REEF: Remote EEG Experiences With Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 1 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote EEG Experiences With Families
Overview
The goal of this observational study is to learn about the usability of portable EEG sensors (REMI) in the home with infants and young children. The main question it aims to answer is: Can families comfortably use portable EEG sensors (REMI) in the home with their children? Families will wear the REMI sensors for an extended period of time (30 minutes to 1 week) and answer online survey questions.
Detailed description
There has been significant innovation in remote testing procedures over the past few years, accelerated in part as a result of the COVID-19 pandemic-related testing restrictions. Shifts to remote testing have included standardization of methods for survey administration and adaptations of traditional in-lab paradigms for use in remote assessments. The current project will develop and standardize a remote protocol measuring infant brain function using wireless, portable, user-friendly, single-channel EEG sensors. Infant cortical activity will be collected using the REMI (Remote EEG Monitoring System), a wireless, single-channel sensor. The sensors are applied to the head using specially designed infant-friendly adhesive stickers (to avoid skin irritation). Families of children between the ages of 1 month and 24 months will be eligible to participate in this study. Experimenters will initiate the sensors and will instruct families on how to use the REMI system independently (i.e., changing adhesive stickers when necessary). Families will then record child EEG for an extended period of time (30 minutes to 2 weeks). When recording is complete, the family will mail back all equipment to the lab.
Primary outcome measures
- Number of participants who independently recorded at least 30 minutes of data [Time frame: Up to 2 weeks]
Eligibility criteria
Inclusion criteria
- Child is between the ages of 1 month and 24 months of age
Exclusion criteria
- Child has known neurodevelopment disorder
- Legal guardian is under 18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- New York University — New York
Identifiers
NCT: NCT06733454 · NYU-IRB-FY2024-9108