HealthyREEFNCT06733454
REEF: Remote EEG Experiences With Families
An observational study of Healthy, run by New York University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Families with children 1-month to 24-months of age will be enrolled in this study.
Who may be able to join
- Child is between the ages of 1 month and 24 months of age
Who cannot join
- Child has known neurodevelopment disorder
- Legal guardian is under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Pediatric EEG
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start14 Aug 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733454
- Sponsor's protocol ID
- NYU-IRB-FY2024-9108
- Acronym
- REEF
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote EEG Experiences With Families
- ClinicalTrials.gov ID
- NCT06733454
- Acronym / sponsor ID
- REEF / NYU-IRB-FY2024-9108
- Conditions
- Healthy
- Keywords
- Pediatric EEG
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Families with children 1-month to 24-months of age will be enrolled in this study.
Key inclusion criteria (1 listed)
- Child is between the ages of 1 month and 24 months of age
Key exclusion criteria (2 listed)
- Child has known neurodevelopment disorder
- Legal guardian is under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who independently recorded at least 30 minutes of data (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.