A new study published online today in the Journal of Clinical Sleep Medicine validates scoring guidelines that better enable physicians and respiratory technologists to review, verify, and interpret Itamar Medical WatchPAT sleep test automated scoring. The COMPASS 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.
“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,” says Alan Schwartz, MD, principal investigator for the study, in a release. “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, which was conducted at Johns Hopkins University, 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 body of clinical evidence about the accuracy and effectiveness of the WatchPAT in patients with central sleep apnea and chronic obstructive pulmonary disease (COPD), have also been recently published.

Key findings from a study evaluating the use of WatchPAT when enhanced with the two new features, PAT signal upstroke analysis and the Respiratory Effort Snore & Body Position Sensor, can detect central sleep apnea in adult patients by accurately measuring the apnea-hypopnea index (AHI) and central apnea-hypopnea index (AHIc), all with correlations of 0.80 or higher, as compared with in-lab PSG.

Additional findings from a study evaluating the accuracy of WatchPAT in diagnosing obstructive sleep apnea (OSA) in patients with chronic obstructive pulmonary disease include the presence of OSA and AHI as determined by WatchPAT has good agreement with PSG in COPD patients, and that WatchPAT AHI accuracy was not affected by COPD severity as measured by lung function.

“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,” says Gilad Glick, president and CEO of Itamar Medical, in a release. “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 comorbid conditions. We believe that publication of these studies will continue to raise awareness of and increase physician confidence in the benefits that WatchPAT and our digital healthcare platform provides to help them increased access to diagnosis and therapy to achieve optimal outcomes for their patients and reduce healthcare costs.”