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 apnea in prime time

What do the television programs “Men of a Certain Age,” “Mike & Molly,” and the recently released film “Hall Pass” have in common? Obstructive sleep apnea. Principal characters in each are seen with a CPAP device. There are probably other TV shows and movies where the ubiquitous device is present, but those three come to mind quickly.

In the episode where the machine appears in “Mike & Molly,” Mike is rather matter of fact about using it and Molly is a bit put off. The laugh track rolls when she is frustrated by the fact that Mike’s mouth keeps coming open. (Where is the chin strap when you need it?)

While some people will find these representations somewhat offensive because the person wearing the mask is the object of ridicule, I have a different spin on sleep apnea portrayed on the big and little screen.

The creators/writers of “Mike & Molly”—there is probably an apneic among them—understand some portion of the viewers of the program use a CPAP, or sleeps with someone who does, or knows someone (maybe many) who are either users or partners of a CPAP user.

The use of the CPAP has become so commonplace that we can laugh about the foibles of using the device. The humor comes from “getting it” and not from thinking the wearer looks silly.

I continue to be amazed at how this condition is becoming part of everyday life—at least for some people. The challenge for me and the association is make it part of everyday life for most people.

I am ready for my close- up, Mr. DeMille....

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.

Sleep Apnea, Prevention and Healthcare reform

I am actually old school when it comes to certain things. I like to wear lapel pins on my jacket. Most of the time I wear a shiny metal pin with the association's logo. Recently I started wearing one from the Partnership for Prevention. Their pin says

It would be great to be able to prevent sleep apnea. Untreated sleep apnea is associated with a number of life-threatening condition all of which put a drag on the healthcare system.

So, preventing sleep apnea is all about the three-legged stool -

diet, exercise and sleep.

I believe that without getting the right quantity and quality of sleep - diet and exercise won't happen.

If you aren't getting enough sleep (seven and a half hours or more) and enough of the right quality sleep (stage 3 or deep and REM or dream) - then it will be almost impossible to control what you eat and have enough energy to exercise.

Practicing good sleep hygiene is one preventive measure that can insure getting enough sleep and the right kind sleep.

Unfortunately, sleep apnea is reality, an epidemic really, so preventing it by insuring people get enough sleep will require a shift in public policy concerning the value of sleep that will require a generation or two.

For those who develop sleep apnea, what does effectively treating sleep apnea mean, beyond eliminating the snoring. It could improve or mitigate certain types of heart disease and diabetes and depression and ADHD in children and even alzheimer's in older adults.

Bending the cost curve, an important component of healthcare reform, could be accomplished, in part, by recognizing sleep apnea early, before it has done serious damage. Damage that ends up costing the healthcare system, including us - lots of money.

The ASAA wrote the USPTF and requested they consider adding screening for sleep disordered breathing to their Guide for Preventive Services. If they would add some like the STOP BANG questionnaire, developed by the anesthesiologist community to screen patients prior to surgery for sleep apnea, who knows how much money could saved in healthcare cost.

I started this blog post with the lapel pin from the Partnership for Prevention

and will end with saying that sleep health is a critical component to an effective prevention strategy. Every dollar spent on understanding, promoting, encouraging healthy sleep will be returned in happier, healthier, more productive people.

When was the last time someone described what you had done as brilliant.

I have just returned from a brief trip to London where I participated in the Sleep Apnoea Trust Association's annual meeting, held John Radcliffe Hospital in Oxford (pictured here on the left).

I managed an invitation to speak at their annual meeting after a long correspondence with one of their trustees (Rob Holt) and their Chairman (Frank Govan). The ASAA has been on the mailing list of their newsletter for many years and I saw this visit an opportunity establish a personal connection with their leadership.

I had a wonderful time. Frank and his wife Wilma hosted me on the day I arrived. We had a number of long talks about operating a non-profit (read getting money) and about areas where we have mutual interests. Another guest at their home was Jean Gall who is the Chair of the Sleep Apnoea Scottish Association.

The next day was onto Oxford and SATAday (I love the name). The meeting drew about 300 people from all over England. It is similar to an A.W.A.K.E. meeting... with medical speakers (in this case Prof. John Stradling) and others from the hospital. There was an equipment fair and since there is no DME/HME arrangement in England - the manufacturers can sell direct to the patient (with proper documentation, ie prescription). Lunch was also served and there were "chatshops" or break-out sessions in the afternoon on specific topics.

I spoke in the morning session, following a presentation by Professor Stradling. My topic was OSA in the USA.

My title slide had two pictures of Jimmy Stewart. One from the Alfred Hitchcock film "Rear Window" and the second from the Frank Capra film "It's A Wonderful Life." I told the audience that many times in my capacity as executive director of the ASAA that I felt alternately like the Jimmy Stewart character in "Rear Window"; he was stuck watching a murder being committed and was somewhat powerless to do anything, I am stuck watching apnea patients not get the care they need at the hands of unethical sleep testing facilities or uncaring homecare companies (though unlike him, I don't have Grace Kelly to keep me company). On the other hand, sometimes I feel like Jimmy's character George Bailey in "It's a Wonderful Life" because despite all the bad stuff and my despair, the association has a positive influence and the apnea patient would be worse off if we weren't there.
My presentation had two objectives: providing some insight into healthcare in the United States in general and to provide some specific insights about the treatment of OSA for the American patient.

