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General Discussion on any topic relating to CPAP and/or Sleep Apnea.
FrederickRose
 
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Assessment of treatment efficacy

Postby FrederickRose on Wed Nov 08, 2017 12:55 pm

This post is going to be related to the other recent thread by xxyzx, so moderator please merge if appropriate.

As some of you may have seen in my earlier thread, I was recently self-diagnosed with OSA and have been trying to find the right PAP settings. I've learned a lot here and on other forums.

One of the things I'm not clear on is how to assess treatment efficacy. Broadly speaking, I understand that the goals are to feel better and to be healthier, but what I remain uncertain about is how to assess whether those goals have been achieved.

For one thing, I didn't feel terrible prior to PAP. I do feel better since starting PAP, but I'm not sure how much better I am supposed to feel. I've never had terrible daytime somnolence or other really severe symptoms.

I'm a physician and have been reading the medical literature, and there seems to be no real evidence based consensus about how to judge the adequacy of treatment. In particular, the type of data we review here in the forum, as reported by our machines, seems not to be of primary consideration amongst those who publish in reputable journals in the field.

UpToDate, a commonly used physician reference for evidence-based medicine states the following about assessing treatment efficacy (authors are Meir H Kryger, MD, FRCPC, Professor of Medicine, Yale University; and Atul Malhotra, MD, Professor of Medicine, University of California, San Diego):

Once any side effects of the positive airway pressure are successfully managed and the patient is adhering to the therapy, the patient should be asked whether the symptoms of OSA have resolved. In addition, objective data on compliance and effectiveness can be downloaded from the patient's device and reviewed, although studies on the accuracy of the information are mixed. An objective sleep evaluation is generally unnecessary if the symptoms of OSA have resolved, but repeat testing is indicated for patients who do not improve or who have recurrent or persistent symptoms such as daytime sleepiness [1]. Objective testing may consist of polysomnography or type 3 home sleep apnea testing (HSAT) with concurrent CPAP use. (See "Home sleep apnea testing for obstructive sleep apnea in adults" and "Adherence with continuous positive airway pressure (CPAP)", section on 'Identification'.)

The purpose of such testing is to help the clinician determine the reason for the treatment failure. Possible causes of treatment failure include nonadherence or suboptimal adherence, weight gain, an inappropriate level of prescribed positive pressure, or an additional disorder causing sleepiness (eg, narcolepsy) that may require alterations in the therapeutic regimen. A review of medications should also be undertaken since many drugs may lead to sleepiness. Inadequate sleep time may also negate the expected effects from treatment of OSA.


As you can see, there is nothing there about looking at the data from user PAP machines. Furthermore, there is no recommendation to look at any measured data to gauge treatment efficacy unless symptoms remain present.

This letter to the editor titled "The SLEEP GOAL as a success criteria in obstructive sleep apnea therapy" offers an interesting perspective , IMO: https://link.springer.com/article/10.10 ... 016-3944-2

Excerpt:

There is a mountain of evidence showing how the AHI can vary from night to night, vary from laboratory to laboratory, from various nasal thermistor to pressure transducers, and AHI can vary based on the different definitions of hypopnea used in different laboratories and software [6, 7, 8, 9, 10, 11, 12, 13, 14]. The contemporary reliance on AHI as generally the only outcome measure assessed in research programs is not in line with many other aspects of medicine that are becoming patient centered as opposed to test centered [6, 7, 8, 9, 10, 11, 12, 13, 14].


For someone like me who feels "better" and has a user machine-reported AHI under 5, there seems to be forum consensus (in multiple forums) that using higher pressure settings to get the AHI even lower is worthwhile. From what I can find in the medical literature, I am not seeing evidence for such an approach. On the one hand, the health benefits of lowering the AHI further — even if we assume that the machine is correctly reporting AHI — seem to be uncertain. On the other hand, the long-term consequences of using higher pressures also seem to be uncertain.

To give a simple example, if we assume that my symptoms are well controlled, is it more desirable for me to use CPAP 14 with an AHI of 0 (data averaged over multiple days of therapy) or CPAP 10 with an AHI of 4? As far as I can tell, we are lacking high quality data to support one answer or the other. That is without even considering all the other measurable parameters other than AHI, which as xxyzx pointed out, may be highly relevant to gauging treatment response.

