Glidewell Dental Oasys Hinge Appliance (PDAC Approved)

Glidewell Dental has released a new mandibular advancement device, the Oasys Hinge Appliance. This oral sleep appliance is Medicare and PDAC (Pricing, Data Analysis and Coding) cleared under code E0486 to treat patients with mild to moderate obstructive sleep apnea (OSA).

“Snoring is a warning sign that should not be ignored,” says Randy Clare, director of brand and product management at Glidewell Dental, in a release. “An estimated 50% of US adults snore and 30 percent of people are habitual snorers. In addition, adults over the age of 65 are at an increased risk of obstructive sleep apnea, which can be very serious if left untreated. Two common symptoms of OSA include loud, chronic snoring and daytime sleepiness.”

The Oasys Hinge Appliance is designed to gently shift the lower jaw forward during sleep, which activates the airway muscles and ligaments to prevent the airway from collapsing. The device is custom-made for each patient. It’s micro-adjustable (0.25 mm increments), with up to 10 mm of advancement based on the patient’s needs. The telescope-style hinge allows for natural jaw movement and can be adjusted chairside or at home. Patients with Medicare insurance qualify for reimbursement of their oral appliance, making it easy and affordable to get treated.

“Oral appliance therapy is a simple and effective method for achieving a more restful night’s sleep, resulting in renewed energy during the day,” says Clare. “As dentists welcome more integrative solutions for treating patients, the Oasys Hinge Appliance will become the go-to sleep device to prevent snoring and obstructive sleep apnea.”

from Sleep Review…

More Cancer Cases Seen Among Women with Sleep Apnea Than in Men and in People Without OSA

Women with severe sleep apnea appear to be at an elevated risk of getting cancer, a study shows. No causal relationship is demonstrated, but the link between nocturnal hypoxia in women and higher cancer risk is still clear.

“It’s reasonable to assume that sleep apnea is a risk factor for cancer, or that both conditions have common risk factors, such as overweight. On the other hand, it is less likely that cancer leads to sleep apnea,” says Ludger Grote, adjunct professor and chief physician in sleep medicine, and the last author of the current study, in a release.

The research, published in the European Respiratory Journal, is based on analyses of registry data, collected in the European database ESADA, on a total of some 20,000 adult patients with obstructive sleep apnea (OSA). About 2% of them also had a cancer diagnosis.

As expected, advanced age was associated with elevated cancer risk, but adjusting the data for age, gender, body mass index (BMI), smoking, and alcohol consumption nevertheless showed a possible link between intermittent hypoxia at night and higher cancer prevalence. The connection applied mainly to women and was weaker in men.

“Our results indicate a cancer risk that’s elevated two- to three-fold among women with pronounced sleep apnea. It’s impossible to say for sure what causes underlie the association between sleep apnea and cancer, but the indication means we need to study it in more depth,” says Grote, who is also a senior consultant and head of medicine at the Department of Sleep Medicine at Sahlgrenska University Hospital.

“The condition of sleep apnea is well known to the general public and associated with snoring, daytime fatigue, and elevated risk of cardiovascular disease, especially in men. Our research paves the way for a new view—that sleep apnea may possibly be connected with increased cancer risk, especially in women,” Grote says.

Previous studies have shown that, more often than others, people with sleep apnea have a cancer diagnosis in their medical history. Research in this area is expanding, while the gender aspects have hardly been explored.

“Above all, the focus has

Have Snoring…Will Treat It

There is no gold standard treatment for snoring—yet—but clinicians and patients have a growing menu of options that can cover most of its causes.

While occasional snoring is a nuisance, chronic snoring can have serious effects on sleep, relationships, and cardiac health—even if not tied to sleep apnea.

Research led by Per Stal, associate professor and research leader at the Department of Integrative Medical Biology at Sweden’s Umeå University, has identified that snoring causes significant long-term injuries, including developing swallowing dysfunction and making patients more susceptible to developing obstructive sleep apnea (OSA). His research notes that snorers and sleep apnea patients have neuromuscular injuries in the upper respiratory tract both at the structural and molecular levels. Recurrent snoring doesn’t allow for these damaged tissues to heal.1

What’s more, preliminary research led by Adrian Curta, MD, a radiology resident at Munich University Hospital in Germany, has identified that women who snore are at much greater cardiac risk than men.2 “It is unfortunately still unclear why women are more susceptible to developing cardiac-related symptoms,” Curta says. He suspects many of the study subjects with cardiac alterations may also have undiagnosed OSA.

Beyond long-term significant health issues, snoring can have immediate consequences as well.

“Sleep is a critical element of everyone’s health, and poor sleep can negatively impact many aspects of a person’s wellbeing,” says Mark Aloia, PhD, global lead for behavior change with Philips Healthcare and associate professor of medicine at National Jewish Health in Denver, Colo. “Snoring is a prevalent sleep condition that not only affects the afflicted person but also impacts their most personal relationships. According to research, more than 40% of the global population snores, with side effects including excessive tiredness for both snorers and their bed partners. Because of the scope of influence a snorer can have on the quality of sleep for those around them, snoring—not related to sleep apnea—is an important challenge that should be addressed on its own.”

