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BriefMEDTECH

AI Sleep Rhythm Regulator SleepTune Gets CE Certification: Closed-Loop Acoustic Stimulation Boosts Deep Sleep

Germany's Dreem releases SleepTune AI sleep regulator with real-time EEG monitoring and closed-loop acoustic stimulation, increasing deep sleep proportion by an average of 23%.

AI Sleep Rhythm Regulator SleepTune Gets CE Certification: Closed-Loop Acoustic Stimulation Boosts Deep Sleep

On July 21, 2028, German sleep technology company Dreem released the SleepTune AI sleep regulator and received EU CE Class IIa medical device certification. SleepTune is a head-worn device with 4-channel EEG sensors and bone conduction speakers that monitors users' sleep stages in real time and plays specific frequency acoustic pulses when shallow sleep is detected, guiding the brain into deep sleep.

In a multi-center clinical trial involving 1,200 subjects, SleepTune increased subjects' deep sleep proportion by an average of 23% (from a baseline of 17.2% to 21.1%) and shortened average sleep onset latency by 12 minutes. The trial also observed statistically significant improvements in subjects' next-day cognitive test performance.

Dreem's head of clinical affairs Anna Schmidt said SleepTune's primary target users are people whose sleep quality has declined due to work stress or jet lag, rather than clinical insomnia patients. The device is priced at 599 euros and is on sale in Germany, France, and the UK.