The government calls it “sequestration,” but various health care sectors may soon refer to it as “slash and burn.” A report n the American Medical Association’s amednews.com sounded the alarm last week, raising the specter of a whopping half million jobs lost in 2013.

Advocates have warned throughout the year that mandatory, across-the-board spending cuts to Medicare in 2013 were set to take effect, but a study by a Pittsburgh-based research firm called Tripp Umbach has brought new urgency. According to the AMA report, the study examined the likely economic fallout of the 2% cut to the Medicare program over the next 8 years, which experts say is the result of disputes over the Budget Control Act of 2011.

The AMA’s analysis of the Tripp Umbach study concludes that the automatic budget reductions amount to between $10.7 billion and $16.4 billion in annual cuts to Medicare, and will lead to 496,000 jobs being eliminated in 2013— and a loss of 766,000 jobs by 2021.

According to Charles Fiegl, writer for amednews, representatives of the American Hospital Association, which funded the study, joined the AMA, American Nurses Association, and researchers for a September 12 briefing at the National Press Club in Washington to discuss the report’s findings. Fiegl quotes Paul Umbach, senior researcher, as saying that sequestration “would pretty much wipe out all the gains that we’ve seen since 2008” and “You pretty much see a net decrease in as many jobs that have been created.”

Physicians would reportedly not escape the effects, with 62,000 jobs predicted to disappear. The losses would stem from “hiring freezes, layoffs, holds on capital projects, and delays in other practice investments.”

Click here for the full American Medical Association report.

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The benefits of CPAP heated humidification are numerous, but why hasn’t the establishment fully embraced heated wall tubing as a way to minimize rainout? Sleep veteran Thomas K. Speer, PhD, D,ABSM, believes the answer lies in an all-too-familiar tendency of industry organizations to drag their feet when it comes to something new.

As the owner/founder of Houston-based Sleep Interpretations Unlimited, Speer works on the opposite end of the spectrum where he is quick to adapt what works. “If you look at the practice drivers at the American Academy of Sleep Medicine, they don’t even mention heated wall tubing,” says Speer. “They probably have not addressed the issue in 5 years. It’s just not on their radar.”

While Speer’s company primarily provides sleep interpretations of polysomnographic evaluations for physicians, he also works with patients and has a vested interest in finding out what works. That interest has lead Speer to several studies over the years, the latest of which explored the “effect of heated wall tubing with heated humidification on PAP usage at 30 days post CPAP initiation.” In this study, Speer acknowledges that under a variety of temperature settings the problem of condensation has interrupted sleep and lead to limited use. The study compared heated humidification using heated wall tubing in a closed system that adjusts temperature in the tube to a system that has constant temperature in the heated wall tubing under real-use conditions.

Study Methods
Study enrollment included 42 patients diagnosed with OSA who had been referred for initiation of PAP therapy. All randomly selected patients had successfully completed 30 days of usage.

Group one used heated wall tubing that was added to the system with its own power supply (Hybernite from Plastiflex Healthcare), while group two used integrated heated wall tubing with auto heat control of the humidifier (ClimateLine™ from ResMed Inc). The matched control group used an integrated heated humidifier with device.

The humidifier setting for group one and the control group was set at two.

Average daily use was statistically different between the two treatment groups and matched controls over the first 30 days of use. Average time of use for group two (ClimateLine) was 6.8 hours, while the average time for group one (Hybernite) and the controls was 5.8 hours.

Average CPAP pressure in the combined groups was 11.4 cm H2O with SD = 0.29. There were no statistical differences on general demographic parameters and severity of OSA (average AHI = 28.8 and SD=3.1).

After evaluating all data, Speer concluded that heated wall tubing could produce improved adherence to PAP therapy. However, temperature and humidity at the interface affect overall usage.

Hybernite Improves with Humidifier Setting
Speer determined that the Hybernite’s performance could be attributed to the humidifier setting. “When you have the humidifier set at two, there is not enough heat from the plate to make it that much different then the control,” explains Speer. “We had the ResMed ClimateLine on the auto setting, which means the heated plate would increase and decrease automatically based on a hose setting at 82 to 85 degrees.

“In a follow-up, we increased the temperature on the Hybernite from two to four, and we got much better results,” continues Speer. “The takeaway is that most people don’t turn the humidifier up above two.”

The existence of both brands points to the fact that people need humidification and rainout must be controlled for maximum compliance. “If you take away humidity, you are going to have to increase pressure because of nasal resistance over time,” says Speer, who also serves as a sight visitor for AASM accreditation. “If you increase humidity without rainout, you lower pressure and increase usage. That is a great combination.”

