St. Luke’s Sleep Medicine and Research Center is now enrolling participants in a clinical study to evaluate the safety and effectiveness of the Apnex Hypoglossal Nerve Stimulation (HGNS) System, an implantable device, to treat obstructive sleep apnea (OSA).

“Continuous positive airway pressure (CPAP), which involves a pressurized mask over the nose, is considered the ‘gold standard’ for the treatment of sleep apnea, but many people have difficulty tolerating it,” said Paula Schweitzer, PhD, St. Luke’s Sleep Medicine and Research Center director of research. “This implantable device offers a new approach for those who have not had success with CPAP or other sleep apnea treatments.”

People interested in learning if they qualify for the Apnex Clinical Study may call 888-975-3370 begin_of_the_skype_highlighting            888-975-3370     end_of_the_skype_highlighting or visit stlukes-stl.com/sleep. Qualified participants will receive the medical device and care free of charge.

A recent study by the American Psychiatric Association of Psychiatric  Services concludes a direct connection between sleep apnea and certain  psychiatric conditions. It also points out that the solutions for psychiatric  patients are just as simple as those for all individuals suffering from sleep  apnea. Companies like Rematee provide a solution that is both non-evasive and  ensures side sleeping.

Sleep apnea is a relatively common sleep disorder that causes patients to  stop breathing from 20 seconds to 40 seconds, due to a relaxed and thus  partially collapsed airway. Although it will not outright wake its victims, it  will bring them to a lighter stage of sleep, disrupting the rest and relaxation  needed by the brain, as well as other parts of the body.

Because the brain is so affected by this sleep disorder, much research is  being done as to how it relates to psychiatric conditions.  Studies are showing  that the effects of sleep apnea on certain mental conditions, including that of  Alzheimer’s disease, are actually quite prominent. Read the rest of this entry

The safety and effectiveness of sleep apnea equipment will be examined,evaluated, and determined with the help of a research study conducted by Winston-Salem Company.

Winston-Salem announced that  it has received approval to begin a clinical study to evaluate the  safety and effectiveness of the Apnex hypoglossal Nerve Stimulation (HGNS) System. The device is used to treat obstructive sleep apnea (OSA).

PMG will be one of the first medical centers in the country to participate in this study. “Many people who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a new approach to the treatment of OSA. This study will help us  further understand what role this device could have in treating the millions of people who suffer from OSA,” said the study’s co-principal investigator. Read the rest of this entry

Apnex Medical, Inc., has received CE Mark approval for its Hypoglossal Nerve Stimulation (HGNS®) System for use by people who suffer from obstructive sleep apnea (OSA). The system was approved for sale in Europe based on the positive results of two clinical studies conducted in the United States and Australia. In those studies, the majority of patients demonstrated a significant reduction in their obstructive sleep apnea as well as substantial improvements in the quality of their sleep, quality of life, and overall health.

“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnea and is a key milestone for our company,” said Chas McKhann, Apnex Medical President and CEO. Read the rest of this entry

Ventus Medical  revealed the results of a large, long-term study of its proprietary Provent® Sleep Apnea Therapy, an innovative, non-invasive treatment for  obstructive sleep apnea (OSA), were published in the November 2011 issue of the  Journal of Clinical Sleep Medicine, an official publication of the American Academy of Sleep Medicine.

The University Hospitals Case Medical Center is conducting  research study and clinical trials  for evaluating effectiveness of a new implantable device to treat sleep apnea.

The study is aimed to evaluate an electronic device designed to deliver mild stimulation to the main nerve of the tongue — the hypoglossal nerve — on each breathing cycle during sleep.

This stimulation is intended to restore tone to the muscles that control the base of the tongue, which prevent the tongue from collapsing and obstructing the airway during sleep.

Sleep apnea obstruction may not be the only cause for loud snoring but it does affects sleep that is not refreshing. At the same time sleep apnea equally causes daytime sleepiness and a reduced quality of life. Other disorders associated with sleep apnea include development of high blood pressure, as well as cardiovascular diseases, stroke and diabetes. Read the rest of this entry

The clinical syndrome of obstructive sleep apnea (OSAS) in children is a distinct, yet somewhat overlapping disorder with the condition that occurs in adults, such that the clinical manifestations, polysomnographic findings, diagnostic criteria and treatment approaches need to be considered in an age-specific manner. Childhood OSAS has now become widely recognized as a frequent disorder and as a major public health problem. Pediatric OSAS, particularly when obesity is concurrently present, is associated with substantial end-organ morbidities and increased healthcare utilization. Although adenotonsillectomy (T&A) remains the first line of treatment, evidence in recent years suggests that the outcomes of this surgical procedure may not be as favorable as expected, such that post-T&A polysomnographic evaluation may be needed, especially in high-risk patient groups. In addition, incorporation of nonsurgical approaches for milder forms of the disorder and for residual OSAS after T&A is now being investigated. Read the rest of this entry

