Eran Lavi, Founder and CEO of Discover Medical Devices announce today that DMD has completed a 50 patients clinical trial with OSA diagnosed non-compliant patients.
Eran Lavi states that "In this trial we gave 50 non-compliant patients SomnuSeal masks. We have found out that the air pressure required by the SomnuSeal mask is 50% of the air pressure required by traditional masks. This is very significant for patients with heart problems because it is a known fact that cardiac output decreases as CPAP treatment air pressure rises".
Prof. Brian Glenville explains: "In a normal compliance situation, cardiac output decreases in a linear fashion as airway pressure increases. Blood flow to the heart, kidneys and intestines all show a similar fall. In decreased respiratory compliance, studies have shown that cardiac output falls at higher levels of airway pressure but this masks falls in blood flow to the heart, kidneys and intestines, even while the blood pressure appears normal. It is important to note that in clinical settings, considerable cardiovascular alterations can occur before any changes in blood pressure are noted. For patients using CPAP ventilation, some of whom will already have impaired cardiac function, reduction of airway pressure may result in significantly higher cardiac outputs, improved blood delivery to the renal and alimentary system even if there are no evident change in blood pressure. Systems that can be effective at lower pressures should offer significant benefit to the patient, especially over prolonged use".
Another case where the SomnuSeal mask is of significant benefit to OSA patients is in the case where the patients treated with CPAP suffer from Aerophobia. The higher the air pressure used in CPAP treatment, the more the Aerophobia is aggravated.
Up until now, Discover Medical has completed two clinical trials that demonstrate the safety efficacy and compliance of the SomnuSeal mask.
The SomnuSeal mask is the only mask that benefits non-compliant patients. In fact it benefits a third of non compliant OSA patients, turning 22% into compliant patients and 10% into partially compliant patients.
Thus the SomnuSeal mask is the only mask for non-compliant patients, but is it also very good for compliant and naïve patients.
According to Eran Lavi, the company is planning additional development of its proprietary SomnuSeal mask that will elevate compliance to 50% among non-compliant patients, allowing additional 7m diagnosed non-compliant patients to receive the vital CPAP treatment.