Transcend CPAP Aims for Travel Market

ScreenShot227 Transcend CPAP Aims for Travel MarketOfficials at Somnetics International plans to expand awareness of their product in 2012 while honing in on the cash/retail niche.

In a world where tiny iPods hold thousands of memory-intensive songs, should it be any surprise that a CPAP machine finally weighs less than a pound? Clarence Johnson, president and CEO of Somnetics International, observed the trends over the last decade, and decided to start a mini revolution of his own.

The result is the Transcend Sleep Apnea Therapy Portable CPAP System, a unit that company officials say is the smallest, lightest, and most portable CPAP on the market. “It also has the smallest, lightest, and most portable battery,” says Johnson, who relied on more than 25 years in the biotechnology industry prior to starting Somnetics 3 years ago. “These two things, in combination with the waterless humidification technology, will transform the way CPAP is delivered.”

Somnetics received FDA market clearance for the Transcend obstructive sleep apnea therapy device in July 2010. A little more than a year later, judges at the 2011 Medtrade show in Atlanta gave Transcend the Innovation Award for the product that best exemplifies high tech and state-of-the-art design.

Johnson knows that well-funded marketing departments at manufacturing juggernauts will try to overshadow the positive news, but he’s confident the message will spread. “To compete with the large companies head on would be folly,” says Johnson from his Minneapolis office. “Instead, we believe we have identified a route to market that is unique. Our product is unique, and we think our product strategy can succeed.”

Expanding Awareness
With increased utilization of direct-to-patient marketing, the young company intends to partner with DME and sleep physicians to reach out to the installed base of existing CPAP users. “We also need to market to DMEs and sleep physicians,” adds Johnson. “We want them to know that we intend to partner with them to improve their retail sales with a small and innovative CPAP.”

In addition to the unit’s compact size, judges at Medtrade appreciated the fixed pressure CPAP’s automatic altitude adjustment, good for up to 8,000 feet, with AHI and leak detection reported to compliance software. Tight pressure control at the mask means consistent performance that Johnson maintains is more than suitable for everyday use.

Sleep Doctors who may be unaware of the Transcend, will notice change in 2012. “We should be in sleep labs, but just have not gotten there yet,” adds Johnson. “We exhibit at the sleep meetings, and many sleep docs who attend the meetings have seen the device, and many will soon have an opportunity to try it on patients. One of our great marketing challenges for 2012 is to expand the knowledge of our product within the sleep physician community.”

Cash is King
Officials at Somnetics believe their product is ideal for self dispensing sleep labs looking for a viable cash retail device. Accepting that the Transcend won’t likely be considered as a first-line therapy device any time soon, Johnson believes his product’s niche is currently the growing travel market. “There is a big market for people who buy second CPAPs for travel,” he says. “We believe we can help create a bigger market there with our battery powered unit. For those interested in selling CPAPs for cash, we are a perfect partner. We will help market to your base, and give our customers all the marketing materials they need for free.

“We don’t want DMEs and sleep labs to add our device as a third- or fourth-entry primary device, because it will just sit on the shelf,” continues Johnson. “We think our first and best route to market is through patients who already have and understand CPAPs, and know what features they are looking for. Ultimately, patients will know about the device, and ask for it.”

For DMEs and self-dispensing sleep labs looking for cash sales, Transcend can attract customers looking for secondary travel devices. “Certainly Transcend is reimbursed like other CPAPs, so physicians can send patients to DMEs, and those DMEs can provide this as a primary device,” says Johnson. “And of course, when patients want to travel, they can do it. No other device is that convenient. Every other device is heavier, bulkier, bigger, and creates problems.”

Transcend can be carried and used on a flight, and as a medical device it does not count as a carry-on item. Sleep lab directors and DME providers should advise users to never check a sleep apnea therapy device with baggage because the chances for damage are high. “A doctor can provide a letter stating the user’s diagnosis and the need to carry and use the device on the plane, if necessary,” says Johnson. “Users should call the airline in advance to clarify procedures and in-flight policies.”

For the Medicare and insurance market, the Transcend is reimbursed under the same codes as any other CPAP. The device is not an auto-pap, but instead a fixed pressure CPAP. “We stop recommending at 16 cm of water for pressure,” says Johnson. “For anything above that, we think expiratory relief or Bi-PAP is required. The only thing we don’t have is expiratory relief. Other than that, Transcend is fully featured, and even has more features than some units.”

Waterless Humidification
One crucial feature of the modern CPAP is humidification, and Johnson reiterates that Transcend uses heat moisture exchange technology, which hospital-based respiratory therapists have long relied on for critical care ventilation patients. “We have a great deal of intellectual property developed around the concept of applying this technology to CPAP,” says Johnson, who holds a Master of Science degree in microbiology (biochemistry) from the University of Minnesota.

Somnetics is the first company to offer heat and moisture exchange humidification, a staple for patients on long term ventilation, but not used in CPAP until now. “An insert fits into the breathing circuit and captures exhaled moisture and warmth and returns that to the patient when they inhale with the next breath,” explains Johnson. “It is effective and satisfies humidification needs. When it becomes more widely understood, it will be an attractive option because it is small, easy, and portable. There is no hassle, no mess, and no water. It is a viable alternative to heated humidifiers.”

Somnetics sells its products through an established network of distributors and direct sales representatives serving markets across the U.S., and in key markets around the world. The unit is reimbursable under the standard CPAP HCPC code, and is accepted by most insurance companies.

As the Transcend launch continues, buyers can purchase with a standard 6-ft hose that will work with any mask or seal on the market. Two battery options are available, one with an overnight capacity of 7 to 10 hours at a pressure of 14 cm. “Another option is a multi-night battery that will last 14 to 16 hours minimum at 14 cm,” adds Johnson. “Both batteries work as uninterrupted power supplies for people living in hurricane zones or zones with frequent power outages. Ultimately, we listened to patients in putting this device together, and we feel we have incorporated what they want.”


