September 2009 Archives

The Sleep Center at Baylor University Medical Center at Dallas recently received accreditation from the American Academy of Sleep Medicine. The center at Baylor Dallas is one of only two dozen accredited centers in North Texas.

"Accreditation provides formal recognition of our commitment to quality scientific research and care for patients suffering from sleep disorders," said David L. Luterman, M.D., sleep medicine physician and pulmonologist on the medical staff at Baylor Dallas and director of the Sleep Center at Baylor Dallas. "We are proud to be an accredited resource for the community."

The Sleep Center at Baylor Dallas offers comprehensive care for more than 80 sleep disorders and other conditions, including sleep apnea, restless legs syndrome, insomnia, daytime sleepiness, and narcolepsy.

"Sleep disorders can profoundly affect a person's physical and emotional health," said Dr. Luterman. "Our sleep center designs a personalized diagnostic and treatment program to meet each patient's needs."

To receive a five-year accreditation, a sleep center must meet or exceed all standards for professional health care as designated by the American Academy of Sleep Medicine. The accreditation process involves detailed inspection of a center's facility and staff, including an evaluation of testing procedures, patient contacts and physician training. Additionally, the facility's goals must be clearly stated and include plans for positively affecting the quality of medical care in the community it serves.

SOURCE Baylor University Medical Center at Dallas

Cephalon, Inc. (Nasdaq: CEPH) today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder.

The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe. These data were presented earlier this year at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies.

About NUVIGIL

NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.

The company's proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1-800-896-5855.

SOURCE Cephalon, Inc.

Sit 'n Sleep, the mattress superstore dedicated to providing a good night's sleep to millions of Southern Californians, is looking for L.A.'s worst mattress. Today, the company launched L.A.'s Worst Mattress Contest in which five lucky Southern Californians with the worst mattresses in the region will win a new, luxury mattress from Sit 'n Sleep and a chance to win $100,000.

Starting this week, contest entrants are invited to create and submit inspiring videos detailing just why their mattress is the very worst in town. Uploaded to www.worstmattress.com, entries will be judged both on creativity and the criteria used to determine whether that old mattress needs to be replaced.

And just what is that criteria?

• TEAR & WEAR: How beat up is your mattress? Does it look like it was dropped off the 5 Freeway during rush hour and hit by a semi truck? Is it discolored, ripped or are the box springs about to jump out and injure someone?
• OLDEST: Fess up, how old is that mattress? Was it purchased in a time before the Internet, cordless phones or even microwaves? Does it look like over 10,000 nights of bad sleep have finally caught up with it?
• SAG: Does your mattress look like a bowling ball has been sleeping in its center for the last decade? If so, it's time to re-think your sleeping situation.
• STAINS: Does your mattress bear the evidence of years of bedroom activity? If so, it's time to TOSS!
  

"I want to see those dirty, beat up mattresses, and get a good look at those sags and stains!" said Larry Miller, founder, president and CEO of Sit 'n Sleep. "People don't understand that, after eight years, mattresses double in weight, are filled with bed bugs, and are bad for your health. It's time to get rid of the major embarrassment below your bedspread and start getting those zz's back."

How the contest works:

• Visit the Worst Mattress website for details
• Submit a video that, in 90 seconds or less, explains why your mattress is the worst in L.A. - remember, have fun and be creative!
• Entries are due by October 30, 2009
• On November 2, 2009, five winning videos will be announced and each will win a free luxury mattress.
• The grand prize winner receives a Kingsdown 800 mattress worth approximately $5,000.00. Four other category winners receive luxury mattresses ranging in value from $1,500 to $3,900
• On Saturday, November 21, 2009 the five lucky winners will be invited to Sit 'n Sleep's Culver City Superstore to participate in a drawing with a chance to win $100,000*
  

For more contest rules and details or to submit a video, log on to: www.worstmattress.com

SOURCE Sit 'n Sleep

Here are highlights from the September issue of Mayo Clinic Health Letter. You may cite this publication as often as you wish. Reprinting is allowed for a fee. Mayo Clinic Health Letter attribution is required. Include the following subscription information as your editorial policies permit: Visit www.HealthLetter.MayoClinic.com or call toll-free for subscription information, 800-333-9037, extension 9771.