While CPAP is commonly referred to as the gold standard for treating sleep apnea, there is no corresponding therapy for snoring. But

To Compete With Startups, Old-School Mattress Makers Plug Into Data

Tempur Sealy announced its latest bid to win back your bedroom: a smart sleep “system” called the Tempur-Ergo Smart Base Collection with Sleeptracker technology. It uses an array of sensors to monitor heart rate and respiration, plus environmental conditions in the bedroom, like temperature, humidity, and air quality.

The real clincher, though, is the new “snore detection technology,” which leverages all that sensor data to detect the faintest whiff of a snore and gently reposition your head to make you stop.

“It automatically elevates the head of your bed, between 11 and 13 degrees,” says Tom Murray, Tempur Sealy’s senior vice president and marketing officer. “For many people, that inclination can help to alleviate the snoring. It will be the first product to market that does that automatically.”

from Sleep Review…

More Than 936 Million Have Obstructive Sleep Apnea Worldwide

More than 936 million people have obstructive sleep apnea—the disorder’s first prevalence update in more than a decade—according to The Lancet Respiratory Medicine.

The Lancet published a multinational analysis by ResMed and 12 sleep researchers. The results were first presented at the American Thoracic Society 2018 International Conference in San Diego.

This figure is nearly 10 times greater than the World Health Organization’s 2007 estimate of more than 100 million, renewing calls for physicians to step up their efforts to screen, diagnose, and prescribe treatment for those who unknowingly have the disorder.

“More than 85% of sleep apnea patients are undiagnosed, meaning hundreds of millions repeatedly suffocate instead of getting healthy, restful sleep each night,” says Carlos M. Nunez, MD, a study coauthor and ResMed’s chief medical officer, in a release. “This raises their risk of workplace and roadway accidents, and can contribute to other significant health problems, such as hypertension, cardiovascular disease, or even poor glucose control for diabetic patients. We know the risks, and now we know the size of the problem is nearly 10 times greater than previously thought. Addressing it starts with screening patients we know to be high-risk.”

Why Is Sleep Apnea Mostly Undiagnosed?

“Many will attribute the resulting tiredness to aging or stress,” says Nunez. “Others will mention the problem to their doctor, only to be misdiagnosed with insomnia, migraines, chronic fatigue, or other conditions. Misdiagnosis is especially common with women, since sleep apnea was long thought to be much more common in men.”

Today, women account for 40% of newly diagnosed sleep apnea patients.

Another reason may be undiagnosed can be blamed on cultural ideas of what constitutes good sleep.

“For instance, some believe snoring may simply be a normal feature of how some people sleep, when in fact it’s one of the most important signs for the risk of having sleep apnea,” Nunez says. “With a global prevalence that approaches 1 billion people, patients and physicians need to consider the risks and ask the questions that may ultimately help them sleep and live better. This is no longer a problem that

Demystifying Intraoral Scanning in Dental Sleep Medicine

A Diplomate shows dentists the ins and outs of accurate digital impressions for sleep appliances.

Intraoral dental scanners provide dentists with a tool that can digitally capture the images of teeth and surrounding soft tissue with astonishing accuracy. The clinician simply waves a rather expensive wand over the teeth and a rotatable image instantly appears on the screen. This new technology can represent an opportunity to replace old methods with one that is faster and more comfortable for the patient. But the unknowns of scanning can be intimidating, as is the case for many dentists whose training and experience have always focused on physical impressions and plaster models. Although the presence of scanners in dentistry is becoming increasingly more common, it is estimated that less than 25% of dental offices own a scanner, and those that do tend to be larger multi-dentist practices.1

How do a scanner handpiece and a computer produce a printable 3D image? As Yale University professor of biomedical engineering James Duncan, PhD, a pioneer in 3D image technology, explains, scanners “gather information about the shape and size of dental structure or arches as well as the position of implants by first projecting structured light (basically a light grid pattern) or a laser beam onto a tooth’s surface and then recording how the pattern or the beam is changed or distorted when it hits the surface using very high resolution cameras. Then software is used to reconstruct or form a full 3D model of the structure by fitting a polygonal mesh to a large set of points that cover the tooth or teeth being studied.”

In dentistry, increased accuracy means fewer remakes and reduced chair time for insertion adjustments. Recent tests on in-vitro models have shown scanners to have accuracies (trueness) in the range of 50 micrometers (ranging from 20 to about 100 micrometers).2,3 David Walton, CEO and founder of sleep apnea therapy company Respire Medical (acquired by Whole You), welcomes scans for oral appliances. “Due to the accuracy of digital scans, not

Toward a Better Understanding of Sleep Surgery

The international sleep medicine community gathered in New York City to discuss hypoglossal neurostimulation therapy, personalized treatment of sleep apnea, snoring and much more.