For more information about the Transend, visit

At a Glance

  • Transcend’s universal AC power supply automatically converts the power current for international use.
  • Transcend and its accessories and parts are available at medical equipment dealers.
  • Transcend is competitively priced with other CPAP devices on the market.
  • The system comes with a 2-year manufacturer’s warranty.
  • The Transcend Sleep Apnea Therapy Starter System is compatible with any CPAP mask via the Universal Hose Adaptor and standard 6-foot hose.
  • The Transcend H6B and H9M Waterless Humidification Systems come with a proprietary interface that can be fitted with adaptors that are compatible with the most commonly used nasal seals.
  • Automatically compensates therapy pressure to altitudes of up to 8,000 feet.
  • Mobile power adaptor plugs into the DC power outlet in a car, truck, RV, boat, camper or mode of transportation with power. Mobile power adaptor can recharge the Transcend battery pack.
  • P4 Overnight™ battery system provides sufficient power to operate the device for 7 to 9 hours at a pressure setting of 14 cm H2O. The P8 Multi-night™ battery system provides power for 14 to 16 hours of use at the same setting. Both the P4 and P8 batteries are designed to accommodate more than 250 discharge/recharge cycles with standard use.
  • Transcend uses patented heat moisture exchange (HME) technology to provide humidification during therapy.
  • The hygienic heat moisture exchanger (HME) is disposable and has no electric heating elements. HME technology works naturally with the user’s breath to provide humidification.
  • Because it features waterless humidification, Transcend can be placed on the bed, on a pillow, in the bed stand drawer, or on the floor – wherever it’s most convenient.
  • Air bearing blower technology makes Transcend quiet and vibration-free.

Association Between Obstructive Sleep Apnea and Sudden Sensorineural Hearing Loss

Jau-Jiuan Sheu, MD, MPH; Chuan-Song Wu, MD, MPH; Herng-Ching Lin, PhD

Arch Otolaryngol Head Neck Surg. 2012;138(1):55-59. doi:10.1001/archoto.2011.227

Objective To examine the putative association between obstructive sleep apnea (OSA) and sudden sensorineural hearing loss (SSNHL) using a nationwide population-based data set. Obstructive sleep apnea has been associated with generalized inflammation and nervous-endocrine, cardiovascular, and other systemic biophysiologic phenomena. However, to our knowledge, no investigations have been conducted using large data sets to examine the association between OSA and auditory disorders.

Design Case-control study.

Participants We identified 3192 patients diagnosed with SSNHL from the Taiwan Longitudinal Health Insurance Database as the study group and randomly extracted the data of 15 960 subjects matched by sex, age and year of first SSNHL diagnosis as controls.

Main Outcome Measures Cases of OSA were identified by having been diagnosed as OSA prior to the index date of SSNHL diagnosis. Conditional logistic regression matched on age group and sex was used to assess the possible association between SSNHL and OSA among the sampled patients.

Results Of 19 152 patients, 1.2% had OSA diagnoses prior to the index date; OSA was diagnosed in 1.7% of the SSNHL group and 1.2% of the controls. After adjusting for sociodemographic characteristics and co-morbid medical disorders, we found that male patients with SSNHL were more likely to have prior OSA than controls (odds ratio, 1.48; 95% CI, 1.02-2.16) (P = .04). No such association was found among female patients.

Conclusions Male patients with SSNHL had a higher proportion of prior OSA than non-SSNHL-diagnosed controls; no such association was found among female patients. Further study will be needed to confirm our findings, explore the underlying pathomechanisms, and investigate the difference between sexes.

Randy Clare

Randy Clare

Randy Clare brings to Sleep Scholar more than 25 years of extensive knowledge and experience in the sleep field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. Mr. Clare's extensive sleep industry experience assists Sleep Scholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders.

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Stellar Results with Hybernite Heated Tubes

Hybernite system 42 300x235 Stellar Results with Hybernite Heated TubesOnce overlooked as a relatively minor part of the CPAP setup, heated tubes are joining humidifiers as viable ways to recuperate dissatisfied patients.

Are there patients who don’t like the comfort benefits of Hybernite® Rainout Control (ROC) System heated tubes? Johan Verbraecken, MD, concedes that they might be out there, but he has yet to come across any.

As a pulmonologist and medical coordinator at the Belgium-based Sleep Disorders Centre, Verbraecken is all too familiar with the complaints that come with CPAP therapy. Side effects such as rhinitis and a wet face in the morning can derail even the most patient of CPAP users.

Verbraecken, who also serves as e-learning director of the European Respiratory Society, saw this recently in a 5-year CPAP user who happened to work in the security department of a nuclear power plant. The man had successfully used CPAP for 5 years, but started suffering from rainout and/or excessive moisture. “We advised him to sleep with the windows closed, and eventually to warm up the room temperature,” says Verbraecken. “We also offered him a sleeve to protect the tube, but these measures were not effective. He refused to close the windows because he said he could not sleep. He started the Hybernite, and the last time I saw him he was happy with what he called a ‘perfect solution.’ The windows remained open and he was content.”

Meanwhile, physicians may opt to administer nasal corticosteroids to counter some side effects, and humidifiers are always on the docket. When humidifiers alone do not do the trick, Verbraecken does not hesitate to talk about Hybernite, an affordable option, which most people are more than willing to pay. “Every person who has tried the Hybernite heated tubes has liked it—every single one,” he muses.

Why not recommend it right off the bat? Ultimately, Verbraecken prefers to use an incremental approach. “Some patients are happy with the results of the heated humidifier alone,” explains Verbraecken. Despite stellar results with heated tubes, Verbraecken believes most physicians don’t really ponder the negative aspects of CPAP. As a result, knowledge of heated tubing is relatively low.

In some cases, misconceptions may still exist. “When the technology was in development, there were concerns that heated tubes could lead to bacterial contamination and overgrowth, but that is not a problem,” says Verbraecken. “It could be a problem if people use the tube for a long time and do not keep it properly cleaned, but that is also true with non-heated tubes. We would have seen more upper airway infections if concerns were justified, and we have not seen that at all.”

Beyond the physical side effects that can resemble the common cold, unwanted noise is often added to the annoyance list for many CPAP users. Surprisingly, heated tubing can help. “If you have a lot of rainout in the tube, you get a collection of water at the lowest point of the tube,” says Verbraecken. “If you add air, this can lead to bubbling noise which can be irritating. By adding the Hybernite, you can recuperate some patients who may have fallen out of compliance due to this seemingly small annoyance.”

