The End of Sleep Medicine (Part 4)

 "You've come a long way baby" Virginia Slims cigarette tagline ~ circa 1968

Nearly five years since I have put pen to paper (so to speak) regarding the "end" or goal of sleep medicine. During that time I have, mostly quietly watched, the (r)evolution of the field.  I thought to provide some reflections on a field of medicine that was my professional life for 10 years. I would like also to thank again those who were my teachers and colleagues in the pursuit of helping those with the chronic health condition - #obstructive sleep apnea (OSA) - #sleep disordered breathing.

I recently had the occasion to visit a #CVS near me and found much to my surprise (though not really) the following displays

My earliest memories of serving as the executive director of the American Sleep Apnea Association was attending as an exhibitor at the #American Thoracic Society's 2004 International Conference in Orlando Florida. It was there I first met many of the men and women who would be my mentors. It was there I also met many of the reps of the device manufacturers #Resmed, #Respironics (now part of #Phillips Healthcare), #DeVilbiss, and #Fisher &Paykel.

While I was setting up the booth I had two encounters that have stayed with me. First was a woman working with the company setting up the exhibit hall. She saw the sign and stopped to tell me how her husband has #OSA. She lay beside him in the bed with her hand on his chest to make sure he was still breathing. This was my first encounter with sleep apnea - the first of what would be many during my tenure.

The second conversation I had was with a vice president for sales with #ResMed the number 1 or 2 in sales of #Positive Airway Pressure devices or CPAP.  I remember the conversation as if it was yesterday and these two images from CVS moved it to the front of my mind.  #Ron Richards said to me in five years you will be able to get these devices over the counter. If they work for you keep it (and use it) and if not bring it back. Like his boss, #Peter Farrell was fond of saying the only way one of these can hurt you is if it falls on your foot.

It took longer than five years and there are likely still a couple of hoops to jump through when it comes with the device, but at least when it comes to the supplies they are available when needed.

A second meaningful experience was the first time I provided testimony before a committee of  #Medicare regarding the use of #home sleeping testing (HST) for the diagnosis of #obstructive sleep apnea. This led to the publication of an open letter in the #Journal of Clinical Sleep Medicine.  It would be some years before the sleep medicine community would accept that #HST would not decrease the number of people seeking treatment for OSA and there would always be cases where the use of #HST would not be indicated. 

One of the many companies vying for a portion of the #HST market was a company using a different modality of measuring the incidence of pausing in breathing. #Itamar does not use the limitation of airflow into the lungs, something the pulmonary sleep medicine physicians were less inclined to accept as an accurate measure of disease. Without getting into the relative merits of the two modalities. #Itamar's technology  Here is an explanation of how this modality works.

Perhaps more important an alternate diagnostic modality was this technique engaged a medical community that heretofore had been reluctant to engage - cardiologists.  It is well known that untreated OSA has significant consequences on the cardiovascular system.  As far back as 2008 in the journal Circulation, there was the recognition that untreated sleep-disordered breathing is a driver of heart disease.  Perhaps the Itamar WatchPat technology spoke to cardiologists in a way ResMed Apnealink did not.   The important point here is cardiologists seem to be more engaged than previously.

Another memory - a well-respected sleep medicine physician would frequently say diagnosing sleep apnea as was so easy the janitor at the hospital where she practiced could tell just from looking a people in the waiting room whether they were positive for OSA.

The third and final meaningful experience happened at a medical conference where the ASAA was an exhibitor.  Our booth happened to catty-corner to that of the Board of Registered Polysomnographic Technologist (BRPST) and as it happened members of the American College of Chest Physicians happened to be passing by. The College had recently considered developing a certificate program for an allied health position for sleep, something akin to the Diabetes educator.  It was something subsequently they did not pursue.  But it was something I believed would be vital especially as #HST became more the norm than the exception.  I had always felt that successful treatment meaning being completely adherence to whatever therapy or treatment worked for the OSA patient was more important than how the diagnosis was arrived at. I knew both the representatives of ACCP and BRPST, and so I brought them together suggesting that BRPST take on the certificate program for what then call the sleep educator. It took some time and some hard work, but eventually, the CCSH program was born.

Perhaps it is fitting this blog post, the last in a series is published today on the 40th anniversary of the publication in the journal  The Lancet of Colin Sullivan's seminal research study 

Thank you to all my teachers, colleagues, and most importantly the patients who made this experience one I will always cherish.

