AI and Wearable EEG to Redefine Sleep Disorder Drug Trials

BOSTON, MA – December 16, 2025 – A new collaboration is set to challenge the decades-old methods for evaluating treatments for debilitating sleep disorders. Beacon Biosignals, a pioneer in AI-driven neurophysiology, announced today it is partnering with Harmony Biosciences to integrate objective brain-monitoring technology into late-stage clinical trials for narcolepsy and idiopathic hypersomnia.

The partnership will embed Beacon’s wearable electroencephalography (EEG) technology into two of Harmony’s Phase 3 studies for its investigational therapy, HBS-301. This move signals a significant shift in drug development, aiming to supplement traditional subjective patient questionnaires with objective, real-world data on brain activity, potentially accelerating the path to more effective therapies.

A New Lens on an Invisible Illness

For millions of people worldwide, narcolepsy and idiopathic hypersomnia are not merely about feeling tired; they are chronic, life-altering neurological conditions. Both are characterized by severe excessive daytime sleepiness (EDS), but narcolepsy can also involve cataplexy (sudden muscle weakness), while idiopathic hypersomnia features prolonged, unrefreshing sleep and severe “sleep inertia,” a state of profound grogginess and cognitive impairment upon waking.

Historically, diagnosing these conditions and measuring the effectiveness of new treatments has relied heavily on subjective tools. Patients are often asked to fill out questionnaires like the Epworth Sleepiness Scale (ESS), rating their likelihood of dozing off in various situations. While useful, these self-reported scales can be inconsistent and may not fully capture the true burden of the disease. In-clinic tests like the Multiple Sleep Latency Test (MSLT) provide objective data but only offer a snapshot in an artificial lab environment.

This gap between subjective feeling and objective measurement has long been a challenge for both patients and clinicians. Patient advocacy groups have frequently highlighted the grueling “diagnostic odyssey” many individuals endure, often lasting years and involving misdiagnoses. They emphasize a critical need for better diagnostic tools and more reliable methods to track treatment progress, which could lead to more personalized and effective care.

The Technology Driving the Change

At the heart of this new initiative is Beacon Biosignals' innovative platform, which combines a wearable, FDA 510(k)-cleared EEG headband with powerful AI algorithms. The device, known as the Waveband EEG headband, is designed for at-home use, allowing for the continuous capture of brain data across consecutive nights and during daytime naps. Its wireless, low-profile design enables monitoring in a patient's real-world environment, a stark contrast to the limitations of a hospital sleep lab.

Beacon’s AI-driven platform then analyzes these complex neural datasets to extract clinically meaningful insights. By continuously measuring nighttime sleep quality and the frequency and duration of daytime sleep episodes, the technology provides a far more precise and objective view of hypersomnolence.

“This collaboration with Harmony represents an important step toward bringing quantitative sleep neurophysiology into late-stage drug development,” said David Matthews, PhD, President of Life Sciences at Beacon Biosignals, in the official announcement. “Measuring objective sleep EEG data alongside subjective endpoints like patient-reported outcomes improves the precision and interpretability of treatment outcomes, and we expect it will accelerate the path toward better therapies for people living with hypersomnia disorders.”

This approach doesn't aim to replace patient feedback but to enrich it, creating a comprehensive picture of how a treatment is working both physiologically and experientially.

Redefining Clinical Trial Endpoints

The integration of objective biomarkers into a Phase 3 trial—the final and most critical stage before seeking regulatory approval—is a particularly noteworthy development. Harmony Biosciences, a commercial-stage company whose flagship product WAKIX (pitolisant) is already approved for narcolepsy, is making a strategic bet on innovation to solidify the clinical profile of its pipeline asset, HBS-301.

The competitive landscape for sleep disorder treatments is intensifying, with novel mechanisms like orexin receptor agonists emerging as potential game-changers. By incorporating Beacon's technology, Harmony aims to generate a more robust data package for HBS-301. The objective EEG data could prove crucial in demonstrating the drug's efficacy with a level of precision that subjective scales alone cannot provide. This is especially relevant for idiopathic hypersomnia, where Harmony's previous trial with pitolisant showed positive trends but did not meet its primary endpoint based on a subjective scale.

The collaboration will allow researchers to identify specific EEG biomarkers that correlate with treatment response. These digital biomarkers could inform dose selection, provide definitive evidence of efficacy, and even help identify subgroups of patients who are most likely to benefit from the therapy—a cornerstone of precision medicine.

“Harmony Biosciences is committed to advancing scientific understanding and treatment of central disorders of hypersomnolence,” stated Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. “By integrating Beacon’s innovative EEG platform into our HBS-301 Phase 3 studies, we aim to bring new levels of objectivity and reliability to clinical endpoints in hypersomnia disorders, enhancing our ability to evaluate treatment benefit and better serve the patient community.”

Strategic Stakes and the Future of Neuro-Pharma

This partnership represents more than just an enhancement to a single clinical trial; it highlights a pivotal trend in the pharmaceutical industry. For Harmony Biosciences, which boasts a strong financial position with over $825 million in revenue in the last year, this is a calculated investment to de-risk a high-stakes development program and establish a competitive advantage. Success could not only lead to a new approved therapy but also validate a more sophisticated approach to neurological drug development.

For Beacon Biosignals, this collaboration is a powerful endorsement of its platform. Having its technology adopted in a late-stage trial by an established pharmaceutical partner serves as a significant validation, likely to attract further interest from other drug developers working in neurology, psychiatry, and sleep medicine. It positions Beacon as a key enabler of next-generation clinical research.

Ultimately, this alliance could help set a new industry standard. As the U.S. Food and Drug Administration shows increasing openness to digital health technologies and novel clinical endpoints, the successful use of objective, AI-analyzed biomarkers could pave the way for their broader adoption. This shift promises to make clinical trials more efficient, reduce uncertainty in efficacy assessment, and accelerate the delivery of groundbreaking treatments to patients who desperately need them. As regulators and investors watch closely, the fusion of advanced neurotechnology and pharmaceutical science may soon become the new gold standard for tackling the most complex neurological disorders.