Beacon Biosignals has announced the initiation of the HEADFIRST clinical trial to assess the usability of home-based electroencephalogram (EEG) recordings in paediatric subjects with neurotypical controls and neurodevelopmental disorders.
The trial will leverage the Dreem 3S headband, a wireless EEG device cleared for adult sleep studies, now being evaluated for paediatric research.
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This headband already received the 510(k) clearance from the US Food and Drug Administration.
The HEADFIRST basket study, in collaboration with the Lennox-Gastaut Syndrome Foundation, will evaluate the Dreem headband in tracking sleep and brain activity in children with Lennox-Gastaut syndrome (LGS).
It aims to address the limitations of traditional wired EEG systems by using the headband for at-home, longitudinal monitoring.
Beacon Biosignals CEO Jacob Donoghue said: “Sleep disturbances play a critical role in neurodevelopmental disorders, significantly affecting patients and their families. However, the challenges associated with reliable data collection have led to a substantial gap in research.
“The Dreem 3S allows us to deploy clinical grade EEG monitoring while minimising burden on patients. With HEADFIRST, we’ll assess broad applications for our platform to support novel measures of brain function and trial endpoints for traditionally underserved patient populations.”
Two biopharma partners have joined the study at launch to participate in data sharing, aiming to evaluate sleep EEG biomarkers in candidates.
The trial will also utilise Beacon’s machine-learning (ML) analytics platform for measuring quantitative sleep and EEG endpoints. This could lead to new therapeutic approaches and improved patient outcome measures.
The HEADFIRST trial plans to enrol up to 300 participants across various neurodevelopmental disorders, with the LGS Foundation supporting the recruitment of the initial cohorts.
In March 2024, Beacon Biosignals received 510(k) clearance for SleepStageML, an ML software aimed at enhancing sleep analysis.