Ways to Quiet Ordinary Snoring

ROCHESTER, Minn. -- Ordinary, loud snoring doesn't seem to be harmful, according to the September issue of Mayo Clinic Health Letter. But snorers still may want to seek treatment to stop snoring, reduce embarrassment and improve sleep for themselves and their bed partner.

Snoring is caused by relaxed and sagging tissues. As sleep deepens, the tongue relaxes, as do the soft tissues of the throat and the roof of the mouth (soft palate). The tissues can sag into the airway, causing it to narrow. As air is inhaled or exhaled through the narrowed opening, the relaxed tissues of the soft palate vibrate. The result is snoring. Though most snoring is harmless, snorers should consult a doctor to rule out sleep apnea, a serious health concern where breathing stops during sleep.

For ordinary snoring, a doctor will likely discuss conservative treatment options first. Assistive devices or, as a last resort, surgery, can help reduce snoring. Mayo Clinic Health Letter covers these treatment approaches:

Lose weight: Extra bulk narrows airways, contributing to snoring.

Avoid alcohol: Alcohol consumption can cause excessive muscle relaxation. Avoiding alcohol for at least four hours before bedtime may help.

Relieve nasal obstruction: Adhesive nasal strips (Breathe Right, others) or corticosteroid nasal sprays can help reduce nasal obstruction that can contribute to snoring.

Change sleep positions: In back sleepers, the tongue can sag and narrow the airway during sleep. A doctor can suggest techniques to learn to sleep comfortably in other positions.

Stop smoking: Smoking is associated with an increased risk of snoring. People who stop have a lower rate of snoring.

Try assistive devices: The most effective treatment for snoring is a continuous positive airway pressure (CPAP) machine. It delivers pressurized air through a mask, keeping the upper airway open during sleep. Some people have difficulty wearing a mask at night. An oral appliance from a specially trained dentist or orthodontist can help keep the throat open, too, and may be less obtrusive than a CPAP machine.

Consider surgery: Several surgical procedures can help reduce snoring, either by cutting away excess mouth and throat tissue or by stiffening tissues of the soft palate to prevent vibration and sagging. Surgery is considered a last resort because it can cause side effects and complications. Typically, there's only a 50 percent chance that snoring will improve over the long term.

Let's Not Repeat That Pain: Tips to Reduce Risk of Kidney Stones

ROCHESTER, Minn. -- Passing kidney stones can be an extremely painful process that no one wants to repeat. But patients who have experienced kidney stones have a 50 percent chance of recurrence within 10 years. The September issue of Mayo Clinic Health Letter covers how kidney stones are formed, treatment options and ways to reduce the risk of a repeat.

Kidney stones are made up of crystal-forming minerals in the urine. Normal urine contains substances that inhibit crystal formation. However, if urine is too concentrated or if the crystal-preventing compounds aren't working properly, crystals may gradually accumulate and grow to form one or more kidney stones.

Most kidney stones pass naturally through the ureters (tubes that connect the kidney to the bladder), through the bladder and then out in the urine. Passing a kidney stone may take hours or weeks. Most often, the process takes seven to 14 days. Small stones may not be a big bother. Larger ones can cause extreme pain, typically on the side and the back, just below the rib cage and radiating to the lower abdomen and groin. There are a variety of treatment options, from pain management to surgical removal of the stone.

Once the stone has passed, the focus switches to prevention. Prevention strategies depend somewhat on the composition of kidney stones. About 70 percent are formed primarily of calcium oxalate. Others are formed mainly from calcium phosphate, uric acid or struvite stones. Recommendations for prevention of kidney stones in most people may include:

Drink enough fluid: Drinking at least 12 cups of fluid -- preferably water -- a day is the most basic way to prevent kidney stones. The fluid dilutes the urine and decreases the risk of crystal formation.

Limit meat intake: Consuming more than 6 to 8 ounces of meat daily can increase calcium and uric acid in the urine, increasing the acidity of urine and reducing the chemicals that inhibit crystal formation.

