Dreem 3S
Beacon Biosignals, Inc.The Dreem 3S is a wearable headband device that uses EEG electrodes and a 3D accelerometer to record brain electrical activity and movement during sleep. It applies an artificial neural network to automatically analyze and classify sleep stages, providing clinicians with detailed reports of patients' sleep patterns to aid in sleep assessment at home or in healthcare settings.
Intended Use
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment, with output of hypnograms and sleep metrics for adults aged 22 to 65 years.
Technology
The device features a wearable headband with 6 dry EEG electrodes and a 3D accelerometer to gather physiological signals. It transmits raw data to servers where an artificial neural network processes frequency spectra through recurrent and attention layers to classify sleep stages automatically every 30 seconds according to AASM standards. It includes a bone-conduction speaker for notifications and allows export of raw EDF data files.
Performance
Clinical performance was validated in a study comparing Dreem 3S automated sleep staging to expert-scored polysomnography (PSG) in 38 adults with disturbed sleep, showing high positive agreement for most sleep stages (e.g. 88.5% for wake, 83.4% for N2, 91.57% for REM). EEG data quality was sufficient for manual review with 96.6% epochs deemed scorable. Usability testing demonstrated patient tolerability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2022
8 months - 2
FDA Approval
8/18/2023
Other devices from Beacon Biosignals, Inc.
- Dreem 3S2024 • 510K
- SleepStageML2024 • 510K
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