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 continuous positive airway pressure 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. Continuous positive airway pressure therapy manufacturers may put on the market new devices with supposedly better algorithms that in fact may have escaped serious premarketing 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 postmarketing assessment of unanticipated side effects should become the norm.

Mwenge GB, Liistro G, Smetcoren C, Debaille C. Unveiling the hidden risks of CPAP device innovations and the necessity of patient-centric testing. J Clin Sleep Med. 2025;21(2):421-425.