The FDA has authorized two versions of SOMNOmedics’ forehead-applied type II home sleep test with a pulse oximeter ring. Use cases range from insomnia screening to CPAP efficacy monitoring.

Key takeaways:

• SOMNOmedics’ HomeSleepTest and HomeSleepTest REM+ are now FDA cleared as type II diagnostic aids.
• Both versions use disposable adhesive electrodes, with REM+ adding AASM-compliant EOG placement for eye movement detection.
• When paired with the OtwoFellow oximeter ring, the device records plethysmography, SpO₂, heart rate, and activity.
• The system calculates sleep stages, autonomic arousals, desaturation indices, and other metrics to assess sleep quality.

The US Food and Drug Administration has cleared two versions of a new type II home sleep test from SOMNOmedics as a diagnostic aid for detecting sleep-related breathing disorders, sleep staging, and measuring snoring levels.

Simply named HomeSleepTest, as one word, the standard version is applied using a disposable 3-button adhesive electrode on the forehead and a separate adhesive electrode on the mastoid. The other version, named HomeSleepTest REM+, is applied using four separate disposable adhesive electrodes, placing the EOG electrodes in an AASM-compliant position that improves the recording of horizontal and vertical eye movements.

With the OtwoFellow-branded pulse oximeter ring, the device records plethysmographic data, SpO2, heart rate, and activity data.

HomeSleepTest Use Cases

The HomeSleepTest calculates EEG/EOG/EMG, sleep stages, SpO₂, plethysmography, pulse rate, and snoring level. Derived parameters include autonomic arousal (based on plethysmogram of ring), oxygen desaturation index, and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters—to aid in determining sleep quality and quantity.

With a battery life of 36 hours for HomeSleepTest and 11 hours for the rechargeable ring, several nights of comparison are feasible. Use cases for the device are varied and include screening patients for insomnia or circadian rhythm disorders, as well as efficacy checks before and after starting obstructive sleep apnea therapy.

Insomnia Screening

For insomnia screening specifically, the SOMNOmedics HomeSleepTest has several useful features:

• Objective determination of sleep stages;
• Recording of EEG/EOG, EMG, continuous impedance, light, activity, position, sound (snoring);
• Detection of cortical arousals and sleep fragmentation;
• Cloud-based analysis software, AASM-compliant analysis and report templates (encrypted data transfer); and
• Ability to record multiple nights of sleep.

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