Humble Beginnings
About 2 years ago, a company called Plastiflex Healthcare, a division of Plastiflex Group NV, decided to use its considerable experience manufacturing industrial flexible hoses and apply it to CPAP. Plastiflex contacted Verbraecken’s Centre in an effort to reach the European market.

Plastiflex developed the Hybernite® Rainout Control (ROC) System, which includes the proprietary Hybernite® Heated Breathing Tube (HBT) and Hybernite® Power Supply Unit (PSU). The HBT connects to the PSU via a plug-and-play connector, with copper wires embedded in the tubing wall.

The wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. Verbraecken notes that the wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube—and the resulting accumulation of moisture. The combination of the heated tube and the humidifier works to control condensation.

Universal Use
Verbraecken says the Hybernite’s appeal stems from its ability to be used with each kind of humidifier. Other heated tubes on the market can only be used on one machine. “This tube is universal,” says Verbraecken. “That is a major advantage.”

Some manufacturers choose to make tubes that are only compatible with their own machines—a mistake in Verbraecken’s eyes. “Another major heated tube has no independent current, so it gets power from the CPAP machine,” he says. “You can’t combine it with another machine. That is a disadvantage.”

Johan Verbraecken, MD, is a pulmonologist and medical coordinator at the Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp. He serves as vice president of the Belgian Association for Sleep Research and Sleep Medicine and e-learning director of the European Respiratory Society.

Sleep Hygiene Linked to Post-op Behavior Problems in Peds

by Michael Vlessides

Chicago—Children who experience sleep-disordered breathing are significantly more likely to exhibit maladaptive behaviors following surgery than those without the respiratory problem, a new study has found.

The investigators, from the University of Michigan, in Ann Arbor, said they were intrigued by the fact that postoperative behavioral problems—like fussiness, disobedience and introversion—also seem to be mitigated by daytime sleepiness.

“All of us have taken care of obstructive sleep apnea patients at one time or another,” said Robert E. Christensen, MD, clinical lecturer in anesthesiology at the institution. “Sleep-disordered breathing represents the full spectrum of disorders, not just those patients who qualify for the full diagnosis of obstructive sleep apnea. We were interested in those patients, specifically in their postoperative behavior and the impact of anesthesia there.”

Although children with sleep-disordered breathing are known to be at increased risk for airway complications after surgery, information regarding postoperative behaviors in this population of patients is scarce.

Dr. Christensen and his colleagues enrolled 337 children, aged 2 to 14 years, scheduled for elective surgery in their study. Before the procedures, parents of the subjects completed the Sleep-Related Breathing Disorders subscale (SRBD) of the Pediatric Sleep Questionnaire. Children with scores of 0.33 or higher on the SRBD were considered to have sleeping trouble, including sleep-disordered breathing, snoring and daytime sleepiness.

One week after surgery, the Michigan researchers readministered the SRBD scale to parents, who also completed a questionnaire about their child’s behavior after discharge. A behavior was considered maladaptive if parents rated it as “more/much more” than normal.

The investigators, who reported their results at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 049), found that 26.7% of children had sleep-disordered breathing. Those who did were significantly more likely to exhibit maladaptive behaviors following surgery than children with healthier sleep hygiene.

Several other factors were significantly associated with maladaptive behaviors, including being overweight or obese, having had an adenotonsillectomy, preoperative and postoperative snoring and daytime sleepiness before and after surgery (P<0.01). Adenotonsillectomy (odds ratio [OR] 9.89; P<0.01) and postoperative daytime sleepiness (OR 2.8; P<0.01) also were independent risk factors for maladaptive behaviors. “Where it got really fun was when we started breaking down the elements of sleep-disordered breathing subscales,” Dr. Christensen noted. “And when we looked at the entire group—those with and without sleep-disordered breathing—those with daytime sleepiness had more behavioral problems.” This finding suggests that sleep hygiene, and the underlying sleepiness, might be leading to the increased behavioral problems, not simply the sleep-disordered breathing itself, Dr. Christensen said. If the link holds up in future studies, clinicians could alert parents to the importance of good sleep hygiene before and after surgery. Mehernoor Watcha, MD, associate professor of pediatric anesthesiology at Baylor College of Medicine in Houston, congratulated the researchers for following their patients beyond the recovery room. “Most of us think ‘Hey, I got them out of the PACU [postanesthesia care unit], my job’s done,’” Dr. Watcha said. But the new data show that “patients who have what is considered a normal recovery still continue to have behavioral problems for some time at home, and this is a problem as far as the parent is concerned. “I wonder if any particular type of anesthetic intervention is going to change this,” Dr. Watcha added. “Either way, I think it’s very important to continue this type of work.” Clinical Anesthesiology ISSUE: FEBRUARY 2012 | VOLUME: 38:2

Randy Clare

Randy Clare

Randy Clare brings to Sleep Scholar more than 25 years of extensive knowledge and experience in the sleep field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. Mr. Clare's extensive sleep industry experience assists Sleep Scholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders.

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Effect of mandibular position on three-dimensional shape of the oropharynx in seated posture


Summary  Dysphagia rehabilitation in the elderly includes direct therapy to alter the three-dimensional shape of the oropharynx so that food boluses can pass safely through the poorly functioning pharynx. Alteration of the mandibular position is thought to affect oropharyngeal shape, but this relationship remains poorly understood. We therefore studied the relationship between mandibular position and three-dimensional shape of the oropharynx in the seated posture normal for feeding. Ten healthy, dentate subjects participated (average age, 28·1 years). Experimental mandibular positions were the intercuspal position, bite-raised position and mandible-advanced position. The oropharynx was scanned in a 90° seated posture using dental cone-beam computed tomography, and the effects of changes in mandibular position were analysed after obtaining oropharyngeal volume, height, sectional area, average sectional area of oropharynx and the position of the epiglottis. Oropharyngeal volume and average sectional area increased significantly in the mandible-advanced position compared with other mandibular positions. Notably, the volume and average sectional area of the inferior part of the oropharynx increased significantly. Oropharyngeal height and sectional area at the base of the epiglottis showed no significant difference in bite-raised position and mandible-advanced position compared with intercuspal position. The position of the epiglottis moved significantly forward in the mandible-advanced position. The results of this study show that in a seated posture, volume of the oropharynx increases as a result of changes in the mandible-advanced position. The increase in oropharyngeal volume demands greater muscular constriction to generate swallowing pressure and could lead to a decrease in reserve capacity of swallowing.