Get adequate calcium: Meeting daily calcium intake recommendations based on age reduces the risk of kidney stone development, probably because calcium binds to oxalate in the gut, reducing oxalate levels in the urine.

Avoid excess vitamin D: Often consumed with calcium to help absorption, vitamin D may raise the risk of developing calcium-based stones. Vitamin D has many health benefits, but for those at risk of kidney stones, limiting vitamin D consumption to age-specific recommended daily limits may be advised.

Consider food choices: Limiting intake of oxalate-containing foods -- such as spinach, beets, chocolate, peanuts, potatoes and many other foods -- is an important preventive strategy for those with calcium oxalate stones who also have conditions that affect the small bowel, such as Crohn's disease. For those who don't have digestive conditions or high urine oxalate levels, the benefits of diet changes are unclear. Because the diet is very difficult to follow, Mayo Clinic experts don't emphasize this strategy.

Vitamin D: Many Benefits; Optimal Dose Uncertain

ROCHESTER, Minn. -- Vitamin D appears to boost health from head to toe, according to the September issue of Mayo Clinic Health Letter. But, so far, there's no consensus on what level of vitamin D is optimal for good health.

Recent reports on vitamin D suggest that it offers many benefits, especially for older adults. Findings point to improved balance, reduction in the risk of bone fractures, and better thinking skills such as planning, organizing and abstract thinking. Low levels of vitamin D are associated with diabetes, cardiovascular disease, multiple sclerosis and other autoimmune disorders, infections such as tuberculosis, and periodontal disease. Low vitamin D levels also may affect certain cancers, including colon, breast and prostate cancers.

Vitamin D is the only vitamin that the body can manufacture itself. The only requirement is sunshine, specifically ultraviolet B rays. About 10 to 15 minutes of exposure two to three times a week during nonpeak sun hours is considered adequate. But the sunshine approach doesn't work for everyone. With age, the body is less efficient at processing vitamin D. Other barriers are darker skin and living in northern climates. Using sunscreen -- still recommended to prevent skin cancer -- also reduces absorption of ultraviolet B rays.

Food sources are usually an excellent way to obtain vitamins, but choices are limited for vitamin D. Rich sources are fatty fish, fish-liver oils, liver and egg yolks. Milk fortified with vitamin D is another option.

With limited food choices, consumers may opt to rely on vitamin D supplements. The current daily recommended dose of vitamin D for adults 50 and older is 400 to 600 international units (IU). But many researchers believe that a higher amount is warranted because of the many health benefits. The National Osteoporosis Foundation recommends a daily intake of 800 to 1,000 IU per day for adults over age 50. The upper daily limit considered safe for use is 2,000 IU per day, but there's debate about this level. Very large doses of vitamin D taken over time can cause ill effects, including nausea, vomiting, poor appetite, constipation, weakness and weight loss.

Source: Mayo Clinic

In a new online survey, eighty-five percent of people who experience diabetic nerve pain said that their pain was one of the top three most bothersome complications of their diabetes. Despite the fact that people with diabetic nerve pain recognize the condition's impact on their lives and eighty-four percent of those surveyed said they have discussed the condition with a healthcare provider, just slightly less than half of respondents (49 percent)( )were treating their pain. The survey was fielded as part of a new educational campaign, "Take the Next Step," which is designed to help people with diabetes recognize the symptoms of painful diabetic peripheral neuropathy (pDPN) and proactively talk to their healthcare professional about incorporating the treatment of pDPN into their overall diabetes care, which may include blood sugar control, diet, pain management, exercise or other changes in lifestyle. The initiative is supported through a sponsorship by Pfizer Inc.

Taking Control of Your Diabetes (TCOYD), a leading non-profit organization dedicated to educating people about diabetes, and Kim Lyons, personal trainer and nutritionist featured on NBC's hit show, "The Biggest Loser," are participating in this campaign to raise awareness of pDPN, one of the most common and debilitating complications of diabetes. "Take the Next Step" features an activity program developed by Lyons to demonstrate activities that are appropriate for people with diabetes and help people with pDPN understand how increasing their activity level can help them control their pain. For more information, including Kim Lyons' activity program and tips and tools to help people with diabetes discuss pDPN with their physician, visit www.diabetespainhelp.com.