Large Corporations Bring Marketing Muscle
With ResMed and Respironics throwing their hats into the heated tubing ring, awareness is bound to grow. While Speer believes that added visibility is a good thing, he is also convinced that smaller companies such as Plastiflex Healthcare’s Hybernite can ultimately compete.

Other companies such as Fisher & Paykel have invested in heated tube technology, but the largest corporations will inevitably transform the market. “Everybody else that makes a box is going to have to find a way to put heated wall tubing on it just to compete,” muses Speer. “For the moment, there is a reimbursement differential for heated wall tubing. That is, you can make more money with it. And if you generate more money with something, it will probably thrive.”

The Big Picture
Speer laments that the sleep field has not historically done well with compliance, and the big issue is usually nasal dryness, dry mouth, and oral breathing—especially now that CPAP pressures are increasing. Ultimately, CPAP borrowed from another piece of technology. “Ventilators have been using heated wall tubing for 20 years in the ICU,” says Speer. “When it became available with ResMed’s S9 platform, it was not available for other units. Plastiflex came along and had a universal heated tubing that could be added to any device. The resulting Hybernite is cost effective to the patient and delivers a positive outcome.

Ultimately, heated tubing is another option, one of many, that can boost crucial compliance rates. More options, says Speer, will lead to more patient diversity. “The average patient in the sleep labs is an overweight male in his 50s with comorbidities,” he says. “Various things such as provent therapy and oral appliances are of value in getting these patients into the stream of treatment. I’ll use breathe right strips or whatever it takes to get a patient into treatment. There is no need for turf wars. This is about helping patients and there are plenty of patients to go around.”

Thomas K. Speer PhD, D, ABSM began his sleep medicine practice in Houston in 1992.  He was the director of the Institute of Sleep Medicine at the Diagnostic Clinic and has served as the director of Sleep Centers of Texas.  For the past ten years, he has had his own practice, focusing on therapies for sleep apnea and other therapies for insomnia (cognitive behavioral therapy – insomnia), CPAP desensitization and support, and circadian rhythm disorders, including bright-light therapy. He is a Fellow of the American Academy of Sleep Medicine and has been an accreditation site visitor for the Academy since 2007.  He is board certified by the American Board of Sleep Medicine and is licensed as a psychologist by the Texas State Board of Examiners of Psychologists and a member of the American Psychological Association since 1988.

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Untreated severe OSA is associated with an increased risk of cardiovascular mortality in the elderly, and adequate treatment with CPAP may significantly reduce this risk, according to a new study from researchers in Spain titled “Cardiovascular Mortality in Obstructive Sleep Apnea in the Elderly, Role of Long-Term CPAP Treament”.

“Although the link between OSA and cardiovascular mortality is well established in younger patients, evidence on this relationship in the elderly has been conflicting,” said lead author Miguel Ángel Martínez-García, MD, of La Fe University and Polytechnic Hospital in Valencia, Spain. “In our study of 939 elderly patients, severe OSA not treated with CPAP was associated with an increased risk of cardiovascular mortality especially from stroke and heart failure, and CPAP treatment reduced this excess of cardiovascular mortality to levels similar to those seen in patients without OSA.”

To read the article in full, Click Here (With an impact factor of 11.080, the AJRRCM aims to publish the most innovative science and the highest quality reviews, practice guidelines, and statements in the pulmonary, critical care, and sleep-related fields).

All subjects in this prospective, observational study were 65 years of age or older. Median follow-up was 69 months. Sleep studies were conducted with either full standard polysomnography or respiratory polygraphy following Spanish guidelines. OSA was defined as mild-to-moderate (apnea-hypopnea index [AHI] 15-29) or severe (AHI ≥30). Patients with AHI <15 acted as controls. CPAP use ≥4 hours daily was considered as good adherence to treatment.

Visit the American Thoracic Society webiste

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Compromised health affects Americans in countless ways, not the least of which is sleep deprivation. The price tag in lost productivity can hit a staggering $100 billion annually thanks to medical expenses, sick leave, and property damage. The National Highway Traffic Safety Administration estimates that more than 70,000 injuries each year are related to drowsy drivers.

There are many causes of sleep disruption, and patients rarely exhibit just one. Simply addressing sleep disordered breathing (SDB) may not result in good long term sleep. Other issues can range from an inferior mattress, a disruptive sleep environment, the wrong medication, pain, incorrect positive airway pressure (PAP), and insomnia.

As a result of these staggering numbers and the increasing awareness of sleep disorders, it’s reasonable that sleep should be one of the “vital signs” of health, together with temperature, blood pressure, respiration rate, pulse, pain, and BMI (body mass index).

Adequate sleep has been defined as regularly sleeping 6-8 hours per night. Clinicians now believe that sufficient slumber is a critical factor in health and health-related behaviors across all ages. It is not enough to simply spend these hours in bed. The quality of sleep is just as, if not more important than, the quantity.

