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
Damien Leger, Maxime Elbaz, Benoît Piednoir, Amélie Carron, Joëlle Texereau, Damien Leger, Maxime Elbaz, Benoît Piednoir, Amélie Carron, Joëlle Texereau
Abstract
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.
Figures
References
- Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008;5:136–143. doi: 10.1513/pats.200709-155MG.
- Leger D, Bayon V, Laaban JP, Philip P. Impact of sleep apnea on economics. Sleep Med Rev. 2012;5:455–462. doi: 10.1016/j.smrv.2011.10.001.
- Masa JF, Corral J, Sanchez de Cos J, et al. Effectiveness of three sleep apnea management alternatives. Sleep. 2013;36:1799–1807.
- Philip P, Sagaspe P, Lagarde E, et al. Sleep disorders and accidental risk in a large group of regular registered highway drivers. Sleep Med. 2010;11:973–979. doi: 10.1016/j.sleep.2010.07.010.
- Kendzerska T, Gershon AS, Hawker G, Leung RS, Tomlinson G. Obstructive sleep apnea and risk of cardiovascular events and all-cause mortality: a decade-long historical cohort study. PLoS Med. 2014;11:e1001599. doi: 10.1371/journal.pmed.1001599.
- Gasa M, Tamisier R, Launois SH, et al. Residual sleepiness in sleep apnea patients treated by continuous positive airway pressure. J Sleep Res. 2013;22:389–397. doi: 10.1111/jsr.12039.
- Fietze I, Penzel T, Alonderis A, et al. Management of obstructive sleep apnea in Europe. Sleep Med. 2011;12:190–197. doi: 10.1016/j.sleep.2010.10.003.
- Fox N, Hirsch-Allen AJ, Goodfellow E, et al. The Impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012;35(4):477–481.
- Isetta V, Thiebaut G, Navajas D. et al. International Journal on Advances in Life Sciences, 2013; 5: (3, 4).
- Collop NA, Anderson WM, Boehlecke B, et al. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable monitoring task force of the american academy of sleep medicine. J Clin Sleep Med. 2007;3(7):737–747.
- Iber C, Ancoli-Israel S, Chesson AL, Jr, Quan SF. For the American Academy of Sleep Medicine. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications. 1. Westchester: American Academy of Sleep Medicine; 2007.
- Schwab RJ, Badr SM, Epstein LJ, et al. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013;188(5):613–620. doi: 10.1164/rccm.201307-1282ST.
Source: PubMed