"Optimal blood sugar control has been shown to prevent the onset and delay the progression of pDPN and ease its symptoms," said Steven Edelman, MD, Founder and Director of the not-for-profit Taking Control of Your Diabetes and Professor of Medicine, University of California at San Diego. "Given the debilitating impact of pDPN, such as on a person's ability to be physically active and to fall asleep at night, treating the pain can really make a difference for these patients and help them get back to normal daily activities which in turn can help them better manage their diabetes."

Survey Shows pDPN Can Impact Lifestyle, Yet Many Unaware of Treatment Options

Of the people surveyed, almost two-thirds (64 percent) said that their nerve pain interfered with the daily activities that matter to them. The most common activities that respondents said were impacted by their pain were exercising (76 percent), falling asleep (71 percent) and spending time with or caring for family (68 percent). Of the more than half of those surveyed who were not being treated (51 percent), less than a third (32 percent) were aware of treatments that are approved to treat the condition.

Currently, nearly 24 million Americans suffer from diabetes. Approximately 20 percent of people with diabetes experience painful diabetic peripheral neuropathy, most commonly caused by poorly controlled blood sugar levels that result in nerve damage over time. Symptoms of pDPN may include burning, throbbing or painful tingling in the feet or hands. The pain associated with the condition can become extremely debilitating, affecting patients' everyday activities such as the motivation needed to exercise and be active and the ability to fall asleep. Difficulty maintaining an active lifestyle can hamper patients' ability to control their weight, an important key to diabetes management. Treatment guidelines point to the unique nature of pDPN and the need for specialized treatment, which can include prescription treatment for the pain.( )

"I was motivated to be a part of this campaign because I've seen the benefits of activity for people who suffer from pDPN," said Kim Lyons. "I know that for people with this kind of pain, engaging in physical activity might seem daunting at first, but people will be amazed to see that taking small steps towards increasing activity level can make a big difference."

Prevention, Early Diagnosis and Aggressive Treatment Are Critical

People with diabetes can develop nerve pain at any time, but the risk is greater the longer a person has suffered from diabetes, with the highest rates among those who have had the condition for at least 25 years. In the early stages of nerve damage, some people have no symptoms, or may have numbness or tingling in the feet. These symptoms can be mild at first and because nerve damage can occur over several years, these cases may go unnoticed until the nerve damage progresses and becomes painful, sometimes leading to painful diabetic peripheral neuropathy.

A number of prescription medications are approved by the U.S. Food and Drug Administration (FDA) to help relieve the specific symptoms of pDPN. These medications can play an important role in helping to reduce the pain associated with this condition. Over-the-counter pain medicines such as acetaminophen and ibuprofen are frequently used, but have not been specifically approved by the FDA to treat painful diabetic peripheral neuropathy.

About the Survey

The survey was conducted online by Impulse Research among 553 men and women, 18 and older who have either type I or II diabetes and are suffering from diabetic nerve pain in the United States, to assess the impact of nerve pain on their lives. The research was conducted in July 2009. The maximum expected sample error for a simple random sample of this size is +/- 3 percentage points. The survey was commissioned on behalf of Taking Control of Your Diabetes, and sponsored by Pfizer.

About the "Take the Next Step" Campaign

The "Take the Next Step" program is designed to help people with diabetes better understand and manage painful diabetic peripheral neuropathy (pDPN), a complication of the disease that can have a debilitating impact on daily activities.

Taking Control of Your Diabetes (TCOYD), a leading non-profit organization dedicated to educating people about diabetes, and Kim Lyons, personal trainer featured on NBC's hit show, "The Biggest Loser," are participating in this campaign to raise awareness of pDPN, one of the most common and debilitating complications of diabetes. The Take the Next Step campaign features a customized motivational program, developed by Lyons, which helps people with pDPN understand how to raise their activity level and better manage daily activities. Ms. Lyons will be traveling to a series of TCOYD health conferences this fall to share her activity program with conference attendees.