Article first published online: 15 OCT 2011

DOI: 10.1111/j.1365-2842.2011.02263.x

Michael L. Gelb DDS

Michael L. Gelb DDS

Dr. Michael Gelb, with world class offices in both NYC and White Plains, New York is an innovator in sleep apnea, painful TMJ disorders, and other head and neck pain disorders. Dr. Gelb has studied breathing related sleep disorders (BRSD), specializing in how they relate to fatigue, focus, pain, and the effects all of these can have on a person’s life. The Gelb Center is known as “The Sleep Apnea / Sleep Disorders Specialist in NYC“, “The TMJ Specialist” and “The New York Headache Center” because The Gelb Center is the premier destination for patients suffering with TMJ, headaches, or sleep disorders. Dr. Michael Gelb is the Co-inventor the critically acclaimed Airway Centric ™ medical device as well as the NORAD, or Nocturnal Oral Airway Dilator appliance that reduces snoring by positioning the patient’s tongue and jaw so that airways stay open. Dr. Gelb has also updated the Gelb or MORA™ appliance, named after his father, a pioneer in the industry, and has multiple patents pending for sleep disorder devices and pain management. Dr. Michael Gelb is a highly rated author and speaker on TMJ, sleep apnea, sleep disorders, and chronic headache treatments. With over 30 years of experience, the renowned specialist has written and co-authored numerous journal articles and book chapters to share his knowledge and best practices with other doctors, specialists, and dentists. He has presented at numerous international meetings. With significant involvement in TMJ research and chronic headache teaching, The Gelb Center is committed to early adoption of the latest research findings, medical technology, diagnostic techniques & treatments into clinical practice in order to give the highest quality care to our patients.

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Sleep-disordered breathing, Hypertension and Obesity in Retired National Football League Players

Felipe N. Albuquerque, MD,* Fatima H. Sert Kuniyoshi, PhD,* Andrew D. Calvin, MD, MPH,* Justo Sierra-Johnson, MD, PhD,* Abel Romero-Corral, MD, MSc,*¥ Francisco Lopez-Jimenez, MD, MSc,* Charles F George, MD, FRCPC,& David M. Rapoport, MD,∞ Robert A. Vogel, MD,€ Bijoy Khandheria, MD,§ Martin E. Goldman, MD,¶ Arthur Roberts, MD,‡ and Virend K. Somers, MD, PhD

*Mayo Clinic College of Medicine, Mayo Clinic, Rochester, Minnesota
¥Albert Einstein Medical Center, Department of Internal Medicine, Philadelphia, PA
&University of Western Ontario, London, Canada
∞New York University School of Medicine, New York, New York
€University of Maryland School of Medicine, Baltimore, Maryland
§Mayo Clinic College of Medicine, Mayo Clinic, Scottsdale, Arizona
¶Mount Sinai Medical Center, New York, New York
‡Living Heart Foundation, Little Silver, New Jersey
Address for correspondence: Virend K. Somers, MD, PhD Professor of Medicine Division of Cardiovascular Disease Mayo Clinic College of Medicine 200 First Street SW Rochester, MN 55905 Phone: 507-255-1144

In 1994, the Centers for Disease Control and Prevention conducted a study evaluating retired National Football League (NFL) players. Linemen were three times more likely than other position players to die of heart disease, and had a 52% higher risk of cardiovascular death than the general population. It was speculated that a higher body mass index (BMI) among linemen was responsible for this increased cardiovascular mortality; however most of the established cardiovascular risk factors were not assessed in this study (1). Sleep-disordered breathing (SDB) and hypertension have been linked to several cardiovascular diseases (2) and evidence suggests that SDB may be highly prevalent in active NFL players (3).

The Living Heart Foundation, a nonprofit organization, conducted multi-city health screenings of retired NFL players in conjunction with Mayo Clinic and the NFL Players Association. Results were compared to the general population using data from the National Health and Nutrition Examination Survey (NHANES) 1999-2006 restricted to a sample of 1,539 males who were in the same age and BMI range as the former NFL players. A fasting blood sample was obtained during the screening visit. Obesity was defined as a BMI of ≥30 kg/m2. Blood pressure (BP) was measured 3 times by an automated arm cuff blood pressure recorder and an average of the readings was calculated. Hypertension was defined as a mean systolic BP ≥140 mmHg or a diastolic BP ≥90 mmHg per JNC VII guidelines.

Retired NFL Players were consecutively assigned to undergo a self-applied unattended limited-channel portable overnight sleep study (ARES, Advanced Brain Monitoring Inc., Carlsbad, CA or Embletta, Embla, Broomfield, CO) to assess SDB. We used an apnea-hypopnea index (AHI) of ≥10 events/hour to diagnose SDB. Retired NFL players were divided into linemen (offensive and defensive linemen) and nonlinemen (every other position). Group means were tested for differences by two-sided t-test or Wilcoxon rank sum test depending on data distribution. Differences in proportions were tested using χ2 and Fisher’s exact test when appropriate. The covariates of interest as predictors of SDB and hypertension were investigated using simple logistic regression and then multiple logistic regression analysis after adjusting for age and BMI.