Defining Quality Sleep

How is quality of sleep defined? For the sleep specialist, “good” sleep may be defined as sleep that has normal efficiency, organized sleep architecture, and the absence of any sleep disruptions. For the patient, good sleep may mean waking up in the morning feeling refreshed and not feeling sleepy during the day.

How do we currently measure “good sleep?” One way is with an in-lab PSG test, which is often necessary but also expensive. A second way is through home sleep testing (HST), although most of these devices measure parameters that only detect sleep apnea. A third, purely subjective way we measure sleep, is to simply ask patients how they are sleeping. This last approach is akin to asking them whether they feel heavier or lighter instead of having them step on a scale.

In addition, if your patients have never slept well, how do they know they slept well last night versus sleeping a bit better than the night before? This leaves us with the sleep lab but how can we expect a patient to sleep “normally” and collect a representative night of sleep quality when there are so many cables and equipment attached to them, not to mention we are asking them to sleep in a strange environment – with a camera watching them all night – which takes us back to home sleep testing.

Cost Effective and Objective

All of this information points to the need for a simple and objective measure of sleep quality that is cost effective enough to use on patients regularly without being specific to a particular condition, in much the same way a scale will objectively measure weight. What’s needed is a “scale” that objectively measures sleep quality or sleep health.

Enter Robert Thomas, MD, and his colleagues at the Beth Israel Deaconess Medical Center, a teaching school of Harvard Medical School, who have taken a different approach to examining sleep—seeking to objectively measure sleep quality using cardiopulmonary coupling (CPC).

The principle behind this technology is the understanding that stable NREM (non-rapid eye movement) sleep is characterized by a cardiac rhythm known as sinus arrhythmia. During stable sleep, high vagal tone modulating a healthy heart results in characteristic heart rate variability in which the heart slows and speeds up in synchrony with very regular respiration. This is what Thomas calls stable sleep.

But not all heart rate variability is synchronized with normal respiration. Repetitive sleep disruptions, which could be caused by SDB, pain, a noisy sleeping environment, periodic limb movement syndrome (PLMS), restless legs syndrome (RLS), or anxiety, to name a few, can cause the heart rate and breathing rate to vary. This bradytachyarrhythmia is well recognized in polysomnograms.

These recurring disruptions can be seen as infrequently as once every 2 to 3 minutes, or as often as 1 to 3 times every minute, so they are difficult to see in a normal PSG test. How- ever, if we look at the data in terms of frequency we can see these changes occurring over sometimes long periods of time. It’s like being too close and not seeing the forest for the trees. This is unstable sleep.

Thomas also identified that there is little overlap between stable and unstable sleep, so they can be easily displayed and differentiated from each other. This makes interpretation much easier. The concept of stable and unstable sleep is central to CPC.

The result of Roberts’ CPC is a new, low cost, patient centered system call SleepImage that measures stable vs. unstable sleep. This test-anywhere device weighs less than an ounce, sits barely detectable on the patient’s chest, and also records actigraphy, body position, ECG, and snoring. It is fully integrated with a secure website and delivers a simple and easy-to-understand “picture of sleep” that identifies stable and unstable sleep to produce an objective measure of sleep quality.

There are many practical uses for the device, and because of its simplicity, researchers have been able to expand the iden- tification and understanding of sleep beyond conventional sleep diagnostic practices. In the sleep lab, the CPC technology can be used to help identify complex sleep apnea, a disorder that may make conventional CPAPs intolerable for patients.

As a home sleep test, the SleepImage system can be used as a very low cost screener for patients that complain of poor sleep. The SleepImage will quickly and cost effectively validate whether an in-lab PSG or some other course of action is nec- essary and more importantly allow the physician to monitor sleep quality after intervention to ensure that the patient is complying with therapy or if there is another co-morbid condition that is continuing to cause poor sleep quality.

Perhaps the most noteworthy benefit of this technology is its ease of use, requiring little or no instruction to the patient, with automated analysis and easy-to-understand graphic results.

SleepImage is FDA cleared, and affords an objective measure of sleep quality that not only provides a picture of your patient’s sleep, but also assists in tracking sleep trends over time—offering an accurate measure of the effectiveness of a given therapeutic choice. So the next time you ask pa- tients how they slept last night, why not have an objective way to validate the answer?

For more information about SleepImage you can go to SleepImage.com

David Baker became involved in sleep when he led the creation of the Sandman PSG system in 1992 and its ongoing development for 8 years, before joining a sleep lab company in Arizona which ran about 8 labs in the South West. In 2005 David was recruited to run the Embla company, a sleep equipment diagnostic company, and SleepTech, a sleep services company with 18 sleep labs throughout the US David led Embla through the purchase of the Sandman system in 2009 and then the sale of Embla to Natus in 2011 and SleepTech to a venture group in 2012. David is now CEO of MyCardio, the exclusive distributor of the CPC technology based in Broomfield Colorado.