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Re: Assessment of treatment efficacy

Postby Julie on Wed Nov 08, 2017 2:29 pm

These links will tell you all about Sleepyhead, the software used by so many here and elsewhere, that gives a lot of detail about your sleep and lets you track what goes on overnight. It has many features and there's info about how to post the results. Please take time to read it all and experienced members here will help you interpret things. And please don't take anything Xxxyz says - no matter how authoritative it seems - seriously at all. He is quite disturbed but due to the owners here not believing in moderators, has been allowed to invade most threads with his ignorant and nonsensical stuff. Sorry!

https://sleep.tnet.com/sleepyhead
https://sleep.tnet.com/resources/sleepyhead/shorganize
https://sleep.tnet.com/reference/tips/imgur
Last edited by Julie on Wed Nov 08, 2017 3:01 pm, edited 1 time in total.

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Re: Assessment of treatment efficacy

Postby Pugsy on Wed Nov 08, 2017 3:03 pm

We as humans seem to need some sort of number validation for a lot of things when it comes to medical stuff.
We have normal ranges of just about everything out there and we like for our "numbers" to be with the norm.
When it comes to the OSA number stuff...I try to look at the big picture and not just a particular set of numbers but of course we have to start somewhere so numbers is where we start.

I look at the composition of the AHI and not just the single AHI number. If the AHI is composed primarily of central apneas more pressure isn't going to lower that number so there's no sense in going from 10 cm to 14 cm (using your example). More pressure won't reduce the number of centrals.
Now it might reduce the number of OAs or hyponeas but it also might not. I once did an experiment where I went from 10 cm minimum to 13 cm minimum in 0.5 cm increments spending a week at each setting. My overall AHI never really reduced with the increase in pressure even at 13 and I wasn't having centrals either. Since my "numbers" didn't really change and I didn't feel any different and didn't sleep any different then I went back to 10 cm minimum. It was simply more comfortable to start at 10 than at 13 and if there's no urgent need to do 13 then I sure didn't want to do it.

So I actually try to look at the big picture which includes AHI but is not limited to AHI along with subjective feelings as well.

The prettiest most perfect software report in the world doesn't mean much if we sleep like crap or feel like crap. It's a starting point only and for some people it is enough and for some it isn't and they have to dig deeper.

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Re: Assessment of treatment efficacy

Postby Jay Aitchsee on Wed Nov 08, 2017 3:08 pm

Doc, I think you've assessed the situation pretty well.
Most of us here that have been XPAP users for some time would probably want to see AHI in the sub 2.0 range. Generally, I think most of us feel better when that is the case. However, as you have surmised, the goal is to reduce apneas and hypopneas to a reasonable level (generally considered to be less than 5) and feel better. - to begin experiencing restful restorative sleep. If that happens at 4, or 3 or whatever, then fine. Generally, we would want to accomplish this at the lowest pressure possible because higher pressures tend to make the therapy less comfortable and more problematic with the possibility of leaks, swallowed air, etc. Some, usually newbies, strive for the lowest AHI possible (0), Personally, I think that is likely to be counter productive and is not apt to produce better quality sleep.
You do need to assess what type of events you are having. Centrals will not respond to an increase in pressure and, in fact, may increase with increased pressure.
So, in short, to treat the apnea and feel better is the goal. A zero AHI should not be. What many fail to realize causing them to continue to press for a lower AHI is that CPAP can only fix respiratory problems. It can not fix poor sleep due to other things, such as depression, caffeine, meds, poor sleep hygiene, etc., etc.

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Re: Assessment of treatment efficacy

Postby FrederickRose on Thu Nov 09, 2017 8:39 am

Jay Aitchsee wrote:Most of us here that have been XPAP users for some time would probably want to see AHI in the sub 2.0 range. Generally, I think most of us feel better when that is the case.


This is interesting and good information, and it's the type of information that studies have a hard time demonstrating. For example, most thyroid doctors would agree that a patient who has an underactive thyroid and persistent symptoms consistent with that diagnosis despite taking enough oral thyroid hormone to put their levels in the "normal range" may benefit from taking a little more hormone to put their levels into the higher normal range (correlating with a lower TSH value).

However, despite the fact that we have been doing these thyroid studies for decades, the evidence to support aiming for a "more normal part" of the normal range remains very limited, and the practice of doing so remains somewhat controversial.

Coming back to my case specifically, it seems like a pressure ~10 keeps my AHI below 5, but I need a lot more to get it under 2. I'm gonna try to get there to see if I indeed feel better!

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Re: Assessment of treatment efficacy

Postby FrederickRose on Thu Nov 09, 2017 10:13 am

xxyzx wrote:the doctors love tsh which is meaningless
that only means the thyroid is told to produce T4
the body has to convert T4 to T3 to be useful

so T3 is the meaningful metric yet doctors go two steps back and rely on TSH

I have my doctor measure T3 and T4 to make sure they are good
he measures TSH because that is what docs do
but we know that my T3 levels are fine not just that the thyroid is being stimulated with TSH

I take T4 but some people have to take T3 because their body is not converting T4 to T3

if I had relied on TSH I would still be a zombie with no energy at all



I have spent my entire adult life studying the thyroid and can say with 100% certainty that the "truth" is somewhere in between what you believe and what you've depicted as the belief of your doctor.

