Clinical validation of a novel FOT-based APAP device for treatment of obstructive sleep apnea

Introduction: Auto-CPAP (APAP) devices have evolved as a standard therapeutic choice for treatment of obstructive sleep apnea (OSA). Valid recognition and classification of respiratory events combined with intelligent algorithms for auto-adaptive, proactive pressure regulation form the basis of therapeutic efficacy in APAP devices. In this clinical trial a novel APAP device based on the forced oscillation technique (FOT) for apnea classification was validated in patients with OSA. Methods: In a multicenter clinical trial 29 patients (22 males, age = 52 ±10 years, BMI = 32 ±5 kg/m 2 ) with OSA (apnea hypopnea index (AHI) > 15,0 /h TST and central apnea index (cAI) Results: Relative to the diagnostic polysomnogram (AHI = 37,0 ±22 /h TST, obstructive apnea index (oAI) = 18,2 ±18,8 /h TST, mixed apnea index (mAI) = 4,2 ±16,4 /h TST; hypopnea index (HI) = 12,9 ±9,2 /h TST), a significant decrease of respiratory events was observed during the treatment night (AHI = 3,6 ±4,0 /h TST, oAI = 0,7 ±1,5 /h TST, mAI = 0,2 ±0,6 /h TST; HI = 1,5 ±1,6 /h TST). The cAI did not change significantly from diagnosis (cAI = 1,5 ±2,1 /h TST) to treatment (cAI = 1,2 ±2,5 /h TST). Conclusions: Results show an effective reduction of obstructive respiratory events relative to diagnosis. No significant change in the central apnea index was observed indicating that the applied therapeutic pressure did not induce central events. Findings confirm the efficacy of the advances in event-recognition as well as pressure regulation implemented in the novel FOT-based APAP device.