Sleep, Sleep Apnea and the Ides of March.

The month of March has become, officially or unofficially, the month dedicated to sleep. It makes sense. For a long time and coincident with the vernal equinox we collectively (except for Arizona) adjust our clocks forward an hour to allow for an additional "hour" of daylight at the end of the work day. This adjustment occurs when we are, or should be, sleeping.

Our colleagues at the National Sleep Foundation designated the week before the time change National Sleep Awareness Week(r) and use that time to release an annual poll regarding a sleep issue.

This year, unlike previous years, there were several other important information releases during the month that bear mentioning.

On March 1st, the American Thoracic Society released a long awaited report on research priorities for ambulatory management of adults with obstructive sleep apnea. What is significant is that collaborating on the report are three of the principal medical societies responsibility for diagnosis and treatment of sleep apnea, plus the European Respiratory Society. Having everyone rowing in the same direction can only help improve the care of those with sleep apnea - here in the United States and Europe.

On March 7th, the Centers for Disease Control and Prevention published in their Morbidity and Mortality Week Report the analysis of data collected as a part of the "sleep module" from 12 states in their Behavioral Risk Factor Surveillance System (BRFSS). The addition of this set of questions to the BRFSS was due in large measure to lobbying the U.S. Congress to pay attention to sleep.  A portion of the funding granted by Congress was used to pay the expenses of the National Sleep Awareness Roundtable. 2009 was the first time the module was included and as the graphic above indicates that those getting less than 7 hours of sleep a night have a higher likelihood of snoring, unintentionally falling asleep and nodding off (!) while driving.

The watershed event of the month occurred on March 15th, when the Institute of Medicine released their report on the leading health indicators for Healthy People 2020. The IOM, at the request of the US Department of Health and Human Services distilled the nearly 600 objectives included in Healthy People 2020 down to the 24 most important. Included among the 24 was one of the four from the Sleep Health topic -  Increase the proportion of adults who get sufficient sleep. It was already significant that sleep now had its own "topic" under Healthy People. On top of that, to be included as one of the leading health indicator is a great leap forward in awareness.

March is about sleep and this year the needle moved on the importance of sleep. Now our job is not to let them forget about it the rest of the year.

Sleep apnea, comparative effectiveness and the future

The need for comparative effectiveness research follows from a recognition that we, as a country, don't have unlimited resources to expend on the delivery of healthcare; particularly as it relates to medical devices.

It makes sense for healthcare payors to pay for what works and not what doesn't. That said, there is very little incentive for innovation if the hurdle of effectiveness is so high that medical device manufacturers are reluctant to spend the money in research and development.

For those using Positive Airway Pressure therapy to treat obstructive sleep apnea, the question of comparative effectiveness can be an concern, especially when there is innovative technology available to make treatment more effective or more comfortable.

Recently I attended a breakfast meeting hosted by the publishers of Health Affairs. Their October issue of the publication was dedicated to the question of comparative effectiveness. While the entire issue is worth reviewing there was one article of particular interest to me.

Steven Pearson and Peter Bach considered a way to incorporate comparative effectiveness into the reimbursement scheme for Medicare. Quoting from the article: "Upon making a new coverage decision, Medicare would assign the service (added - heath care item) to one of three payment categories based on the evidence of comparative clinical effectiveness. After an initial three-year period, if services with insufficient evidence do not provide additional evidence demonstrating superior clinical effectiveness, payment would drop to reference pricing levels."

This strategy allows for companies introducing new technology to get three years of "dynamic pricing" and to allow for the manufacturers and clinicians to perform research to demonstrate superior effectiveness of existing therapies.

The recently published draft comparative effectiveness review on the diagnosis and treatment of obstructive sleep apnea in adults did not find compelling research to show the superiority of other PAP therapy over traditional CPAP.

How this report is used could make it harder for device manufacturers to realize a higher rate of reimbursement for more sophisticated technology. But using the scheme proposed by Pearson and Bach there could be some additional benefit pending the clinical outcome data to justify a high reimbursement.

Dr. Berwick, if you are listening... I think incorporating comparative effectiveness model proposed in Health Affairs into what Medicare will reimburse and at what rate makes a lot of sense, particularly when it comes to therapies (PAP and OAT)for the treatment of Obstructive Sleep Apnea.

