CleveMed receives $2.3 million in funding for inpatient diagnosis of sleep disorders in cardiovascular surgery patients

Cleveland Medical Devices has announced that it has been awarded $2.3 M in NIH SBIR Phase II Continuation funding from the National Institute of Neurological Disorders and Stroke (NINDS).

The grant will fund clinical inpatient evaluation of sleep disordered breathing (SDB) in cardiac patients preoperatively. In addition to completing development of a compact, telemetry-based PSG system better suited for sleep evaluation in that specific application, the grant will fund a large clinical trial that will be conducted at the Cleveland Clinic Foundation with Dr. Nancy Foldvary-Schaefer and Dr. Roop Kaw and at Johns Hopkins University with Dr. Nancy Collop. Clinical superiority over currently used screening tools and SDB prevalence and morbidity rates in the cardiovascular surgery population will be determined.

"There is an urgent need to improve the diagnosis of sleep disordered breathing in surgical patients in order to avoid complications intraoperatively and postoperatively," said Dr. Collop.

Sleep disordered breathing includes a group of disorders, such as obstructive and central sleep apnea, that are characterized by repeated arousals from sleep as a result of a cessation in breathing, causing highly fragmented and poor quality sleep. Many studies point to a strong link between SDB and a number of disorders, particularly cardiovascular disease, and many others are finding that adverse surgical outcomes are more frequent in patients with sleep apnea, as both anesthesia and surgery exacerbate airway instability and affect homeostasis in that patient population.

"Preliminary data suggest that patients with sleep apnea may be at increased risk for postoperative complications with a greater need for intensive monitoring," said Dr. Foldvary.

The Crystal Monitor® PSG line of products was designed to make it easier for physicians to diagnose sleep disorders by making it possible to perform sleep studies not just in the traditional sleep labs, but also in a variety of non-traditional settings. "We want to pioneer the use of sleep evaluation on the ward through the use of new technology that is beneficial to patients, trusted by physicians and cost effective to hospital administrators", says Hani Kayyali CleveMed president and grant Principal Investigator.

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