Unveiling the hidden risks of CPAP device innovations and the necessity of patient-centric testing.

A 72-year-old patient had a severe sleep apnea syndrome well controlled for many years through CPAP therapy. When switching to a newer device with upgraded functions, therapy completely failed. A video recording performed by the patient's wife showed high frequency mask movements suggesting inability to maintain a therapeutic pressure with high frequency pressure fluctuations, confirmed afterwards during full night polysomnography and in a bench study. CPAP manufacturers may put on the market new devices with supposedly better algorithms that in fact may have escaped serious pre-marketing evaluation and that may jeopardize the efficacy of a well proven treatment. We suggest that better evaluations are necessary before marketing therapeutic devices, and that post-marketing assessment of unanticipated side effects should become the norm.

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