EEGNCT07508670
An Observational Study of the NeuroBell EEG Monitor
An observational study of EEG and Neonatology, run by University College Cork at 1 site in Ireland.
Trial summary
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor). Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- EEG, Neonatology, Seizure
- What is being tested?
- NeuroBell EEG Monitor
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteIreland
- Study dates
- 2 Sep 2024to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (male or female) admitted to the NICU of Cork University Maternity Hospital (CUMH) will be enrolled. The investigational device does not require any additional electrodes to be placed on the participants and does not cause interruption to standard practice.
Who may be able to join
- Full-term neonates (born between 36-44 weeks gestational age), in whom EEG monitoring is indicated as part of standard clinical care or as part of a separate study in which they are enrolled
Who cannot join
- Do not meet inclusion criteria
- No parental/guardian consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of the NeuroBell EEG Monitor (a Portable and Wireless EEG Monitor)
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
Read the detailed description
The objective of the clinical investigation is to evaluate the signal quality of the NeuroBell EEG Monitor (hereinafter referred to as the investigational device) for use in acquiring neonatal EEG compared to a conventional EEG device.
- Conditions
- EEG, Neonatology, Seizure, Neurology, Hypoxic Ischaemic Encephalopathy (HIE), Neonatal Seizures
- Being tested
- NeuroBell EEG Monitor
- Keywords
- Observational, Neonatal seizure, medical device
- Medical subject headings
- Seizures, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroBell EEG MonitorDevice
EEG Monitor
| Study group | Role | What they receive |
|---|---|---|
| Full-term neonates | Full-term neonates (born between 36-44 weeks gestational age), in whom EEG monitoring is indicated as part of standard clinical care or as part of a separate study in which they are enrolled. Receives: Device: NeuroBell EEG Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of EEG signals from investigational device compared with standard of care EEG device
EEG signals recorded by the investigational device will be compared to the EEG signals recorded by the conventional EEG monitor. Confirmation that the investigational device records EEG signals are suitable for clinical interpretation.
Measured: From enrollment to the end off EEG analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start2 Sep 2024
- Primary completion1 Oct 2025
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEGStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroBell Ltd
- Responsible party
- Sponsor
- Investigators
- Brian Walsh, MD, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508670
- Sponsor's protocol ID
- MOS01/2023
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the NeuroBell EEG Monitor (a Portable and Wireless EEG Monitor)
- ClinicalTrials.gov ID
- NCT07508670
- Acronym / sponsor ID
- MOS01/2023
- Conditions
- EEG, Neonatology, Seizure, Neurology, Hypoxic Ischaemic Encephalopathy (HIE), Neonatal Seizures
- Keywords
- Observational, Neonatal seizure, medical device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- NeuroBell Ltd
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 2 Apr 2026 (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.
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
Detailed description
The objective of the clinical investigation is to evaluate the signal quality of the NeuroBell EEG Monitor (hereinafter referred to as the investigational device) for use in acquiring neonatal EEG compared to a conventional EEG device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-term neonates | – | Device: NeuroBell EEG MonitorFull-term neonates (born between 36-44 weeks gestational age), in whom EEG monitoring is indicated as part of standard clinical care or as part of a separate study in which they are enrolled. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (male or female) admitted to the NICU of Cork University Maternity Hospital (CUMH) will be enrolled. The investigational device does not require any additional electrodes to be placed on the participants and does not cause interruption to standard practice.
Key inclusion criteria (1 listed)
- Full-term neonates (born between 36-44 weeks gestational age), in whom EEG monitoring is indicated as part of standard clinical care or as part of a separate study in which they are enrolled
Key exclusion criteria (2 listed)
- Do not meet inclusion criteria
- No parental/guardian consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroBell EEG MonitorEEG Monitor | Device | Full-term neonates |
Primary outcome
Evaluation of EEG signals from investigational device compared with standard of care EEG device
Time frame: From enrollment to the end off EEG analysis
EEG signals recorded by the investigational device will be compared to the EEG signals recorded by the conventional EEG monitor. Confirmation that the investigational device records EEG signals are suitable for clinical interpretation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brian Walsh, MD principal investigator
Cork University Hospital
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 EEG and Neonatology, run by University College Cork at 1 site in Ireland.
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: finished, as of the sponsor's last update on 2 Apr 2026. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of EEG signals from investigational device compared with standard of care EEG device (time frame: From enrollment to the end off EEG analysis). 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 2 Apr 2026.