HomeSleepTest (HST, HST REM+)
Somnomedics GMBHThe HomeSleepTest (HST, HST REM+) by Somnomedics GMBH is a non-invasive, prescription device designed for home use to aid in the diagnosis of sleep disorders, including sleep-related breathing disorders. It records multiple physiological signals such as brain electrical activity (EEG), eye movements (EOG), muscle activity (EMG), oxygen saturation, heart rate, and snoring. The data is collected via frontal and mastoid electrodes and other sensors, then uploaded to a cloud platform for analysis by clinicians using specialized software. This helps physicians assess sleep quality and breathing disorders outside of hospital settings, improving patient comfort and accessibility to diagnostic testing.
Intended Use
The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. It diagnoses sleep breathing disorders, sleep stages, and snoring level using EEG and other physiological signals.
Technology
The device records nine physiological signals including EEG, EOG, EMG, snoring, activity, and head position via sensors and electrodes. Data is transferred via Bluetooth to a tablet and uploaded to a secure cloud platform for analysis with the DOMINO software, which supports manual verification and reporting by clinicians.
Performance
Clinical validation compared the HomeSleepTest with a gold standard polysomnograph (SOMNOscreen plus) in 30 adult patients, showing strong agreement (83% concordance, Cohen's kappa 0.77) in sleep stage classification and meeting acceptance criteria across multiple sleep and oxygen desaturation parameters. The device complies with ISO and IEC safety and biocompatibility standards. Software validation and cybersecurity assessments were also included.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/14/2024
8 months - 2
FDA Approval
12/8/2024
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