The benefits of continuous positive airway pressure machines (CPAP) for patients with obstructive sleep apnea (OSA) are quickly reversed when the therapy is withdrawn, according to Swiss research. The findings appear online in the articles-in-press section of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

“In patients with obstructive sleep apnea who are established on CPAP treatment, withdrawal of the therapy is associated with a rapid recurrence of OSA and sleepiness within a few days” said Malcolm Kohler, MD, senior consultant at the Sleep Disorders Centre and Pulmonary Division of the University Hospital in Zurich. “After 14 days of CPAP withdrawal, OSA patients experienced considerable increases in heart rate and blood pressure as well as a deterioration in vascular function.” Read the rest of this entry

SleepApneaDisorder/[ Press Release ]/ ST. PAUL, Minn., Aug. 2, 2011 /- Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA). Data from this clinical study are intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.“Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA,” said the study’s co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women’s Hospital. Read the rest of this entry

What looks like a pacemaker for the heart, may be the ticket for a good night’s sleep.  An experimental treatment for Obstructive Sleep Apnea is being tested at the Medical University of South Carolina, where doctors have performed one of only six surgeries in the United States, as part of a trial monitored by the Food and Drug Administration. The experimental treatment works by stimulating muscles to keep the airway from closing off.

Five percent of men and three percent of women in this country suffer Obstructive Sleep Apnea.  The numbers dramatically increase as people age.  People with Obstructive Sleep Apnea often snore loudly, don’t sleep well at night and feel tired during the day.  It can lead to depression, irritability and memory troubles. But it also has the long term risk of stroke, heart disease, high blood pressure and increased risk of automobile accidents.” Read the rest of this entry

DeVilbiss Healthcare recently sponsored a randomized, double-blind, crossover clinical study which confirmed the effectiveness of DeVilbiss SmartFlex Technology, a new exhalation pressure relief solution to enhance patient comfort.

Positive Airway Pressure (PAP) represents the gold standard in the treatment of Obstructive Sleep Apnea (OSA). In recent years, pressure modification has become accepted as an important feature improving patients’ comfort and compliance. However, there has been some speculation that excessive pressure relief may compromise the effectiveness of therapy.

The study confirmed SmartFlex Technology to be equally effective to standard Auto-PAP therapy in that respiratory events and oxygen saturation during sleep were normalized among the participants. In addition, treatment with SmartFlex showed a lower leak rate, which likely contributes to the greater subject acceptance rates. As expected, both modalities resulted in improved daytime alertness, but improved daytime energy levels, ability to relax and nocturnal sleep were also demonstrated with SmartFlex Technology. Read the rest of this entry

Inspire Medical Systems, the leading developer of neurostimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today The STAR trial (Stimulation Therapy for Apnea Reduction), evaluating both the safety and effectiveness of Inspire™ Upper Airway Stimulation (UAS) therapy, is currently underway at 9 leading medical centers across the United States and at 4 sites in Europe. In addition, several OSA patients have already been implanted with Inspire therapy in The STAR trial. Read the rest of this entry

NeuroTrials Research, an independent research organization in Atlanta devoted to investigational drug, medical device, consumer research and diagnostic testing, has been selected to conduct two new clinical research studies of an investigational sleep medication on the breathing function of participants with Chronic Obstructive Pulmonary Disorder (COPD) or Obstructive Sleep Apnea (OSA).

Nationally recognized physicians and researchers founded NeuroTrials over a decade ago. NeuroTrials continues to attract important early phase- phase IV studies that impact the health and welfare of residents in Atlanta and nationwide. Over 24 million Americans have been diagnosed with COPD and as many as 1 in 3 American men suffer from OSA. Read the rest of this entry

Excessive daytime sleepiness (EDS) is a major but not universally present feature of obstructive sleep apnea syndrome (OSAS). The latter has been associated with glucose dysmetabolism and insulin resistance. The aim of this study was to examine the role of EDS by investigating potential differences between somnolent and non-somnolent OSAS patients in glucose metabolism, insulin resistance, and levels of cardiovascular risk factors.

Methods Included were 25 newly diagnosed otherwise healthy OSAS patients, reporting EDS and 25 age- and BMI-matched, non-somnolent OSAS patients, who served as controls. Fasting glucose and insulin levels, as well as homeostatic model assessment of insulin resistance (HOMAIR) index, levels of hs-CRP, and lipidemic profile were measured. Read the rest of this entry