A total of 257 retired NFL players underwent evaluation. SDB was present in 52.3% of the former NFL players. The prevalence of hypertension and obesity were higher in the retired NFL players, however, total cholesterol, triglycerides, HDL, and fasting glucose levels were lower compared to NHANES (Table 1). When stratified by position, linemen were more likely to have SDB (61.3 vs 46.6%, p =0.02) and obesity (83.5 vs 52.5%, p<0.001) compared to nonlinemen. Linemen tended to have a higher prevalence of hypertension (44.1 vs 34.0%, p=0.1), and had higher fasting blood glucose (107±2.9 vs. 98±2.3 mg/dL, p<0.0001) and triglycerides (150±12.7 vs. 112±9.8 mg/dl, p<0.001), but lower total cholesterol (183±4.1 vs. 193±3.1 mg/dl, p=0.02), HDL (42±1.3 vs. 45±1.0 mg/dl, p<0.001), and LDL levels (114±3.7 vs. 125±2.8 mg/dl, p=0.017) compared to non linemen. Covariates of age (OR per year =1.06, 95% CI= 1.03-1.08), BMI (OR=1.07 per kg/m2, 95% CI=1.01-1.12), and position (OR for linemen=1.81, 95% CI=1.08-3.07) were significant predictors of SDB. However, after adjusting for age and BMI, position was not a predictor of SDB (OR for linemen=0.70, 95% CI=0.37–1.29). Predictors of hypertension in retired NFL players were age (OR=1.04 per year, 95% CI=1.02-1.07), BMI (OR=1.10 per kg/m2, 95% CI=1.04-1.16), and SDB (OR=1.93, 95% CI=1.15-3.25). However, after adjusting for age and BMI, neither position (OR for linemen=0.98, 95% CI=0.53-1.86) nor SDB (OR=0.94, 95% CI=0.58-1.92) were significant predictors of hypertension. Our study demonstrates an increased prevalence of SDB, hypertension, and obesity in retired NFL players, particularly in linemen. Retired NFL players were less likely to have diabetes and had lower fasting glucose levels as previously shown in active players (4). This finding may be explained by the current or past exercise history in the former elite athletes, although a lower mean HDL cholesterol level may argue against this hypothesis. Results from multivariate analysis suggest that the higher prevalence of SDB in retired NFL players may be explained by the higher BMI. If true, this may serve as a warning to both retired elite athletes and physicians alike about the dangers of adiposity in later life, regardless of prior physical fitness. Even though study subjects were consecutively screened, volunteer bias could have resulted in a higher prevalence of SDB and hypertension. Another possible limitation of our study may be the use of a portable monitoring device to diagnose SDB. However, both devices used in our study have been validated and shown to be reasonably accurate compared to nocturnal polysomnography. We recognize that the accuracy of BMI in diagnosing obesity is limited, and can potentially overestimate its prevalence in certain populations as it cannot differentiate lean and fat mass. Finally, lack of SDB data in the NHANES sample limits our ability to fully compare our two study populations and our relatively small sample size limits more complex analyses. In summary, our data show that obesity is common in retired NFL players and is associated with hypertension and SDB. The negative health consequences of obesity in retired professional athletes may serve as a caution to not overlook this important health indicator, to take preventative measures, even among former elite athletes.

Randy Clare

Randy Clare

Randy Clare brings to Sleep Scholar more than 25 years of extensive knowledge and experience in the sleep field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. Mr. Clare's extensive sleep industry experience assists Sleep Scholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders.

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Heavy NFL players twice as likely to die before 50

By Thomas Hargrove
Scripps Howard News Service

The amazing athletes of the National Football League — bigger and stronger than ever before — are dying young at a rate experts find alarming, and many of the players are succumbing to ailments typically related to weight.

The heaviest athletes are more than twice as likely to die before their 50th birthday than their teammates, according to a Scripps Howard News Service study of 3,850 professional-football players who have died in the last century.

“ Do you see any oversized animals anywhere in the world living a long life? We’re pretty much on our own here. ”
— Tony Siragusa

Most of the 130 players born since 1955 who have died were among the heaviest athletes in sports history, according to the study. One-fifth died of heart diseases, and 77 were so overweight that doctors would have classified them as obese, the study found.

The bone-crushing competitiveness of professional football is spawning hundreds of these behemoths — many of whom top the scales at 300 pounds or more — and the pressure to super-size now extends to younger players in college and even high school.

As America anticipates Sunday’s Super Bowl — the annual orgy of admiration for the NFL and its athletes — physicians are increasingly questioning whether, by bulking up for their shot at fame and fortune, players are sacrificing their health later in life.

“Clearly, these big, fat guys are having coronaries,” said Charles Yesalis, a Penn State professor of health policy and sport science.

The trend lines are even more disturbing.

Twenty years ago, it was rare for a player to weigh 300 pounds. But more than 500 players were listed at that weight or more on NFL training-camp rosters this summer — including San Francisco 49ers guard Thomas Herrion, who collapsed and died after an exhibition game in August.

The relatively recent explosion in the number of 300-pound linemen “presents a frightening picture in terms of what we might expect 20 years from now,” said Dr. Sherry Baron, who studied the issue in 1994 for the National Institute for Occupational Safety and Health.

Jed Jacobsohn/Getty Images
The 49ers paid tribute to Thomas Herrion on during an exhibition game six days after he died.
Baron’s study, conducted at the request of the NFL Players Association, found that while players generally weren’t dying sooner than average, offensive and defensive linemen had a 52 percent greater risk of dying from heart disease than the general population.

The Scripps Howard study suggests that the risk for those heaviest players is increasing, although exact comparisons to the general population were impossible to make because so many factors — heredity, sedentary lifestyles, eating habits, as well as size — contribute to heart disease.

“We know that the body mass index levels have shifted since our 1994 study,” Baron said. “More [football players] now would be considered obese.”

Scripps Howard was able to compare mortality rates for professional-football players with the 2,403 Major League Baseball players who have died in the last century. The comparison found that football players are more than twice as likely to die before age 50. Asked to speculate on the cause for this difference, experts noted that football players generally are heavier than baseball players.

The threat isn’t lost on retired players, who acknowledge that they are spooked by the potential problems they now face.

“Do you see any oversized animals anywhere in the world living a long life?” asked Tony “Goose” Siragusa, a 340-pound defensive tackle for 12 seasons with the Indianapolis Colts and Baltimore Ravens. “We’re pretty much on our own here.”

The Scripps Howard study tracked the deaths of 3,850 pro-football players born since 1905. Medical examiners and coroners were contacted to determine the causes of death for the 130 players who died before age 50. The study found:

The Complete Study
Scripps Howard News Service studied 3,850 professional-football players who have died in the last century. What they found, and some issues it raised, are chronicles here:

• Study: NFL players dying young at alarming rate
• Compared to baseball, football players die younger
• Bigger isn’t better as far as health is concerned
• Evidence is clear: Preps are getting bigger, too
• Twenty-eight percent of all pro-football players born in the last century who qualified as obese died before their 50th birthday, compared with 13 percent who were less overweight.

