First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic

Respiratory Sleep Disorder specialist, Itamar Medical Ltd. has announced publication of results of the COMPASS study. The upshot sees validated scoring guidelines that better enable physicians and respiratory technologists to review, verify and interpret WatchPAT automated scoring.

Background

Itamar Medical develops and commercializes non-invasive medical devices to aid in the diagnosis of respiratory sleep disorders. Its COMPASS prospective, blinded, nonrandomized clinical trial study had 262 participants, who underwent WatchPAT simultaneously with polysomnography (PSG) to develop (n=30), optimize (n=62) and validate (n=170) scoring guidelines. The idea is to enable sleep physicians to 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. The study appears online in the Journal of Clinical Sleep Medicine.1

Investigator comments

“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.”

Company comments

“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 Chief Executive Officer 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. 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.”

Source: Itamar Medical, Ltd.

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