BOSTON, September 18, 2024 (PR NEWSWIRE) --Beacon Biosignals Inc., the leader in at-home EEG and computational neurodiagnostics, is proud to announce the launch of HEADFIRST, the Home EEG Application and Dreem Feasibility In Research Study. The HEADFIRST basket study aims to explore the usability of home-based EEG recordings in pediatric patients with neurodevelopmental disorders and neurotypical controls. The initial phase of the study, in partnership with the Lennox-Gastaut Syndrome (LGS) Foundation, focuses on assessing the Dreem headband's usability, reliability, and clinical utility in tracking sleep and brain activity in a pediatric cohort with LGS. At study launch, two biopharma partners have signed on to participate in data sharing to gain key learnings and evaluate candidate sleep EEG biomarkers.
HEADFIRST harnesses Beacon's Dreem 3S headband, a low-profile, wireless EEG device designed for comfortable, at-home use and longitudinal monitoring*. The Dreem 3S is an FDA 510(k)-cleared medical device cleared to study sleep in adults, and is being evaluated for research purposes in pediatric populations. In this study, Beacon will assess the extent to which the Dreem3S overcomes the challenges posed by traditional wired EEG systems, which can be intrusive and disruptive for patients and their caregivers while limiting longitudinal data collection. Additionally, the study will harness Beacon's machine learning analytics platform to measure quantitative sleep and EEG endpoints, potentially paving the way for novel therapeutic approaches and improved patient outcome measures.
"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," said Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals. Dr. Donoghue added, "The Dreem 3S allows us to deploy clinical grade EEG monitoring while minimizing 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."
The HEADFIRST trial will enroll up to 300 participants across multiple neurodevelopmental disorders. The LGS Foundation will raise awareness for the study's first cohorts, ensuring that families affected by LGS have the opportunity to participate.
"Beacon's HEADFIRST study represents a significant advancement in our mission to improve the lives of those impacted by LGS," said Tracy Dixon-Salazar, PhD, Executive Director of the LGS Foundation. "The need to easily and reliably measure EEG in those with LGS is paramount to our research efforts and we are excited to support this innovative study."
About Beacon Biosignals:
Beacon Biosignals is the leading at-home EEG platform for precision drug development. Its FDA 510(k)-cleared Dreem 3 EEG headband and FDA-cleared algorithms enable first-in-human through Phase 3 clinical trials for treatments that transform the lives of patients with neurological, psychiatric, and sleep disorders. Beacon's Clinico-EEG database contains nearly 100,000 patients' brain activity data, and its cloud-native analytics platform empowers rapid interrogation of RWD/RWE for retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for disorders of the brain.
For more information about Beacon Biosignals and the HEADFIRST study, please visit Beacon Biosignals' website.
About the LGS Foundation:
The LGS Foundation is a nonprofit organization dedicated to improving the lives of individuals affected by Lennox-Gastaut Syndrome (LGS) through research, advocacy, education, and family support. The Foundation aims to promote awareness and foster research to develop better treatments and ultimately find the cures for LGS.
*Dreem 3S is being utilized for research use only in the HEADFIRST study