Neuro health technology company Beacon Biosignals has received FDA 510(k) Clearance for the Dreem 3S, an electroencephalogram (EEG)-based sleep monitoring device to measure sleep patterns.
The device is an advanced wearable headband with integrated machine learning algorithms to capture brain activity data to monitor sleep architecture and help diagnose disturbed sleep.
The at-home sleep monitoring device has the potential for continuous 24-hour recording, making it simpler for users to continuously monitor their sleep patterns at home instead of going into a lab for traditional polysomnography (PSG)-based sleep testing.
Beacon said the FDA clearance marks it as equivalent to in-lab PSG for the assessment of sleep staging.
It says the Dreem 3S is the first dry-EEG medical device of its kind, allowing for convenient EEG data collection at home and providing automated sleep staging according to the American Academy of Sleep Medicine (AASM) classification.
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It is estimated that 50 to 70 million Americans suffer from sleep disorders. They can be associated with underlying conditions such as major depressive disorder and neurodegenerative diseases.
Beacon focuses on developing treatments for neurological, psychiatric and sleep disorders. The company purchased Dreem’s research and development business in July this year.
“Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions,” said Beacon Biosignals CEO and co-founder Jacob Donoghue, in the company’s press release.
“We are enabling high-fidelity, overnight brain activity to be efficiently collected in the patient’s home, opening new doors for clinical trial endpoints,” he said.
Beacon said, traditionally, capturing sleep endpoints requires patients to spend nights in sleep laboratories, or relies on surrogate measures of sleep activity via wrist actigraphy, which isn’t always very precise. The Dreem 3S aims to revolutionize this.
Dreem 3S is a fully at-home device that users can use independently from the comfort of their own homes. The Dreem 3S has six electrodes and an integrated accelerometer to measure head movement and body position while optimizing continuous high-quality data collection. The device records for a period of 24 hours, allowing for longitudinal monitoring.
In a clinical usability study, the Dreem 3S was found to be well tolerated and could generate clinical-grade data in home settings.
The device’s sleep staging algorithm performed as well or better than human experts as reported in literature, according to Beacon.
Beacon said the milestone FDA clearance complements the company’s machine learning platform for EEG and PSG, “enabling rapid analysis of large clinical neurophysiology datasets.”
Alexander Chan, PhD, Beacon’s Vice President of Analytics and Machine Learning explained that, “The advanced machine learning algorithms of the Dreem 3S will be instrumental in reducing the human variability that is present within existing clinical workflows, allowing for more precise, accurate insights for driving forward therapy development for sleep and sleep-related disorders.”