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Enrolling by Invitation

NCT Number: NCT06733454

REEF: 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.

Enrolling by Invitation

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Key information

Conditions

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

Remote EEG Experiences With Families

Acronym: REEF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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