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

June 30, 2017

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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She said their findings could also have implications for cancer, against which tea has also been shown to be protective. "Since milk appears to modify the biological activities of tea ingredients, it is likely that the anti-tumour effects of tea could be affected as well. I think it is essential that we re-examine the association between tea consumption and cancer protection, to see if that is the case."

Said Dr Lorenz: "It is important to bear in mind that green tea is almost exclusively drunk without milk. So we are talking only about those countries and regions where black tea is consumed and where milk is added. We certainly don't want to dismiss the consumption of black tea: the results of our study merely attempt to encourage people to consider that, while the addition of milk may improve its taste, it may also lower its health-protective properties."

Dr Stangl said that another important lesson from their research was that it was vital in nutritional studies to exclude confounding factors as far as possible. Often, the effects of a single nutritional compound or beverage such as red wine, olive oil and so on, are analysed. But, it is difficult to assign clearly the observed effects and separate them from the surrounding food matrix (such as adding milk) that may bias results. It was therefore important to collect all data accurately and include potentially confounding factors in the analysis.

She said that the team was now in the process of comparing the effects of green and black tea on vascular function. "It's an ongoing question whether green tea, with its higher catechin content, is superior to black tea in regard to endothelial function. In addition, because of the antiatherogenic potential of tea ingredients, we want to investigate the effects of the ingredients on chronic cardiovascular processes such as the development of restenosis (re-narrowing of arteries) after catheter procedures."

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