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Margaret Moline, PhD, recently provided additional clarity about gender-specific dosing for Intermezzo, the Purdue Pharma drug that addresses middle-of-the-night insomnia.

Intermezzo* (zolpidem tartrate) sublingual tablets are currently approved for use as needed for the treatment of insomnia when a middle-of-the-night (MOTN) awakening is followed by difficulty returning to sleep. Many sleep physicians already know that Intermezzo is indicated for the treatment of MOTN insomnia when the patient has at least 4 hours of time in bed remaining.

Gender-specific doses are recommended, but many clinicians may not understand the clinicial support for the efficacy of 1.75 milligrams for women and 3.5 milligrams in men. Margaret Moline, PhD, set about to clear this up with a poster presentation at SLEEP 2012—the 26th Annual Meeting of the Associated Professional Sleep Societies (APSS).

“This is a new set of analyses that we performed on data that were already published,” said Moline, director, Medical Research, Purdue Pharma Inc, Stamford, Conn. “The original analyses were based on the entire patient population, and not broken down by gender.”

In November 2011, when the FDA approved the drug, they stipulated gender-specific dosing, but few clinicians understood the “why” of the government’s decision. “When you are evaluating drugs for approval, it’s important to take into consideration the entire package of efficacy and safety,” said Moline during a discussion of her poster titled “Gender Effects of 1.75 mg and 3.5 mg Zolpidem Tartrate Sublingual Tablets Formulated with a Carbonate-Bicarbonate Buffer on Sleep Onset Following Middle-of-the-Night Awakening and on Next-Day Residual Effects”. “There were two pivotal trials, and this trial we are reporting on for the poster tested two different doses — 1.75 milligrams and 3.5 mg.”

Method
Moline’s analyses specifically investigated the 1.75mg and 3.5mg zolpidem tartrate sublingual tablets (Intermezzo^®), formulated with a carbonate-bicarbonate buffer.

Post-hoc analysis was performed to examine response by gender in this double-blind, placebo-controlled 3-way cross-over study in patients with a diagnosis of primary insomnia as defined by the DSM-IV-TR and a history of prolonged MOTN awakenings. Patients had a history of MOTN awakening with difficulty returning to sleep and had to demonstrate polysomnographic (PSG) mean latency to persistent sleep of ≥20 minutes following scheduled awakenings on screening nights.

Treatments consisted of 2 nights of dosing followed by a 5- to 12-day washout. Fifty-eight female and 24 male patients were randomized. Patients were awakened and dosed with 3.5 mg, 1.75 mg or placebo 4 hours after lights out, kept awake for 30 minutes, then returned to bed for 4 hours. Time to return to sleep was assessed by PSG and post-sleep questionnaires. Residual effects were measured by objective/subjective measures.

Results
In both genders, compared to placebo, both the 3.5 mg and 1.75 mg doses of Intermezzo significantly decreased sleep latency based on PSG and post-sleep questionnaires. Following the 1.75 mg dose, 60% and 44% of the females and males, respectively, were asleep within 20 minutes. The rates following the 3.5 mg dose were 80% and 63% in females and males, respectively. Placebo response rates were significantly lower: 26% (females) and 33% (males). Neither dose in either gender showed significant residual effects compared to placebo based on the assessments performed during the study.

Conclusion
These data demonstrated that Intermezzo was effective in reducing time to return to sleep in MOTN insomnia without producing residual effects. Further, the effects of 1.75 mg in females and 3.5 mg in males were comparable. This gender-specific related dosing is consistent with previously reported differences in zolpidem pharmacokinetics.

PSG and patient-reported measures indicate that Intermezzo  doses of 1.75 mg and 3.5 mg significantly shortened time to return to sleep and improved total sleep time in MOTN insomnia, and that the effects of 1.75 mg in females and 3.5 mg in males were comparable.

Minimal residual sedative or other adverse effects were observed with Intermezzo versus placebo, and there were no differences between females and males on any parameter.

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* Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.

Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after the 1.75 mg dose in women, and after the 3.5 mg dose in men, such that a potential negative effect on driving cannot be completely excluded.

The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. Angioedema and additional symptoms suggesting anaphylaxis may be fatal. Patients who develop angioedema or anaphylaxis should not be re-challenged.

Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic, including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as “sleep-driving” have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a “sleep-driving” episode.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional over dosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.

Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.

The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue.

For additional information, please read the Intermezzo Full Prescribing Information available at http://app.purduepharma.com/xmlpublishing/pi.aspx?id=i

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