NovaSom Diagnostic System approved for diagnostic evaluation of adults with OSA

Jan 29 2010

Some 18-20 million Americans are at risk for Obstructive Sleep Apnea (OSA) and of those, only 5 to 10 percent have been diagnosed.  Studies prove that fatality is a major risk of undiagnosed and untreated OSA; however, once detected, OSA can be readily and successfully treated.

Historically, OSA diagnosis has required an overnight stay in a sleep lab, with a technician directly monitoring a patient's breathing.  Many who suspect they suffer from OSA are unwilling to undergo such testing or have a difficult time reaching a state of natural sleep in a lab setting – resulting in variable or inconclusive test results.

As an alternative, Medicare, a growing number of insurance plans, and other medical organizations have recently approved the use of Home Sleep Tests (HST) as the clinically-accurate and cost-effective way to improve patients' access to diagnosis and potentially life-saving treatment.  The NovaSom^® Diagnostic System, from Sleep Solutions, Inc., is the first nationally available, full-service home testing system that was cleared by the U.S. Food and Drug Administration for diagnostic evaluation of adults with possible sleep apnea.

Once prescribed by a physician, NovaSom is delivered directly to the patient's home. The patient uses the device for three consecutive nights, collecting sleep data such as respiratory events (apneas and hypopneas), snoring intensity, blood oxygen saturation, pulse rate and respiratory effort.

The system itself consists of a compact bedside console and three sensors that are easily applied by the patient.  Like a GPS system, the NovaSom test uses voice prompts to talk the patient through the set-up and operation.

During sleep, NovaSom utilizes patented audio digital signal processing (DSP) technology to sense, analyze and process a patient's respiratory sounds and convert the sounds into airflow volume.  In fact, the NovaSom airflow sensor has uniquely demonstrated linear equivalence to the industry gold standard for airflow measurement.

After three nights of use, the NovaSom Diagnostic System is returned via prepaid overnight shipping to Sleep Solutions, where the patient's test data are analyzed, downloaded and sent to a qualified physician for interpretation and diagnosis.  Study results are delivered to the referring physician within 48 hours of receipt from the patient.  This allows for rapid and accurate diagnosis of OSA and appropriate treatment recommendations.  In clinical studies, diagnostic accuracy and predictability of the NovaSom System were proven to be comparable to in-lab Polysomnography (PSG) for diagnosis of OSA, at a fraction of the cost.  

Following a diagnosis of OSA, there are a variety of treatment options available to patients, based on the severity and cause of the disorder. The most commonly prescribed and effective first-line therapy is Continuous Positive Airway Pressure (CPAP), in which a continuous stream of air pressure is delivered through the nasal passages to prevent airway collapse. Other treatment methods include dental appliances or surgical options to expand the air passage, or for mild OSA, behavioral modification.  Each patient's treatment plan is determined by their physician.