An Observational Study of the NeuroBell… | Clinical Trial

Key information

Conditions

EEG Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic Ischaemic Encephalopathy (HIE) Medical Devices Neonatal Seizures Neonatology Nervous System Diseases Neurologic Manifestations Neurology Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University College Cork

Cork, T12 YE02, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Do not meet inclusion criteria
No parental/guardian consent.

Treatment and study plan

NeuroBell EEG Monitor

Device

EEG Monitor

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

NeuroBell Ltd

Registry information

Official study title

An Observational Study of the NeuroBell EEG Monitor (a Portable and Wireless EEG Monitor)

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Apr 2, 2026
Registry last updated: Apr 2, 2026

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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