ASAA Comment to AHRQ CER on Sleep Apnea

Readers of this blog know that I am concerned about comparative effectiveness research and the impact it will have on the delivery of healthcare to those with sleep apnea. The Agency for Health Research and Quality (AHRQ), the federal agency within the Department of Health and Human Services charged with comparative effectiveness research commissioned a comparative effectiveness review on diagnosis and treatment of obstructive sleep apnea in adults.

Below is our comment on the review. I have some other thoughts on comparative effectiveness and I will be back with those over the Thanksgiving holiday.

The American Sleep Apnea Association (AASA) thanks the Agency for Health Research and Quality (AHRQ) for undertaking a Comparative Effectiveness Review (CER) of diagnostic and treatment modalities for Obstructive Sleep Apnea (OSA) in adults.

Given the prevalence of the condition and the health consequences associated with leaving the condition untreated and its progressive nature, it is appropriate that an analysis be done to determine the relative effectiveness of various diagnostic tools and treatment options.

The ASAA is encouraged by the attention that has been given to sleep apnea and the recognition that the questions addressed by this review are important for the public health. It is unfortunate that, at the present time, so many of the answers are not supported by clear data, and that the AHRQ report finds most of the key questions to have low or insufficient evidence to answer. These results should be used to encourage obtaining data, and not be interpreted as there being no answer or that the question is not important.

Those preparing the review indicated a significant lack of clinical outcome data to support anything but “all cause mortality” in the patients with the severest forms of the condition. Issues such as improvement in quality of life or neuro-cognitive functioning, both very important outcomes, are supported by little evidence.

Both with respect to Positive Air Pressure (PAP) and Mandibular Advancement Devices (MAD) there was an insufficiency of evidence to address, which patients might benefit most from treatment.

The insufficiency of the evidence extends to evaluating the comparative effectiveness, the purpose of the study of the three different treatment modalities – PAP, MAD and surgery.

Despite these negative results there is confirmation of certain aspects of OSA diagnosis and treatment –

· Type III and IV “limited” channel studies are generally accurate to diagnose OSA;

· An Apnea Hypopnea Index (AHI) greater than 30 events/hr is an independent predictor of all cause mortality;

· Given the large magnitude of effect on the important immediate outcomes, such as AHI there is moderate evidence to show that PAP is an effective treatment for OSA,

· The same is true of MAD with respect to OSA in patients without co morbidities or excessive sleepiness.

The ASAA agrees with the conclusions of the CER that additional research needs to be done if the benefits of treatment using the various therapies are to be fully understood.

Given the prevalence and the health-related consequences of untreated OSA, financial resources available through the National Institutes of Health should be committed to address the future research conclusions listed in the report.

The Grey Lady speaks on Sleep Apnea, again!

As a native of Washington DC and a frequent reader of the The Washington Post it is easy to have an inferiority complex when I think of the residents of New York City and their local newspaper The New York Times.

Fortunately, the miracle of the Internet makes it possible for me to read the paper as often as I like and so I get the benefit of their excellent reporting.

The NYT has done an a great job reporting on sleep apnea... their overview of the condition is top notch -
Sleep Apnea - Symptoms, Diagnosis, Treatment of Sleep Apnea - NY Times Health Information

Yesterday, as a part of their series called patient voices, they published six accounts of people living with sleep apnea and the solutions they chose to deal with the condition -
Patient Voices - Sleep Apnea - Interactive Feature - NYTimes.com

Sleep apnea is a condition that affect millions of people in the United States and around the world. It is, I believe, a major contributor to the public health crisis that exists in this country. The Patient Voices piece helps to translate this disease from an incomprehensible number to six people. People like you and me... friends, neighbors and co-workers.

An important part of the work of awareness is making this condition real. I thank the Grey Lady for helping to raise awareness about sleep apnea by providing these stories in the voices of those living with it.

The sleep apnea smoking gun... so to speak.

I subscribe to a wonderful web service called NAPS - New Abstracts and Papers in Sleep. It provides on a weekly basis a listing of all the recently published material on sleep apnea. I commend it all the folks out there who want to keep up with research.

I received notice of an article published recently in the journal Respirology.

The title of the study "Treatment of obstructive sleep apnea in Samoa progressively reduces daytime blood pressure." I am aware of the study because one of the authors, Dr. Colin Sullivan, alluded to it when he spoke in March at an event organized by the National Sleep Foundation.

