One of the unique, if not peculiar aspects of managing patients on PAP therapy is that no standard model of medical care exactly matches our unusual and perceived as cumbersome or invasive treatment modality. Previously, we have talked about the common comparison of adjusting the dosage of a medication, as in the example of a diabetic or someone with depression who might need repeated medical visits, especially in the early stages of finding the right medication while concurrently fine tuning the dosage of the medication(s). Various steps often include the timing, the frequency of medication use, the amount of medicine, the variance of amount of medicine by time of day or other circumstances tailored to the individual patient, and of course the predictability of side-effects and how to take steps to prevent or overcome them. Such a process is usually called “medical management” of a disease process, and for the most part requires the doctor and patient to meet in person or talk by phone or through other means of personal communication.
PAP therapy has some of these elements, and we often start with preventing or overcoming side effects due to mask issues, which over time might require repeated encounters with the DME staff, sleep center staff or the sleep specialist. In some situations, early and aggressive follow-up might overcome mask issues and give the patient sufficient confidence to forge ahead into the territory of regular use or as the insurance companies call it, “compliance” or “adherence.” Yet, even these encounters are quite different than most medical management appointments, because the physician may never need to lay hands on the patient to treat diabetes or depression, other than to perform a cursory and sometimes irrelevant physical examination. The discussion between doctor and patient leads the physician or other prescribing provider to make the appropriate adjustments. Whereas, in the vast majority of medical encounters for mask adjustments, the sleep tech or sleep specialist are manipulating elements such as various masks styles, chinstraps, mask liners and so forth. And, if the sleep professional is not skilled in working manually in this way and simply imagines the process can be talked through, the outcomes are usually far worse than if someone is literally placing the mask on the patient’s face and then having the patient demonstrate efficacy via repeated re-fittings.
So, to be clear, dealing with PAP obviously has a lot more hands-on to it than traditional medical management, and I would offer that a closer and more accurate analogy might be medical procedures or therapies that involve more invasive or at least hands-on medical encounters. One of the most common medical visits of this type would fall into the category of physical therapy, where the individual is recovering from surgery or an injury, or they may be suffering from chronic pain or range of motion problem. In this area, it is rare to see the physical therapist one time. Rather, there is a stepwise process, combining analysis and instruction, after which the patients does his “homework” and practices the manipulations, stretches, or other strengthening steps and then reports back to the therapist. The PT then re-analyzes the progress and subsequently adjusts or fine tunes the instructions. This process unfolds as often as twice or even three times per week depending upon the severity of the condition. Over time, it drops down to once per week and then twice per month, but it would be unusual for the treatment manipulations to not continue for weeks or months on end until the optimal response was achieved.
We can examine other medical interventions on a spectrum from somewhat invasive to highly invasive. Akin to physical therapy, many patients with aches and pains or musculo-skeletal problems make regular use of chiropractic services. Another area of interest would be orthodontics, a process that frequently requires one to two years of intervention, and during which repeated adjustments are required either to alleviate painful side-effects or to promote the corrective dental shaping of the upper and lower arches. Still more invasive would be cardiovascular procedures, and the two most obvious would be the implantation of pacemakers to protect against dangerous arrhythmias or the use of electrophysiology intervention studies (EPS) to eliminate arrhythmias altogether.
The course of EPS treatment for arrhythmias is similar to failed CPAP treatment, because we know that EPS often eliminates atrial fibrillation in the early post-procedure period, only to have the arrhythmia return in as a little as a few days to a few months. In fact, looking at a PubMed search, there are nearly 1000 articles on the problem of early recurrence (ER) of atrial fibrillation, which is just one of the arrhythmias treated with EPS. The similarity here is that a huge number of CPAP patients often report a great response initially but within a matter of weeks or months, they then notice a steady decline, which leads them to believe either something must be wrong with the machine or perhaps they’ve been given the wrong treatment altogether. In the case of a failed EPS treatment where the atrial fibrillation returns, it is not an automatic return trip to the catheterization lab (see more here to learn about EPS studies). However, a return to the cath lab does occur for many patients, because the technology is so advanced there is a very good chance to achieve a successful and more lasting outcome.
If you can imagine the basics of an EPS study, a catheter with special sensors on the end is inserted through a large vein in the body and threaded all the way into the heart chambers to map out areas where the heart’s electrical signals control the beating of the muscle. A regular rhythm (known as normal sinus rhythm) can easily be observed on a simple EKG, but if a patient develops an arrhythmia, the EPS technology can determine whether or not an area of affected heart muscle can be “treated” (ablated) in such a way to prevent the irregularity in the heart’s electrical signals. While there may be certain risks involved in the procedure, cardiologists will often discuss the value of a return trip to the cath lab in a patient with ER (early recurrence of atrial fibrillation after the first ablation study). Usually, a patient is motivated to move forward with the 2nd study, because not only has the problem of atrial fibrillation returned but also all the associated symptoms such as fatigue, low energy, dizziness and worse may re-emerge as the heart can no longer pump the blood consistently due to the irregular rhythm.
Just so with OSA/UARS, a person may or may not receive early benefits, but regardless most patients undergo at least one follow-up encounter through the DME or the sleep center where a poor responder is likely to complain about the lack of benefits.
What should be done in this situation varies across sleep centers and DME companies, but the general perspective held by the vast majority of sleep professionals is to work through daytime appointments to correct assorted issues. The most common ones might be mask leak, mouth breathing, mask pain, mask discomfort, skin irritation or the big one of pressures feeling too high or too forceful. What’s ironic about these scenarios is the belief that the technology only needs to be corrected in hands-on ways that do not rely on precise quantitative means. In other words, take the example of mask leak, suppose a sleep tech or a DME staff changes the mask on a patient. Logically, we would expect there to be a testing of the change. Yet, many facilities do not arrange for the patient to lie down in a sleeping position, position the new mask and then turn on the pressure so that the elimination of leak can be confirmed. Instead, it’s all on the patient to go home and sort out the leak issue through additional trial and error.
Even if we accept the assumption that it’s costly to return someone to the sleep lab for EF (early failure) due to mask leak, we should all be capable of appreciating that bringing the patient back to the sleep lab is the most accurate way to measure the changes in leak with a new mask. And, most importantly, throughout the night for the duration of the study, the mask leak can be monitored every step of way in NREM or REM sleep, in supine or prone sleep, on left-sided or right-sided sleep, and even when the patient is awake or sleep, or having leg jerks or not having leg jerks and so on.
This accuracy is exactly what you would expect for an EPS study, and it’s exactly what you get. An EPS is arguably a more advanced and delicate procedure, and as such we are not surprised that it may cost several thousand dollars, while lasting anywhere from one to a few hours. A sleep study lasts the whole night, and in most areas of the country, we would be lucky to get a thousand dollars for a study. Setting price aside, though, the real issue is whether or not a sleep apnea patient has the right to expect greater precision in treatment options?
This point is key because the movement continues to build towards preventing patients from ever visiting the sleep lab for an overnight study. In my travels, and most notably on the east coast, I meet many individuals with OSA who have never been in a sleep lab despite struggling with CPAP devices for months or years. Indeed, many report they were unaware of such an option. They are told to accept the system that says use an APAP mode, and the only followup permitted is the tweaking of settings that might occur based on changes in outcomes or lack thereof.
Each of the additional items listed above, including mouth breathing, mask pain, mask discomfort, skin irritation or the big one of pressures feeling too high or too forceful, are all managed in the same way in the conventional wisdom approach to sleep medicine care. Instead of precision responses to rectify the problems, the patient receives hands-on responses without any of the sophisticated measuring capabilities of the sleep lab. The silliest of these misadventures occurs with mouth breathing, because it is nearly impossible to detect the extent and impact of mouth breathing without observing the problem first-hand in the sleep lab. Even then, some sleep professionals teach their sleep techs to avoid entering the bedroom for fear of waking the patient. Yet, the only way to observe mouth breathing accurately is by having the sleep tech quietly step into the bedroom.
When a tech observes mouth breathing, all sorts of details can be reported, many of which subsequently lead to more precise adjustments. Is it positional (e.g. supine), due to a certain stage of sleep (e.g. REM), related to mask slippage, related to wrong mask, related to wrong size mask, or does it emerge directly after a leg jerk? In other words, lots of highly accurate and precise information can be garnered by the direct efforts of a sleep tech watching the process, akin at some level to an interventional cardiologist attempting to map out the damaged cardiac muscle causing the arrhythmia.
PAP pressures are the ultimate in direct hands-on fine tuning, and the results are often dramatic when a patient is properly titrated to effectively round both the inspiratory and the expiratory limbs of the airflow curve. It is virtually impossible at least in any sense of timeliness to discover the optimal pressure settings by trial and error at home. No doubt settings can be moved in the right direction that fosters improved outcomes, but this process does not attempt or even acknowledge the potentiality of a completely normalized breathing pattern. As with an EPS study that would seek to eliminate (ablate or deactivate) all cardiac tissue that triggers atrial fibrillation, the end result would be normal sinus rhythm all the time or as much of the time as possible. Normal sinus rhythm generally speaking shows a consistent pattern, although other components of heart disease may affect the shape of the heart tracing.
When we approach the problem of normalized airflow during sleep, we presume this target is the most appropriate pathway forward, despite the conventional wisdom from the American Academy of Sleep Medicine that only mandates the elimination of breathing events without ever itemizing what it means to normalize the airflow curve.
In terms of medical seriousness (our ultimate way of comparing two different diseases), there are many consequences caused by untreated atrial fibrillation as well as from many other cardiac arrhythmias. Some of these adverse effects lead to serious health problems and sometimes mortality. Though many specialists in sleep medicine tend to be shy about equating the seriousness of sleep health to the seriousness of heart health, inadequate treatment of OSA/UARS is a very serious problem that largely goes unrecognized or is routinely underestimated by many medical professionals throughout numerous non-sleep related fields of medicine. Some of the more common fields that ignore this perspective would be psychiatrists and other therapists in evaluating treatment resistance in several mental health disorders, urologists in assessment and treatment of nocturia, nephrologists in managing chronic renal failure, and even some cardiologists in managing assorted cardiovascular conditions.
Upon examination of the field of sleep medicine, as written about in prior posts on this blog, it is a very serious matter when the airflow signal is not properly normalized for much of the night, because the individual could experience additional trips to the bathroom, thus increasing risks for falls during the night. If a patient has dropped their trips to the bathroom from three per night to two on an APAP device while using its default pressure settings, why wouldn’t sleep professionals want to explore the possibility of dropping the trips to the bathroom down to once per night or not at all? Not only do most sleep specialists ignore this possibility, that is, they refuse to place their patients in the sleep lab to fully normalize the airflow signal with the optimal pressure settings, but also, they may be ignorant of the fact that nocturia (trips to the bathroom at night) may be decreased further or eliminated entirely just by making further treatment gains in the management of sleep-disordered breathing.
Sadly, I have had this conversation on these specific points with a number of sleep professionals, including physicians and sleep technologists. Most of them buy into the conventional wisdom that since everyone seems to go to the bathroom at night, it’s probably normal to go once or twice. By embracing this conventional wisdom, the medical provider does the patient a great disservice by assuming nocturia is not directly related to OSA/UARS.