Picture an international gathering of expert sleep apnea surgeons, sleep medicine specialists, and dental sleep medicine practitioners and you have the 10th International Surgical Sleep Society meeting that took place in New York City from May 9-11, 2019. About 400 attendees from 36 countries met to discuss the pathophysiology of obstructive sleep apnea (OSA), updates on current treatments, and future directions for OSA treatment. About 100 speakers from around the world participated in presentations and lively discussions.

“The concept of the meeting was to provide highly concise, high level presentations on advanced OSA topics and to stimulate open, intellectual, collegial exchange in and out of the sessions,” says Ofer Jacobowitz, MD, PhD, co-director of sleep at ENT and Allergy Associates, NY, who chaired the meeting with Maria Suurna, MD, from Weill Cornell Medicine, NY. The format allowed for question and answer sessions to encourage interaction of attendees with international sleep surgery experts.

Immediately prior to the main meeting, a special research forum entitled “Maximizing success of implantable hypoglossal neurostimulation therapy” was held at Steelcase in New York City. The option of hypoglossal neurostimulation (HGNS) is an addition to the treatment array for CPAP-intolerant patients and fosters collaboration between sleep medicine and surgery specialists. International experts discussed a variety of HGNS topics such as: which measures of OSA disease burden should be used to define success, patient features that may predict apnea-hypopnea index (AHI) reduction, technical aspects of implantation and stimulation, and possible sequential or concurrent treatments to optimize success. Currently body mass index, AHI, and sleep endoscopy are used to select patients for HGNS, but meeting presenters said that more precise criteria are needed.

Experts said it appears that women may be more likely to have success with HGNS. In contrast, those whose OSA has a significant psychophysiological insomnia component may not tolerate stimulation well and thus perhaps should be screened out. Optimization of outcome was an important topic, including combination therapy of HGNS with upper

Company Closes Series 2 Funding Round for Continued Development of Daytime Neurostimulator for Snoring, Mild Sleep Apnea

Signifier Medical Technologies, which is developing the “Snoozeal” daytime neurostimulator for snoring and mild obstructive sleep apnea (OSA),  has closed an oversubscribed Series B funding, aiming to invest further in R&D and prepare the company for commercial stage. With this round, Signifier Medical Technologies has raised a total in excess of $13 million since its founding in 2015.

The new funds will enable Signifier Medical Technologies to:

  • accelerate the data generation in ongoing clinical trials with its Snoozeal with key opinion leaders in sleep conditions in  academic centers, including: University College London; University of California – San Diego and New York Presbyterian – Cornell University;
  • complete the FDA approval process, with de novo filing anticipated in 2019;
  • further invest in expanding its product range, including adding advanced analytics capabilities; and
  • expand the team to broaden its capability set, including commercial readiness in key geographies.

SnooZeal’s technology sends gentle electronic pulses to the back of the tongue to tone the muscles, which the manufacturer states reverses the over-relaxation of the tongue and stops snoring. It is used for for 20 during the day.

“Signifier Medical Technologies is aspiring to revolutionize the sleep market,” says Anshul Sama, BMedSci, BM, BS, FRCS, FRCS, co-founder and chief medical officer of Signifier Medical Technologies, in a release. “For the last few years, we have been developing a novel and ground-breaking device that will help solve the conditions of snoring and mild OSA, which affect over 110 million people in the US and 100 million people in Europe.

“This capital raised will allow us to invest further in R&D and increase our speed of innovation. We are leveraging our proven technology and expanding our pipeline to include additional cutting-edge products that will allow us to extend the indications we can address into the mainstream treatment of OSA. This will enable us to make a real impact on the lives of millions of people, in an area with significant unmet medical need.”

The Series B round was led by The Pritzker Organization, a family merchant bank that focuses on long-term growth capital. It includes participation from new

We Tried It: 3 Popular Anti-Snoring Devices

After years of sleeping next to a snoring partner, A Healthline reporter tries to put an end to noisy nights.

I can’t count how many times I’ve been jolted awake in our San Francisco home thinking “the big one” just hit California, only to realize the rumble that shook me out of my dream was simply my husband, John, snoring less than a foot away.

Suddenly, those ads for over-the-counter snoring gadgets began to look pretty promising.

So, after a particularly noisy night, we recently looked at some of the top options on Amazon and decided to give three different devices a try.

from Sleep Review…

Sleep Apnea: Why You Feel Tired After a Full Night of Sleep

CNET’s guide goes over the different types of sleep apnea, causes, risk factors, and symptoms to help people understand sleep apnea.

The most common symptom of sleep apnea is snoring, but snoring on its own isn’t always indicative of sleep apnea. Snoring followed by silent pauses, gasping or choking sounds is likely a sign of sleep apnea.

Because sleep apnea wakes you up frequently throughout the night (even if you don’t notice it), you can suffer from symptoms of sleep deprivation, such as daytime fatigue, difficulty concentrating, unintentional napping and irritability or mood swings.

from Sleep Review…