Quoting from the objective listed in abstract: "To determine the strenght of the OSA-BP relationship, this study examined the effect of CPAP in a cohort where severe OSA and under-treated hypertension coexist."

Here is the conclusion and the cool part: "Hypertensive OSA patients can exhibit large falls in BP with CPAP at 1 month, with further significant (emphasis added) reductions at 3 and 6 months. Overall, the fall in BP was proportional to the initial elevation of BP with many patients achieving normal BP at 6 months."

During his talk in March Dr. Sullivan indicated that previous studies of hypertensives using CPAP had only shown small decreasing in blood pressure. In this study, the researchers were able to take a population (Samoans) where hypertension is particularly well-treated and manage their severe sleep apnea by eliminating it using CPAP.

All previous studies had included only people with mild hypertension so the effect size (the difference treating the OSA makes) is very small and not particularly significant.

The take-away from this study and why I refer to it as a smoking gun, is treating sleep apnea can save lives by reducing blood pressure and decreasing the risk of heart disease.

Keep using your CPAP and if you are taking anti-hypertensives, keep taking them, but talk with the doctor that prescribes them to make sure you are taking the right amount.

American Sleep Apnea Association

The end of the year is fast approaching and I ask readers of this blog to follow this link for an important message from the president of the ASAA.

I will be back soon with more on getting sleep apnea on the healthcare reform agenda.

In the meantime, best wishes for the holidays,

Ed

Snoring, Calories and Sleep Apnea... ripped from the headline

It is interesting what sells newspapers or turns eyeballs on the Internet...

The results of a recent study published in the professional journal of the American Academy of Otolaryngology (Archives of Otolaryngology Head and Neck Surgery. 2008;134(12):1270-1275) presents information that people who snore burn more calories than people who don't.

Burning calories is good... if you can do it in your sleep, even better. But, if you look a little deeper you see why burning calories this way is not so good. The reason why overweight people are burning calories is that they trying to survive the equivalent of someone pushing a pillow over their face every couple of minutes while they sleep.

This would cause an increase in metabolic rate (in the form of an adrenaline rush) even in people of normal weight.

Bottom line... Read past the headline, snoring is not a new weight loss strategy.

What the news hounds missed was the announcement of a study, published in the Journal of Clinical Sleep Medicine (2008;4(6):543-550). The study involved data mining (not very sexy, but then neither is snoring) records from 278 public and 180 private hospitals in Australia.

The dataset comprised more than one and half million hospital records. Four percent - 60,197 patients had sleep apnea with the male to female ratio of 2.6:1 (holding pretty true to the numbers published by Dr. Terry Young, et. al in 1993).

The analysis of the hospital admissions (over the period 1999 to 2004) indicate that OSA patients are frequent users of health-care services with most involving cardiovascular disease, endocrine/metabolic diseases (diabetes) and other respiratory diseases.

The researchers were able plot data showing that the onset and peak occurrences of sleep apnea and obesity are the same. Two other interesting findings: that from the onset of obesity there is a latent period of five years for the development of hypertension and type 2 diabetes and 15 years for chronic ischemic heart conditions and that there is a distinct occurence peak between the ages of 55 and 59.

They say "that any press is good press" and I would tend to agree because it helps to raise awareness about a serious medical condition that affects a significant percentage of the population. But given the choice of what should get the attention of the popular media I would have to say the results of the latter study are more important than the former... with all due respect to Dr. Kezirian and colleagues.

Back soon with an Open letter to Secretary-designate Tom Daschle

Shame on Nancy Grace

Nancy Grace on her program that aired on July 9, 2007 said the following (emphasis added)-

GRACE: They said that Johnny Grunge -- Mike Durham -- he wrestled under the name Johnny Grunge, very, very well-known -- died of sleep apnea. Please. Stop. That`s basically snoring, and you know, not breathing for a few seconds periodically through the night. You don`t die of sleep apnea. That is complete BS.

It is comments like hers that makes my job so hard. When people fail to acknowledge the seriousness of untreated sleep apnea, there are those in denial that will say... it is no big deal, just deal with it.

Not only is the health of the sufferer compromised with increased risk of cardiovascular disease,hypertension and metabolic syndrome (to mention only a few), but so is the health of bed partner and other members of the family.

If you are as alarmed as I am with Nancy Grace's comment, write to her and let her know she is wrong...
http://www.cnn.com/feedback/forms/form5c.html?24

efg