Evaluation of the add-on NOWAPI ? medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea

摘要

Background Optimizing the measurement of Continuous Positive Airway Pressure (CPAP) compliance and treatment efficacy is paramount for patients with obstructive sleep apnea syndrome (OSAS). Compliance knowledge is currently based on data coming from CPAP machines; however algorithms and measured parameters vary from one machine to another. This study was conducted to clinically evaluate a novel device, NOWAPI?, designed to assess compliance remotely in conjunction with any CPAP machine. NOWAPI? was tested against polygraphy, the gold standard for the measurement of CPAP treatment duration and residual apnea-hypopnea index (AHI). Methods Single group assignment, open label, non-randomized. Sleep laboratory setting. 22 adult patients with OSAS treated by CPAP were included. Recordings were performed during one night while the patient was treated with his/her usual CPAP and interface. NOWAPI? data were collected electronically and compared to data acquisition and visual scoring using an EMBLETTA? GOLD polygraph. Statistics were only descriptive. Results Recordings were performed with six different CPAP machines and three different interfaces (full facemask, nasal pillow, nasal mask). The median [Q1; Q3] absolute difference in CPAP treatment duration between NOWAPI? and polygraphy was of 1.0?min [0.0; 12.0], corresponding to a relative difference of 0.21?% [0.0; 2.2] (Per Protocol data set, n?=?20). NOWAPI? tended to underestimate residual AHI in a magnitude of two events per hour as compared to polygraphy. The device was well tolerated and the patient satisfaction was good. Conclusions This clinical study confirmed prior bench tests, showing that NOWAPI? estimate of CPAP treatment duration was clinically acceptable and in agreement with polygraphy. Although a limited number of OSAS patients treated by CPAP were included, relevant findings for the device improvement were identified. Trial Registration ClinicalTrials.gov identifier: NCT01441622. The study was funded by Air Liquide HealthCare