Summary: Beacon Biosignals has launched the HEADFIRST study to assess the usability of the Dreem headband for at-home EEG monitoring in pediatric patients with neurodevelopmental disorders, specifically children with Lennox-Gastaut Syndrome. The study aims to evaluate the device’s ability to track sleep and brain activity while overcoming the limitations of traditional EEG systems and exploring new sleep biomarkers.
Key Takeaways:
- The HEADFIRST study will evaluate the usability, reliability, and clinical utility of the Dreem headband for tracking sleep and brain activity in pediatric patients with neurodevelopmental disorders, specifically Lennox-Gastaut Syndrome.
- Beacon Biosignals’ machine-learning platform will be used to analyze sleep and EEG data, potentially identifying new biomarkers and supporting the development of novel therapeutic approaches.
- The study aims to overcome the limitations of traditional wired EEG systems by using the wireless Dreem 3S headband, which is designed for at-home use.
Beacon Biosignals Inc, an at-home EEG and computational neurodiagnostics company, announced the launch of HEADFIRST, the Home EEG Application and Dreem Feasibility In Research Study, 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 has received 510(k) clearance from the US Food and Drug Administration to study sleep in adults and is being evaluated for research purposes in pediatric populations.
Evaluating the Utility of Dreem3S
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,” says Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals, in a release. “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,” says Tracy Dixon-Salazar, PhD, executive director of the LGS Foundation, in a release. “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.”
Photo caption: Dreem3S headband
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