NCT06733454

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

December 9, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

Pediatric EEG

Outcome Measures

Primary Outcomes (1)

  • Number of participants who independently recorded at least 30 minutes of data

    Examine the length of time for each recording as well as qualitative information on feasibility

    Up to 2 weeks

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Child is between the ages of 1 month and 24 months of age

You may not qualify if:

  • Child has known neurodevelopment disorder
  • Legal guardian is under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10003, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 13, 2024

Study Start

August 14, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations