Study Validates Scoring Guidelines for WatchPAT Device

Itamar Medical Ltd., a medical technology company focused on the development and commercialization of non-invasive medical devices to aid in the diagnosis of respiratory sleep disorders, has published the results of the Compass study validating scoring guidelines that better enable physicians and respiratory technologists to review, verify and interpret WatchPAT automated scoring. The study also found that the use of those guidelines is reliable and improves agreement between WatchPAT and gold standard polysomnography (PSG)-derived sleep and breathing indices across age and gender subgroups. The study appears online in the Journal of Clinical Sleep Medicine.¹
 
“WatchPAT significantly improves workflow by automatically rendering a fully scored report. This report is generated automatically from a unique set of signals, most notably the PAT Signal, which is used to stage sleep and recognize sleep disordered breathing events without requiring any sensors on the face or head to record electroencephalogram or airflow signals,” said Alan Schwartz, MD, principal investigator for the study, which was conducted at Johns Hopkins University. “Sleep physicians are accustomed to using scoring guidelines when interpreting sleep studies. This study takes the same concept a big step further. It provides the first validated scoring guidelines for physicians and technologists using PAT-based technologies. It should help sleep physicians unfamiliar with the PAT signal build confidence in WatchPAT as they incorporate this home sleep testing device into their diagnostic armamentarium.”

The prospective, blinded, nonrandomized clinical trial study had 262 participants, who underwent WatchPAT simultaneously with PSG to develop (n=30), optimize (n=62) and validate (n=170) scoring guidelines. Sleep physicians can use these guidelines to review and edit respiratory events and sleep architecture from WatchPAT automated scoring and recordings. The study concluded that manual review of WatchPAT’s automatic scoring is reliable and improves the agreement with PSG-derived sleep and apnea/hypopnea indices. 
 
Results from two other studies, which add to the growing body of clinical evidence demonstrating the accuracy and effectiveness of the WatchPAT in patients with CSA and COPD, have also been recently published.^2,3
 
“Itamar Medical is committed to removing the obstacles that hinder accurate diagnosis and effective management of sleep apnea in the 80% of patients believed to suffer from this chronic disease and never been diagnosed,” said Gilad Glick, president and CEO of Itamar Medical. “We believe that making it easy for clinicians to interpret WatchPAT and providing them with robust clinical evidence of the accuracy and utility of WatchPAT in diverse patient populations and clinical indications is critical to driving adoption of WatchPAT. These three published studies add to the solid clinical evidence that the WatchPAT accurately diagnoses multiple forms of sleep disordered breathing across gender, age, and co-morbid conditions.”
 
References
¹ Zhang Z, Otvos T, Sanglard Sperandio L, et al. A comparison of automated and manual sleep staging and respiratory event recognition in a portable sleep diagnostic device with in-lab sleep study. J Clin sleep Med. 2020 Feb 5. doi: 10.5664/jcsm.8278. [Epub ahead of print]
² Pillar G, Berall M, Berry R, et al. Detecting central sleep apnea in adult patients using WatchPAT – a multicenter validation study. Sleep Breath. 2019 Aug 11. doi: 10.1007/s11325-019-01904-5. [Epub ahead of print]
³ Jen R, Orr JE, Li Y, et al. Accuracy of WatchPAT for the diagnosis of obstructive sleep apnea in patients with chronic obstructive pulmonary disease. COPD: Journal of Chronic Obstructive Pulmonary Disease, 17:1, 34-39, DOI: 10.1080/15412555.2019.1707789