My brief discussion of the healthcare reform debate began by saying there are a number of challenges to reforming the system. The first is captured by a quote attributed to Princeton economist Uwe Reinhardt, Ph.D: Americans are the only people who think death is a failure of the healthcare system. The second has to do with the attitude towards the problem of obesity. Here I trotted out a slide that has become iconic on obesity. The audience had a good laugh on both comments.

The second part of my talk compared the way sleep apnea diagnosis and treatment are provided in the United States versus England. And while there maybe some shortcomings with the National Health Service, though less now that the National Institute for Health and Clinical Excellence has weighed in on the subject of treating sleep apnea; at least there is less chance of a patient falling through the cracks because in the U.S. in some cases the diagnosis is delivered by one medical professional and treatment is delivered/"monitored" by another possibly leading to what I called a bad Alfonse and Gaston routine.

The second point I made was concerning the technology to treat sleep apnea. The audience might feel a bit jealous that the devices available to treat sleep apnea in the United States is latest and greatest available compared to what is provided to them. But in actuality, the technology is like the bullet train passing Mt Fuji in Japan and getting ahead of the physician who prescribe them. The patients who consult the Internet learn about these devices and demand prescriptions specifying these machines, without the physician fully understanding if this is the

appropriate therapy for the patient.

My final point in this part of the talk was on adherence or compliance to therapy. For a number of different reasons adherence to therapy particularly with CPAP is not great averaging around 50%. Though this rate of adherence is comparable to adherence to therapy of other chronic diseases. That said, people are always looking for additional reason to use the CPAP... beyond that fact that it improves the quality and quantity of your life. I pointed out to the

audience the result of a recent study conducted in the U.S. showing that using the CPAP takes a stroke off your golf score and that an improved golf score was motivation enough to improve compliance with therapy... everyone wants to be Tiger Woods.

The audience was very appreciative and many made a point of coming up to me afterwords to express thanks for coming all that way to speak. They said the talk was "brilliant" and they usually had a story to share about a relative in the States.

I was happy to receive the invitation and would be happy to return at some point in the future to talk about sleep apnea diagnosis and treatment when healthcare reform is done.

Comparative Effective Study on sleep apnea

In the beginning (prior to 1978), there were two treatment options for obstructive sleep apnea: radical weight loss program and a tracheotomy. Then there was the UPPP. This was up until the introduction of Continuous Positive Airway Pressure, which according to the inventor was intended to be a stopgap treatment.


CPAP was so effective that it replaced surgery as the first line ( it became the "gold standard") treatment for OSA. Since its invention, there have been variations on UPPP using laser and ablation, which have had varying levels of success. Also introduced were other types of surgical interventions that are intended to manage the tongue.


Also developed with the intent of managing the tongue and enlarging the opening to the upper airway through moving the jaw forward are oral appliances - tongue retaining devices and mandibular advancement devices.


There are also more radical surgical procedures... breaking and moving the jaw forward and bariatric surgery.


Finally there are new therapies now the horizon such as Provent and Aura6000.

How do we establish the relative merits of these various therapies? What does it mean that they "work"? Is it the elimination of snoring and/or reduction of Apnea-Hypopnea Index and/or lowering blood pressure and/or reduced insulin resistance and/or improved psychomotor vigilance and/or improved cognitive functioning? Are we missing something if we stop at saying - four hours per night for 70% of the nights over a 30 day period.

It is difficult to measure quality in healthcare with respect to OSA if the benchmarks themselves vary from person to person.

It may be that the science of treating sleep apnea is still too young to have a specific number similar to diabetes, where if your HA1C is above or below a certain point there is a problem.

Today, I don't offer any answers. Today I only ponder.

Food Matters and Sleep Apnea

I am taking a few days away from the office and I have with me a copy of Mark Bittman's new book - Food Matters A guide to Conscious Eating - which is part ecological/dietary manifesto and part recipe book.

My inspiration for reading the book is the fact that Mr. Bittman was formerly a sleep apnea sufferer, along with having high cholesterol and being pre-diabetic.

I don't know the details of Mark's OSA, but according to him, losing the extra weight he was carrying around eliminated the apnea symptoms. Quoting him - "[M]y apnea was gone; in fact, for the first time in probably 30 years, I was sleeping through the night and not even snoring."

I think we all know, or we should be aware that the food production industry in this country is not an improvement over what existed before. Bittman's argument is, that if anything, Big Food as he calls it is fouling the air, the water and our bodies by its over reliance on meat, corn and soy.

Food Matters reinforces the argument made by Michael Pollan in his recent book In Defense of Food that Americans need to reassess our eating habits especially if we want to improve our health. Mr. Pollan's maxim - "Eat food. Not too much. Mostly plants" makes a lot of sense especially if you understand that a by-product of that way of living you can reduce your risk of heart disease, diabetes, do your joints a favor by reducing the amount of weight they need to carry and perhaps eliminate weight-induced sleep apnea.

I don't know about you, but I know that losing weight would very likely help me with a number of health issues I am currently dealing with, so I will give some of the recipes a try and see what happens.

Happy eating and more importantly happy sleeping
ED