The "Take the Next Step" campaign is sponsored by Pfizer Inc.

SOURCE Taking Control of Your Diabetes

They're BAA-AACK! Thirty years after bed bugs were believed to be exterminated nationwide, the teeny, insidious bloodsuckers--which feast on sleeping humans--are making a comeback of epidemic proportions.

They're being spotted in hotels from coast to coast. And not just the expected "fleabag" motels, but posh resorts and upscale chains. In a recent study of 700 mid-priced hotels, 25% were found to host uninvited guests. That gives travelers a 1-in-4 chance of bunking down with some unexpected roomies.

If awakened with red, itchy welts and irritated skin, one has been punked, bed-bug style. Some people even experience allergic reactions.

So, what are thoroughly creeped-out travelers to do? They can arm themselves with Rest Easy, an all-natural spray that keeps bed bugs at bay. Made from time-honored essential oils (cinnamon, lemongrass, clove, and mint), it's people-safe, earth-friendly, and even smells of minty goodness.

Good to know: the presence of cimex lectularius, aka the common bed bug, has nothing to do with cleanliness and everything to do with a transient population. Formerly wiped out in the U.S. by the now-banned pesticide DDT, bed bugs continued to flourish in other parts of the world. As global travel increased, they've hitchhiked their way back in on airplanes, luggage, and yes, travelers.

Found wherever people come and go--like hotel rooms, airports, and dorms--the 1/4" inch long nocturnal pests hide in furniture seams, box springs, and even tiny floor cracks, patiently awaiting a host (they can live without eating for up to a year).

The solution: spray Rest Easy around a hotel room upon arrival. It will kill some of them outright, and keep the rest deep in their hidey-holes. Luggage must be sprayed, too, because that's their ticket out.

Speaking of luggage, Rest Easy comes in a 2-ounce spray bottle that's carry-on friendly and available at stores like Bed, Bath & Beyond. You can buy it online at www.resteasykillsbedbugs.com, where it's also sold in larger quantities for home use.

Bedbugs are everywhere, so Rest Easy is perfect for wherever people travel, even fancy Manhattan hotels. In 2006, New York City received more than 4,500 bed bug complaints. . .which, come to think of it, may be why it's called the city that never sleeps.

SOURCE www.resteasykillsbedbugs.com

Embla(R) and Covidien have entered into a definitive agreement under which Embla will acquire Covidien's Sleep Diagnostic business. This includes the sleep diagnostic products sold under the Sandman(TM) brand name. Financial terms of the transaction were not disclosed. Completion of the sale is subject to customary closing conditions.

The combined entity will form the world's largest company to focus entirely on sleep diagnostics, with close to 1700 customers in North America and about 2500 worldwide. Embla offers market leading sleep diagnostic products, support and service.

Both Sandman and Embla have leading brand names in North America where it is estimated that over 40 million people suffer from some form of sleep disorder. Up to seventy percent of patients who have suffered a stroke and sixty percent of congestive heart failure patients also suffer from sleep disordered breathing.

"You can't open a newspaper or magazine today without seeing something about sleep. We know it impacts every aspect of our lives and this acquisition puts us at the forefront of the industry," said David Baker, President and CEO of Embla Systems.

Embla's global headquarters is based in Colorado, and the company has a significant Research & Development and Technical Support presence in their Ottawa, Canada office. The Covidien Sandman Sleep Diagnostic business is also headquartered in Ottawa, Canada.

About Embla Systems

Embla is the leader in the global sleep diagnostic market, creating medical solutions for sleep professionals and delivering value through innovative products and service excellence. The privately held company manufactures, distributes and services its products in over 65 countries. Embla has 120 employees worldwide with offices in Broomfield, CO; Buffalo, NY; Ottawa, Canada; Amsterdam; Netherlands; and Munich, Germany.

Please visit www.embla.com and www.sandmansleep.com to learn more about our business or www.closertoourcustomers.com to learn more about this transition.

Source: Embla Systems