For a relatively comprehensive, heavily referenced discussion, see this article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4267409/

Here is very basic explanation of why T3 levels are usually far less important than TSH levels in the diagnosis and management of hypothyroidism:

1) In order for T3 to have an effect in the body, it must be free (not protein bound). The vast majority of T3 in the blood is protein bound and our ability to accurately measure the tiny free portion is limited.

2) Even if you know how much free T3 a person has in their blood, how much effect that level of T3 will have in various tissues (such as the heart or brain) depends on A) efficiency of hormone transport into a tissue; B) efficiency of deiodinases in a tissue; C) availability of thyroid hormone receptor in cells; D) availability of thyroid hormone receptor cofactors in cells; E) stability of messenger RNA of thyroid responsive genes; F) efficiency of RNA translation to protein; etc etc (much more complicated than described).

In practice what this means is that a person can have twice as much free T3 in their blood as another person and yet their body can be half as responsive to T3 in any given tissue, thus ending up with the same amount of T3 action/effect in that tissue. In contrast, TSH levels vary greatly with changes in thyroid hormone effect rather than amount, which gets around all the aforementioned inefficiencies. Yet the TSH as an indicator of thyroid function is limited, because it relies on assumptions of A) normal hypothalamus and pituitary function; and B) tissue effect of thyroid hormone in the brain and pituitary being representative of tissue effects in other tissues. This latter may be important in some people depending on their deiodinase activity in various tissues.

3) For a hypothyroid individual on treatment, T4 and T3 levels (free and total) can vary greatly depending on the time of the blood draw relative to the time of medication administration.

There is much more to it than that, but it is a start as to explaining why to suggest that the TSH is useless and T3 most important is grossly inaccurate.

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Re: Assessment of treatment efficacy

Postby FrederickRose on Thu Nov 09, 2017 12:50 pm

xxyzx wrote:IF I ever say anything incorrect somebody will post true facts to prove it


Done. :)

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Re: Assessment of treatment efficacy

Postby nanwilson on Thu Nov 09, 2017 1:11 pm

FrederickRose wrote:
xxyzx wrote:IF I ever say anything incorrect somebody will post true facts to prove it


Done. :)



Doc. xxxyxz's claims have been refuted before... MANY times, yet he still refuses to accept that he is wrong or spouting wrongful information :? . He is never wrong... in his estimation only. :shock: :shock: .
Thank you for your insightful explanation , as I am one of those that has to take thyroid meds daily.
Cheers
Nan

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Re: Assessment of treatment efficacy

Postby Bertha deBlues on Thu Nov 09, 2017 1:19 pm

nanwilson wrote:
FrederickRose wrote:
xxyzx wrote:IF I ever say anything incorrect somebody will post true facts to prove it


Done. :)



Doc. xxxyxz's claims have been refuted before... MANY times, yet he still refuses to accept that he is wrong or spouting wrongful information :? . He is never wrong... in his estimation only. :shock: :shock: .
Thank you for your insightful explanation , as I am one of those that has to take thyroid meds daily.
Cheers
Nan


Thanks, Doctor, from another patient being treated for hypothyroidism. I appreciate the information you have shared. Best of luck to you in fine-tuning your own sleep apnea treatment. I'm still on the journey. :)
And in the end the love you take is equal to the love you make. - Paul McCartney

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Re: Assessment of treatment efficacy

Postby Bertha deBlues on Thu Nov 09, 2017 1:48 pm

xxyzx wrote:
FrederickRose wrote:
xxyzx wrote:IF I ever say anything incorrect somebody will post true facts to prove it


Done. :)

============

Thank you

Keep in mind that a lot of facts people post are also just opinion and many times misinformation


Ah, but FrederickRose cited the sources, and even gave links.
And in the end the love you take is equal to the love you make. - Paul McCartney

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Re: Assessment of treatment efficacy

Postby Jay Aitchsee on Thu Nov 09, 2017 2:21 pm

FrederickRose wrote:
Jay Aitchsee wrote:Most of us here that have been XPAP users for some time would probably want to see AHI in the sub 2.0 range. Generally, I think most of us feel better when that is the case.


This is interesting and good information, and it's the type of information that studies have a hard time demonstrating. For example, most thyroid doctors would agree that a patient who has an underactive thyroid and persistent symptoms consistent with that diagnosis despite taking enough oral thyroid hormone to put their levels in the "normal range" may benefit from taking a little more hormone to put their levels into the higher normal range (correlating with a lower TSH value).

However, despite the fact that we have been doing these thyroid studies for decades, the evidence to support aiming for a "more normal part" of the normal range remains very limited, and the practice of doing so remains somewhat controversial.

Coming back to my case specifically, it seems like a pressure ~10 keeps my AHI below 5, but I need a lot more to get it under 2. I'm gonna try to get there to see if I indeed feel better!


A couple of points:
As I alluded to before, one shouldn't expect cpap to fix things it was not designed to do. Not that your are, but many do. Poor sleep can be caused by many things, only one of which is SDB. Once SDB has been corrected, if poor sleep and fatigue remain, one must look elsewhere for the cause. Fortunately, it is fairly easy to fix most SDB with XPAP. Unfortunately, other causes of poor sleep and fatigue are often very difficult to discover and correct.
Additionally, one shouldn't expect dramatic results from CPAP therapy immediately. For most of us, I think, truly restorative sleep took some time (and some work on things like sleep hygiene). Here, I am saying don't be in a rush to get under 2. It takes time for one's body and mind to adjust to the therapy (sleeping with an alien on the face). Most of us would recommend small changes gradually. If you change the pressure, for example, let it ride for a while. A week would be good to determine the result. You might find that your current AHI will fall on its own without additional changes as you become used to the therapy. This is especially true if a significant portion of your AHI is made up of CA. CA's will often resolve on their own as one becomes accustomed to the treatment.

Edit: In terms of efficacy as treatment progresses, in addition to "feeling better", some experience a reduction in blood pressure and an improvement in nocturia.

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Re: Assessment of treatment efficacy

Postby poppi2 on Thu Nov 09, 2017 6:34 pm

Jay Aitchsee wrote:..... and an improvement in nocturia.

Enough reason for me to stay on cpap.

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Re: Assessment of treatment efficacy

Postby FrederickRose on Fri Nov 10, 2017 12:27 pm

nanwilson wrote:Doc. xxxyxz's claims have been refuted before... MANY times, yet he still refuses to accept that he is wrong or spouting wrongful information :? . He is never wrong... in his estimation only. :shock: :shock: .
Thank you for your insightful explanation , as I am one of those that has to take thyroid meds daily.
Cheers
Nan


Bertha deBlues wrote:
Thanks, Doctor, from another patient being treated for hypothyroidism. I appreciate the information you have shared. Best of luck to you in fine-tuning your own sleep apnea treatment. I'm still on the journey. :)


Thanks, Bertha and Nan. I'm glad it was useful information. I've been meaning to make a YouTube video to explain it better, because what xxyzx expressed is a very common misunderstanding about thyroid conditions.

xxyzx wrote:and those were the party line old school traditional whizdumb beliefs
many newer doctors do not agree
and many patients prove the newer doctors are right
whilst many patients suffer because the old doctors wont accept that they are sick and look at the real problem because TSH said there is none

so it is as much opinion as fact
... that has nothign to do with TSH not being meaningful for many people
nor T4 not treating many people


This is not about new vs old doctors. Many doctors of all ages don't listen enough to how patients are feeling, are overly dogmatic about TSH, and don't understand that there are aspects of thyroid replacement which remain incompletely understood. This deficiency on the part of many doctors has led to the type of misconceptions which you have expressed.

I agree with you that some people with a normal TSH benefit from treatment and that some people may benefit from treatment other than T4. Many doctors, both old and young would agree with that. In fact, the heavily referenced guidelines I linked to explain how and why that is. But for you to go the further step and tell people that TSH is not a very useful test in general, or that T3 is a better test than TSH for most people, the old saw applies: "A little knowledge is a dangerous thing".

Jay Aitchsee wrote:Here, I am saying don't be in a rush to get under 2. It takes time for one's body and mind to adjust to the therapy (sleeping with an alien on the face). Most of us would recommend small changes gradually. If you change the pressure, for example, let it ride for a while. A week would be good to determine the result. You might find that your current AHI will fall on its own without additional changes as you become used to the therapy. This is especially true if a significant portion of your AHI is made up of CA. CA's will often resolve on their own as one becomes accustomed to the treatment.


Thanks, this is great information!

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Re: Assessment of treatment efficacy

Postby Guest on Sat Nov 11, 2017 9:47 am

xxyzx, why don't you put your money where your mouth is and post your data to refute Frederick???? Bet you can't!!

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Re: Assessment of treatment efficacy

Postby HoseCrusher on Sat Nov 11, 2017 10:35 pm

Frederick, The body is complex and trying to optimize a treatment is difficult.

Let's back up a little and look at a car. Some complexity and a bunch of computers trying to keep everything in balance. If I am traveling down the highway in my car and notice my fuel gauge is at half and also observe that I have traveled around 250 miles, I know my car is performing well. On the other hand if I am in stop and go city traffic I may only be able to go around 150 miles on a half a tank. In both cases my car is working well.

Same car, just two different conditions.

This indicates that we need to add context to our observations in order to understand the data points presented. I believe this also applies to sleep data.

Let's take a moment and step outside the box. I am going to try to compare "apples and oranges..."

Sleep disordered breathing has been shown to be damaging to the body. A sleep study looks at a variety of parameters and then the study is graded to determine if there is a problem.

Breathing while you are awake is very disordered but we seem to be able to compensate for that. It is still interesting to see the various patterns that show up while be breathe when awake.

If you want to look at this try putting on some soothing music and pick up a good book to read. Sit down in a comfortable seat, put your mask on and turn the xPAP machine on and spend an hour or so reading. Download your data and see what it looks like.

The next step is to put in a movie that totally grips you. It doesn't matter if it is sci-fi, scary, adventure, or home movies of the family. The idea is to draw you in and have you get totally consumed in the film. Mask up and record your data, then download it and see what that looks like.

Prior to reviewing your data, ask yourself how you feel and are you basically rested.

Your xPAP machine records data associated with air flow. Pattern recognition parameters are used to flag events but keep in mind that everything is based upon air flow.

My car has something like 23 computers monitoring a vast array of conditions in order to function well. My xPAP machine only monitors air flow.

By now you should realize that a lot of air related events occur while you are awake and somehow you survive. Granted sleep is different but there are a lot of things going on while you sleep and your machine is only monitoring air flow.

During a sleep study air flow is observed, along with heart activity, oxygen level in the blood, brain activity, sleep position, movement during sleep, effort to breathe, and probably a few more that I am missing.

To optimize your sleep I feel that all of these additional things need to be brought into balance along with air flow and then you will have a handle on the best pressure to use.

xPAP machines are not diagnostic. APAP machines have some learning capability and you can let them run in a range of pressures. This allows for some changes in sleep patterns and/or positions. Once again everything is based upon air flow. The machine is trying to find a pressure that will keep the airway open.

To optimize the therapy I think you need to review more channels of data. If you have an air event but it has no effect on blood oxygen or heart rate, how significant is that air event... If you have an air event and there is no change in position, how significant is that... If you have an air event and there is nothing going on with brain activity, how significant is that...

The solution is simple... but not practical. Spend two weeks sleeping everynight in the sleep lab. Review the data from everything every night and correlate it with your general feeling of health.

A more practical solution is to download the air flow data and try to make sense of it. In addition you can add a pulse oximeter to add a couple of additional channels of information.
At this point you will need to attach significance to the various channels of data. If blood oxygen levels are the most important, you really don't care about AHI unless there is a direct correlation with a drop in oxygen levels. and so on...

If a little pressure drops AHI to a "respectful" level, is it worthwhile to add more pressure to drive AHI to zero? The reduction from 100 down to 5 may be significant, but the reduction from 5 to zero may not be noticeable.

This brings us to your original question. How do we measure effectiveness? In many cases all we have is air flow data. Also in many cases that data provides enough information that some intelligent adjustments can be made from it. At this point we can say that the treatment is "good enough." Optimizing treatment requires applying some of the "art" involved with treatments or adding additional channels of data, or both.

This is what I did.

I noticed heart rhythm differences in my body. During a visit with my cardiologist he asked me if I snored. My wife jumped in and said YES, VERY LOUDLY. Also, he stops breathing. This set me up for a sleep study. Prior to the sleep study I purchased a pulse oximeter and began logging data during sleep. I had some desaturations but nothing really to write home about. I did see wild fluctuations in heart rate.

The study revealed that I had some desaturations but my brain activity showed frequent arrousals. This kicked in a rapid heart rate. The xPAP machine would keep my airway open and hopefully prevent the arousal from spiking my heart rate.

Lacking any other symptoms I started on xPAP. Years later I know my settings are optimized for me. My wife states that I no longer snore and she has not once noticed me stop breathing. I did develop atrial fibrillation but I now have that under control without medication but with the use of my xPAP machine and some diet changes.

Evidence based information got me started on my journey. In the end I applied some "art" and used that to dial things in. My goal is to live life to its fullest. My AHI score may be different from others but as long as my goal is being met I don't worry about it.

In the end if you leap out of bed fully rested and ready to greet the day, your therapy is optimized. :)

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