non-mutation carriers	This is an observational study	age-matched family members (non-mutation carriers) relative to the asymptomatic/presymptomatic group
ADAD family members, mutation carriers	This is an observational study	asymptomatic and presymptomatic individuals

Primary Outcome Measures

Name	Time	Method
Density of slow-wave activity (SWA) readout from in-ear EEG recordings	Up to 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 (mutation vs non-mutation carrier)
Relative phasic pupilometry responses in exploration vs exploration states in the cognitive task	experimental session at day 1	atent 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 (mutation vs non-mutation carriers)

Secondary Outcome Measures

Name	Time	Method
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG	experimental session at day 1	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 (mutation vs non-mutation carriers)

Trial Locations

Locations (1)

Fundacion Universitaria de Antioquia; 🇨🇴 Medellín, Colombia