We discovered the deeper connection between normalized airflow and elimination of nocturia in our quest to understand why fixed pressure CPAP was not providing excellent to outstanding responses in our patients. When we first made the switch to BPAP in 2005 and learned about the possibility of normalizing the airflow curve, the patients reported greater improvements in daytime sleepiness and fatigue as well as fewer episodes of nocturia. As we continued in advancing our systems to ABPAP in 2008 and then ASV in 2010, we saw that persistent, aggressive attempts to normalize the airflow curve led to greater improvements in sleepiness and fatigue and fewer nocturia trips.
The most surprising and alarming aspect of our findings is the pervasive lack of curiosity among other sleep physicians to at least become somewhat curious as to why so many patients fail CPAP. It appears that many sleep professionals simply accept CPAP failure is par for the course. Because technological advances with PAP are not routinely studied in research investigations, and because the research is almost never conducted to manually titrate these advanced devices in the sleep lab, our field has been stuck in first gear for decades, searching for CPAP failure factors everywhere but inside the sleep lab.
Forgive me if I offered this old Sufi adage previously about the Nasrudin character who comes upon a man searching frantically for his keys outside his home. After Nasrudin joins the search, but to no avail, he asks the man, “do you recall where you lost the keys?” The man responds “inside my house.” A perplexed Nasrudin queries him back, “So, why are we looking out here?” To which the senseless man replies, “because there’s more light.”
This lack of curiosity is literally causing a great deal of morbidity and mortality among sleep patients, because they go untreated for failing to be able to use CPAP or using it but failing to gain notable benefits from it. And, instead of their sleep physicians acting in accordance with how a cardiologist evaluates and treats the re-emergence of atrial fibrillation after an EPS study, the typical OSA/UARS patient receives no such support.
So, let us be very clear again on what these points mean. If patients are suffering from poorly controlled hypertension and are failing CPAP, then everything points to the facts that they have greater risks for strokes, heart attacks and other cardiovascular events. If such patients are already on multiple medications for hypertension and still suffering from poor control, then failing CPAP puts them at still greater risk, because their medical management appears to be maxed out. Some of these patients will die, some will suffer heart attacks and some will suffer strokes. All these patients might have had a second or third chance if they were permitted to visit or return to the sleep lab (the latter if they were lucky enough to start off on in the sleep lab), during which they could receive the same degree of precise care as a cardiologist working with a case of a failed EPS study. By normalizing the airflow curve with precision techniques, some of these patients would adapt to advanced PAP; and, in becoming regular users they would most likely experience greater control of their blood pressure, all of which would decrease their risks for other unhealthy outcomes.
The above paragraph could be repeated nearly verbatim for elderly people with nocturia, a leading if not the leading cause of falls, broken hips, and potentially mortality in this population. When their sleep facilities do not make the effort to provide a high level of care to normalize the airflow signal and thereby decrease the trips to the bathroom, risks increase for all these bad outcomes.
The above paragraph could be repeated for depressed patients who have tried multiple psychotropic medications for depression and are now labeled treatment resistant depressed patients. Not a small proportion of these patients also may suffer suicidal ideation and behaviors, and although the vast majority never commit suicide, the burdens they suffer from and the extensive healthcare services they require are clearly problematic to friends, family and healthcare providers. Research is somewhat prevalent on OSA/UARS and depression and rarely (but not non-existent) on suicidality and OSA/UARS. When psychiatrists and therapists fail to refer their patients to sleep centers, and worse when these patients are referred but then the sleep professionals refuse to evaluate for sleep-disordered breathing, the misery and suffering continues and unequivocally leads to greater morbidity and potentially mortality. Such patients never even have a shot at advanced PAP devices, because they’re often persuaded that CPAP would prove intolerable.
If you look closely at many fields of medicine where sleep disorders often surface in patients otherwise not viewed as sleep patients and we combine this problem with the high level of mediocre care among many sleep centers that solely fixate on CPAP, it is clear we are under-serving our patients. The wake up call needed here is the dire necessity to bring back patients into the sleep lab in order to receive advanced testing services, just as would be the case for virtually any cardiac patient.