• One of every 69 players born since 1955 is now dead.

• Twenty-two percent of those players died of heart diseases; 19 percent died from homicides or suicides.

• Seventy-seven percent of those who died of heart diseases qualified as obese, even during their playing days, and they were 2½ times more likely to die of coronaries than their trimmer teammates.

• Only 10 percent of deceased players born from 1905 through 1914 were obese while active. Today, 56 percent of all players on NFL rosters are categorized as obese.

• The average weight in the NFL has grown by 10 percent since 1985 to a current average of 248 pounds. The heaviest position, offensive tackle, went from 281 pounds two decades ago to 318 pounds.

The NFL has expressed concern over whether players are obese and risking health problems.

Forgotten in the frenzy surrounding Super Bowl XL is the tragic way the season started. The 6-foot-3, 315-pound Herrion collapsed in the 49ers’ locker room after the team’s Aug. 20 exhibition in Denver. An autopsy showed that his heart was scarred and oversized and that heart disease had blocked his right coronary artery. He was only 23.

At a memorial service for Herrion, NFL Commissioner Paul Tagliabue pointed out that he already had asked medical experts to study the cardiovascular health of players. That study is incomplete.

“We need to understand in a serious way what the risks are, to the extent that there are risk factors,” Tagliabue told reporters. “We’ve got to address them. We are working on it.”

But in a statement, NFL spokesman Greg Aiello dismissed the Scripps Howard study, saying: “The issue of obesity in our society transcends sports and must be dealt with in a comprehensive, responsible way. This media survey contributes nothing.”

Tagliabue wouldn’t comment for this article.

The NFL also criticized a 2003 study by University of North Carolina endocrinologist Joyce Harp. Published in the Journal of the American Medical Association, the study found that 56 percent of NFL players were obese according to their body-mass indexes — the government standard based on height and weight.

The Scripps Howard study also used the body-mass index to determine whether a player was obese. The NFL says it believes that standard is misleading because it doesn’t account for the player’s muscles. But many experts disagree and say that body-mass index is a valid indication that a player may face greater health risks.

“When you get that big — regardless of whether your body is muscle or fat — your heart is stressed,” Penn State’s Yesalis said.

“Is it good for guys to be that big? Of course not,” he said. “I fully support a weight limit of 275 pounds. It would reduce injuries and have a positive effect on the short- and long-term health of these men.”

The NFL Players Association declined to comment for this article. But Kevin Guskiewicz, director of the Sports Medicine Research Laboratory at the University of North Carolina, is conducting research for the association on the issue. He said he is alarmed at the information he sees.

“We are finding a number of health issues among these players,” Guskiewicz said. “They clearly have higher prevalence of cardiovascular disease and hypertension, especially in the offensive and defensive linemen. And it clearly is higher than in the general population.”

Defensive lineman William “The Refrigerator” Perry almost single-handedly brought 300-pounders into vogue when he became a pop sensation for the Chicago Bears. As a goal-line running back, he bulled his way to a touchdown in Super Bowl XX in 1986. Perry, who topped out at 370 pounds during his career, said he has actually gained some weight in retirement but tries not to dwell on the risks.

“I’ve been big all my life,” Perry said. “Mental attitude is as important as your physical condition after the NFL. I try to keep a happy balance.”

Weighty Issue
In November 2004,’s Page 2 looked at the size of NFL players. Take a look back at what we found:

• Caple: The NFL is living large
• ’04 NFL weight rankings
• Large and small of it
• ’79 Steelers vs. ’04 Steelers
Several retired players said they believe that losing weight is an issue of life or death.

“We’ve all got to remember to shed that armor when our NFL career is over,” said Jim Lachey, who is 25 pounds lighter since the days he weighed 294 while an offensive tackle for the San Diego Chargers, Oakland Raiders and Washington Redskins from 1985-95. “A lot of guys are doing it. But, I know, there are others with injuries that prevent them from running and doing the things they must do to shed the weight.”

Tony Mandarich — nicknamed “The Incredible Bulk” while playing guard at 325 pounds for the Green Bay Packers — said he gained even more weight after retiring and soon was put on high-blood-pressure medicine.

“My doctor asked me, ‘How many 320-pound men who are 80 years old do you see walking around?’ That’s when the lightbulb came on over my head,” Mandarich said.

He changed his diet, began hiking and mountain-biking regularly, and shed 60 pounds. “That doesn’t mean I won’t die of a heart attack at 39, but I’ve given myself the best chance,” said Mandarich, who is 39 now.

The wakeup for many retired players came with the 2004 death of two-time NFL Defensive Player of the Year Reggie White, known for his passionate religious faith and pass-rushing skills. He died at age 43 of cardiac arrhythmia compounded by breathing disorders.

“When I heard that Reggie had died, the first thing that came into my head was that I hoped he’d let himself go and was out of shape,” Mandarich said. “Because if he was in shape, it’s not a good thing for any of us.”

Actually, White had dropped about 25 pounds from his playing weight of 325, members of his family said. But he also suffered from sarcoidosis, or inflammation in his lungs, which led to thunderous snoring and a profound sleep apnea.

“These guys live such an extreme lifestyle with their weight that they are going to be prone to hypertension, diabetes and coronary artery disease. There is no question about it,” said Dr. Barry Maron, director of the Hypertrophic Cardiomyopathy Center at the Minneapolis Heart Institute Foundation.

Several medical examiners contacted by Scripps Howard remarked on the size of retired players who died of heart-related causes.

“He was a rather big boy at 6-foot-2 and 498 pounds,” said Steve Gelman of the San Francisco Medical Examiner’s office when asked why Joe Drake, a retired guard for the San Francisco 49ers and the Philadelphia Eagles, died in 1994 at 31.

“Essentially, he had clogged arteries and a heart attack. Mr. Drake was going out to lunch with some friends when he complained of sweating and nausea just before he collapsed on the street next to his car,” Gelman said.

Willis Leggett of Muskogee, Okla., said he does not blame football for the death of former Eagles offensive guard and tackle Scott Leggett. Doctors told Leggett that his son died of congestive heart failure at age 35.

“God put Scott on this earth and God took him off,” Leggett said. “If he hadn’t played football, he probably would have died sooner. Football was his goal and that’s what he wanted to do. No one could change his mind.”

(The Scripps Howard study created a computer database of the deaths of 3,850 former professional-football players using records assembled by professional-football statistician David Neft, who was assisted by Bob Carroll and Rich Bozzone.)

Randy Clare

Randy Clare

Randy Clare brings to Sleep Scholar more than 25 years of extensive knowledge and experience in the sleep field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. Mr. Clare's extensive sleep industry experience assists Sleep Scholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders.

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The Battle for Oral Appliance Legitimacy

If you’re living in a fox hole, CPAP is highly inconvenient. Army physicians took this simple truth and turned it into a study that has buoyed the case for adjustable oral appliances.

CPAP compliance can be challenging under ideal conditions. Add the dust, sand, and lack of electricity under combat conditions, and therapy adherence can be virtually impossible.

Major Aaron B. Holley, MD, FACP, ran an ICU unit in Afghanistan for 6 months where he treated combat-related injuries. He saw the harsh Arab landscape firsthand, a place where proper sleep is not a priority. Even in cases of clearly identified sleep apnea, most troops could not afford to give up pack space for CPAP devices and batteries.

Back home at Walter Reed National Military Medical Center (WRNMC), Bethesda, Md, Holley and Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, continued their work to improve sleep for veterans. They believed that if oral appliances (OAs) were as effective as they were convenient, they could ultimately contribute to a stronger fighting force.

Lettieri, Holley, and additional colleagues attempted to find the answer to this question, ultimately publishing research in the December 2011 issue of CHEST. The study, titled Efficacy of an Adjustable Oral Appliance and Comparison With Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea Syndrome, confirmed excellent results among mild to moderate sleep apnea sufferers.

Accidents and Explosions
Not surprisingly, the quality of sleep among soldiers can be a shambles during combat deployment. Explosions and less-than-ideal sleeping arrangements are unavoidable, but combined with sleep apnea can be even worse. “We know that most injuries are not battle related,” says Lettieri, a co-author of the study. “We have accidents, and if soldiers are sleep deprived, they are going to lack focus and be more prone to accidents.”

It’s a problem on U.S. roadways, but the stakes are even higher when lethal machinery is mixed in. “If you are driving a 40-ton tank around, you can’t afford to make bad decisions,” adds Lettieri, program director, Sleep Medicine Fellowship, WRNMC. “Research shows that chronic low-level sleep deprivation impairs reasoning, decision-making, and slows reaction time. You don’t want that in a combat-deployed troop.”

Beyond the obvious benefits of reduced accidents and convenient placement in a ruck sack, they found that even post traumatic stress disorder (PTSD) may be affected by poor sleep. “We have all these guys coming back with PTSD, and we broke it down into guys who were injured, and those who were not,” explains Lettieri. “Among guys who did not sustain a combat injury, almost universally they had some underlying sleep disorder.”

“When I was over there, we were sleeping next to an air field,” adds Holley. “It’s the nature of deployment that you don’t get a fixed and regular sleep schedule. Even if you take out PTSD and the anxiety of being subjected to mortars and rockets, you still have a situation where people are getting disturbed and fragmented sleep at best.”

Between 2004 and 2006, the Walter Reed sleep clinic gave out oral appliances and CPAP to service men and women on active duty. “When they went to a place without electricity, it would cause problems and sometimes even prevent some people from being able to go overseas,” explains Holley. “The dusty dirty environment made CPAP too difficult to keep clean. Filters in the machines were frequently going down and having problems.”

Large Pool Yields Better Findings
Armed with findings from one of the largest patient populations to date, Army researchers found that adjustable OAs are nearly as effective as CPAP treatment for patients with mild to moderate OSA, and are more effective than fixed oral appliances—particularly in patients with moderate to severe OSA.

“Historically, CPAP has been the primary treatment for OSA, but only half of patients tolerate this therapy,” says Lettieri, an Army medical director, and the chief of Sleep Medicine in the Pulmonary, Critical Care and Sleep Medicine Department at WRNMMC. “This new data offers a fresh look at adjustable oral appliances as an initial treatment for OSA in both the military and civilian sectors.”

The military is interested in the potential of adjustable OAs, also called mandibular advancement devices, as alternatives to CPAP systems since some active duty service members deploy to remote environments where electricity is not always available. In these cases, reliance on CPAP may result in duty restrictions or separation from service. “Adjustable OAs would eliminate duty assignment limitations associated with CPAP, allowing soldiers to travel to remote areas as needed,” adds Lettieri.

The study in CHEST evaluated and compared results of overnight sleep studies in which patients used adjustable OAs or CPAP devices. Researchers found that a significantly higher percentage of patients using an adjustable OA experienced successful reduction of their AHI score to below five apneic events per hour, compared to past reports (62.3% versus 54%).

In most research trials of oral appliances, patients receive oral appliances after they have already failed with CPAP.  It amounts to a selection bias because patients have already failed, and researchers often never really know why they failed. “We thought our data set was unique because a fair proportion of our patients did not fail CPAP since they were given both at the same time,” explains Holley. “The problem with doing this in the real world is you run into cost limitations. It is not cheap to do either of these therapies individually, never mind giving both to everyone up front. This is true in the military or civilian world.”

Changing Perceptions
Holley contends that physician “CPAP followers” are fairly devoted, tending to favor the humidification features of the modality. “Some docs are comfortable with what they are comfortable with, regardless of the evidence, even when it is compelling,” laments Holley. “It takes time to change people’s minds. How much will change with this study is hard to say. I would hope we have at least shifted the thought process and debate so that pulmonologists like me are more likely to not automatically go to CPAP for mild to moderate. It really does work just about as well as CPAP for people who have mild to moderate disease.”

Lettieri and Holley believe the study will (and should) contribute to a shift toward considering OAs earlier in the patient experience. More comparisons with CPAP are necessary, but Holley admits it can be difficult to level the playing field. “CPAP is electronic with a smart card that records compliance,” he says. “We know exactly how well it’s working. The struggle with studying oral appliances is that you must rely on self reporting from patients as to how much they use it. We can prove that oral appliances work, but the next thing to prove is if patients actually wear them more than CPAP. We suspect they do, but we have yet to prove it.”

Building the case is something that Lettieri is content to do. As a 40-year-old physician in a relatively young field, he has seen awareness grow exponentially, and he has helped the military change its perceptions. At Walter Reed, the size of the sleep lab has doubled in recent years and the staff has tripled. Consults have gone from 70 per month to often 70 in a day.

In a culture where sleep deprivation is part of the culture, Lettieri admits that raising awareness has not always been easy. “When I enlisted, the recruiting slogan was ‘We do more by 9:00 a.m. than most people do all day,’” he muses. “We get up early and operate at night. There is a sleep-when-you-can mentality. Americans as a whole keep shortening their average sleep time at night. Since the 1970s, we have about 1.3 hours less per night. The military is even worse.”

SIDEBAR: Military Intelligence
As program director of the Sleep Medicine Fellowship at Walter Reed National Medical Center, Bethesda, Md, Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, has seen the evolution of sleep medicine. In a culture where sleep deprivation is often considered a badge of honor, the 40-year-old Lettieri has succeeded by educating top brass and soldiers alike with a powerful message: Well-rested soldiers are more effective in the field of battle.

Nowadays, the sleep lab at Walter Reed is a full-fledged sleep disorders center that is recognized as a center of excellence. In addition to pulmonologists, neurologists, pediatricians, and even psychiatrists are applying for fellowship training. Sleep Diagnosis & Therapy sat down with Lettieri to talk about the explosion in sleep awareness and the implications for the military.

How tough is it to get proper rest in the military?
Lettieri: If you are talking about deployment, your sleep quality gets worse because you go from the relatively quiet environment to sleeping among a bunch of other people. There is more noise, radios, helicopters, explosions, and the constant stress.

Is sleep apnea more or less common in the military population?
Lettieri: Sleep apnea is common in general, and it’s common in the military. Even though we tend to be younger and more physically fit, we still have a lot of sleep apnea.

Why is that?
Lettieri: Some of it is anatomic, but a lot of it has to do with chronic low level sleep deprivation. You lose your ability to maintain tone of your upper airways. Back when I was a fellow, I did a research study called, “Obstructive Sleep Apnea Syndrome: Are We Missing an At Risk Population.” Across America, most people thought about sleep apnea in the 55 year-old overweight guy snoring in your waiting room. But really you see it in younger, thinner people. And if you don’t think about it, you’re going to miss the diagnosis.

Are physicians outside of the sleep realm starting to think about sleep apnea outside of the stereotypical patient categories?
Lettieri: With some of my prior research, and in a lot of the lectures I do now, I am trying to get people to think about it in the less typical person, such as the younger girl with chronic headaches and depression. Or the young guy who has unexplained fatigue and ADHD. I’ve always thought we had a lot of it in the military because of this chronic low level sleep deprivation.

Are there examples among fit combat soldiers?
Lettieri: We have had young, active duty guys who get diagnosed with sleep apnea. If it is toward the earlier part of the war, what do you do with them? You cannot bring CPAP in the theater with you. If you’re living in a fox hole, where are you going to plug it in?

Are CPAPs possible at the larger bases?
Lettieri: Even with the more mature theaters we have now, where everybody has laptops plugged in and lamps, you still can’t plug in a CPAP. The Central Command that runs the war said you can’t bring it.

So what do you do now? You’ve got a young guy, and if you tell him he has sleep apnea, he may be out of a job. The alternative is oral appliances.

When did oral appliances emerge as a viable alternative?
Lettieri: A couple of years ago, when we started this, oral appliances were largely considered an alternative to CPAP. You could consider oral appliances if they had a really mild disease, or really hated CPAP.

What do you with young guys who have severe disease?
Lettieri: You can’t say, ‘Well you’re out of the army.’ So we pushed the envelope way beyond what was accepted, because we didn’t want anyone to be forced out of the Military because of sleep apnea” At one point, we had more experience with oral appliances than most of the country combined. We had to get this message out, so we published two papers almost back to back.

Why did you focus so much on the oral appliances?
Lettieri: We did it largely to conserve the military fighting strength. On one hand, we want to find alternatives to CPAP, because while it is great, lots of people don’t like it.

Across the country, it’s a constant battle with better adherence. You can say that with all medical care, but the difference with CPAP is it has an integrated compliance monitoring device. So we look at this thing and we can tell exactly when the person used it. Some people abandon therapy, and roughly only half of people on CPAP have regular use of their therapy. That’s terrible.

CPAP may be great, but if people aren’t going to use it, we’ve got to have another treatment option. For us on a more personal note, we also have to maintain the fighting strength. We must be able to send people into combat.

You don’t diagnose sleep apnea, and then let soldiers go out with an untreated medical disorder. That is not good for anybody. In that case, you are taking very sleepy people and putting them in harm’s way, and you’re going to see more accidents.

How effective are oral appliances?
Lettieri: Nothing’s perfect by any means, but even half of the people with severe disease got what we considered to be adequate therapy. It depends on where you draw your line in the sand.

“We use strict criteria for what we consider to be effective therapy.  It would be hard to argue with this criteria, so most people would have to agree that adjustable oral appliances work.” If we realize that only half the people are actually using their CPAP anyway, then you’re no worse off. Even if CPAP were completely effective, half the people are not going to use it.

What do you think of non adjustable or fixed devices?
Lettieri: The problem is that you get one shot to fix them. We found that they are OK, but only for really mild disease. Anyone with moderate to severe, you need adjustable. And these are ones you can titrate, just like you do when adding a higher dose of a medication or a range of pressures with CPAP. Adjustable ones ought to be used, and are probably more cost effective in the long term because more people get adequate therapy.

What do you think of tongue control devices?
Lettieri: These are essentially suction bulbs affixed to your tongue that pulls your tongue forward. They really don’t work well—maybe for very mild disease they can be adequate. Most patients find them uncomfortable and they are not used much in clinical practice.