REEF: Remote EEG Experiences With Families (REEF)

December 12, 2024 updated by: New York University

Remote EEG Experiences With Families

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Families with children 1-month to 24-months of age will be enrolled in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who independently recorded at least 30 minutes of data
Time Frame: Up to 2 weeks
Examine the length of time for each recording as well as qualitative information on feasibility
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NYU-IRB-FY2024-9108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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