Clinical Trials Archives

Researchers have measured and confirmed the existence of a possible link between sleep apnea and post-surgical delirium.

“The association between sleep apnea and postoperative delirium is big news because it may offer us a way to control postoperative delirium which can be devastating,” said senior author Madan Kwatra, Ph.D., a research team member  at the Duke University Medical Center.

The study findings will be published in the April 2012 issue of journal Anesthesiology.

Delirium is not a minor consequence. The condition involves an acute and fluctuating consciousness and ability to understand, and is associated with health problems and higher risk of death right after surgery. Delirium is a strong predictor of mortality even 10 years after surgery. Read the rest of this entry

Sleep Related Facts-Figures and Vital Signs

Nicholas Jackson puts the latest facts and figures from the all of the most influential medical journals; newspapers; and health, fitness, and wellness websites.

  • 5,400,000  — The approximate number of kids in the United States that have been diagnosed with ADHD, according to the Centers for Disease Control and  Prevention (CDC). Source: “ADHD More Common Among Youngest Kids in Class: Overdiagnosed?” CBS.
  • 5.5 — The percentage that diagnosis rates of ADHD have increased, on average, per year from 2003 to 2007, according to the Centers for Disease Control and Prevention (CDC). Source: “ADHD More Common Among Youngest Kids in Class: Overdiagnosed?” CBS.
  • 6 — The percentage of airline pilots who work the same shift every day, according to a new 2012 Sleep in America poll, which suggests that variable schedules lead to sleepiness which leads to slower reaction times, decreased attention, and problems processing and learning information.  Source: “One in Five Pilots Report a Serious Error Related to Sleepiness,” the Wall  Street Journal. Read the rest of this entry

Clinical Trial Offers Free HGNS Device

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.

“This study provides further validation that Provent Therapy is an effective  treatment for some OSA patients as it reduces daytime sleepiness, apnea hypopnea  index (AHI) and snoring associated with this prevalent condition,” said Meir  Kryger, M.D., of Gaylord Sleep Medicine and past president of the American  Academy of Sleep Medicine. “Patients reported wearing the device almost 90  percent of the nights, which represents very high compliance. The current gold  standard, continuous positive airway pressure (CPAP) is very effective but many  patients do not use it adequately. Provent represents an important new treatment  option for many obstructive sleep apnea patients.” Read the rest of this entry

Stimulation Therapy For Sleep Apnea Trials

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

Childhood Obstructive Sleep Apnea Syndrome

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

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