Beacon Biosignals, the leader in at-home EEG and computational neurodiagnostics, announced a collaboration with Takeda to conduct at-home sleep monitoring to support clinical trials for sleep disorders leveraging Beacon’s neurophysiology platform, including the FDA-cleared Dreem 3S EEG headband, AI-powered analytics, and clinico-EEG database.

Understanding the importance of sleep-related disturbances is critical to improving the diagnostic journey of sleep disorders such as narcolepsy and enabling more personalized treatment options. Quantitative sleep data have historically been difficult to collect and analyze at the speed and scale necessary to support clinical development. This collaboration enables Takeda to collect laboratory-quality sleep data from a patient’s home, longitudinally, and at-scale using Beacon’s advanced wearable sleep EEG hardware, AI-powered analytics, and clinical operations services.

“Takeda is committed to developing life-transforming therapies for areas of highest unmet need, including narcolepsy and other sleep-wake disorders. In partnering with Beacon, we will now have access to real-time, longitudinal sleep data that better reflects the daily burden of living with these disorders,” said Elena Koundourakis, head of the Orexin Franchise Development and Neuroscience Portfolio Strategy at Takeda. “The Beacon Platform will be used to inform our clinical trial designs including defining quantitative, digital endpoints based on objective measures of sleep patterns, which could support more tailored treatment approaches and improve the diagnostic journey for patients.”

The Beacon Platform facilitates comprehensive insights into sleep and wake brain function. The Dreem 3S headband, which recently earned FDA 510(k) medical device clearance, enables longitudinal sleep data collection from patients in the comfort of their home and via self-application without the need for specialized technologists. Collecting these data remotely alleviates the patient burden of travelling to a sleep lab and may improve the diagnostic journey by enabling faster sleep testing. Additionally, Beacon’s advanced machine learning algorithms, which are also FDA 510(k)-cleared, rapidly analyze EEG data to capture validated clinical trial endpoints and score sleep stages with equivalent performance to human experts. In this collaboration with Takeda, Beacon’s AI-powered technologies establish a foundation for improved diagnostics and support the development of interventions for disorders with excessive daytime sleepiness or disturbed nighttime sleep.

Jacob Donoghue, MD, PhD, CEO of Beacon, expressed excitement about the collaboration, stating, "Beacon is thrilled to work with Takeda to support the advancement of therapies that can improve the lives of patients. Sleep is fundamental to brain health and together we’re setting a new standard for rigorously measuring sleep in clinical trials. By improving the patient experience and operationalizing at-home sleep assessments at scale, we are generating unprecedented, high-quality data on brain function during drug development. This paves the way for real-world use in clinical diagnostics across neurological and psychiatric indications."