Is MY CPAP Helping Me?

Sponsor Messages and Show Introduction 0:00

Now a word from our sponsor, MedBridge Healthcare. Medbridge Healthcare is a leading provider of sleep lab management services and home sleep apnea testing. MedBridge partners with hospitals, healthcare systems, and medical academic institutions to offer comprehensive, fully integrated services for sleep disorders. Sleep Tech Talk is brought to you by Fisher & Paykel. Fisher and Paykel Healthcare is a leader in CPAP mass design and innovation for over 20 years. Their unique technologies have benefited millions of OSA patients through their top CPAP masks.

These advancements continue to further enhance patient experience and outcomes. Lights out. Welcome everyone once again to another episode of Sleep Tech Talk, the sleep podcast with your hosts and friends, Emerson Kerr, Robert Miller, and me, Dr. Gerald George Moneycroft. Folks, another episodes and it's gonna be a good one. But before we get started, just wanna say once, again, thank you so much for all the support that you've given us all these years and all of these episodes. Without you, we couldn't have done this.

A huge shout out to our sponsors who allow this to continue to happen. And be sure to check out the sponsors, all of you out there, and please continue to like, share and subscribe. And don't forget, we do have a comment section. Be sure and add your comments as well. With that, I'm gonna toss it off to Robert. Tell us what's going on today. Sleep Tech Talk is sponsored by React Health. Within our LUNA PAP device line, each offering is FDA approved, encompassing CPAP, APAP by-level and by level ST models.

Introducing Dr. Doug Kirsch and PLATO 1:51

Our thoughtfully selected array of PAPP interfaces and accessories complement our Luna Papp device-line while accommodating diverse patient requirements. Hey, Jerry, we have with us today, Dr. Doug Kirsch, who is with Atrium Health based out of Charlotte, North Carolina. I was able to review his background a little bit in the pre-cows, but what he's really working on and what we'll talk about, I think a lot today is the groundbreaking patient-reported outcome tool designed to monitor treatment responses and track symptom progression in adults with obstructive sleep apnea.

So we're gonna talk questionnaire. This innovative screening tool instruments fills a critical gap in clinical practice, offering reliable, responsive insights that empower physicians, patients, and healthcare systems alike. Dr. Kirsch, thank you for joining us today. We appreciate you being with us on the program and we're excited to be the first group to talk to you about the Plato questionnaire Thank you, for having me, Robert. Appreciate the invitation from all of you. Absolutely. Do you mind sharing with our audience just a little bit about how you got into sleep medicine?

And before we talk about Plato, it's probably good to give them some context. You are a former past president of the American Academy of Sleep Medicine. Yeah. So I got in to sleep in medicine back in about 2003, 2004. I was in a neurology residency and was writing an article with one of my mentors and sleep came up as a sort of an interesting topic that I hadn't realized was as much part of neurology maybe as it could have been, went off to do my sleep fellowship at Michigan and stayed on as faculty for a few years there, then moved to Boston where I was at Harvard for about seven or eight years, and now down in Charlotte for the last 10 plus years running sleep medicine for atrium health.

Um, Plato, uh, as you mentioned, has been a, something that started way, way back, not too long after I got into sleep medicine. Cause as I said, um, to you earlier that not long. After I started in sleep, adherence to CPAP became a big piece of how CPAC was paid for. And it was clear that some people benefited from CPF even when they didn't use CPAP to the specifications that Medicare made for them, right? That the four hours, 70% of the time was a number pulled out of a hat based on one study.

It was not something that was truly scientifically demonstrated as the appropriate path adherence. And so the ASM has gotten multiple groups together over time to talk about, well, if you're gonna talk measuring something, that's not just adherents to treatment, What is it that you need to look at what you needed to get as somebody benefiting from it. And so that's where the very beginning of Plato began this is, as I said, 2009 2010 somewhere in that range.

Why PLATO Was Developed 4:46

This began and then when I was president of the Academy. I made a hard push based on some of the information we had on task force. There was a full taskforce evaluation of both screening tools and assessment tools, and there were found some, not surprisingly, a gap in the industry that there was not a single assessment tool that we could use to sort of evaluate patients over time. The ASM decided to invest a significant amount of money and a small amount time in developing an assessment tool, and that's what PLATO is.

So PLATO, or what is the Patient Reported Longitudinal Assessment Tool, that is what it stands for. That is a tool for OSA and we think it's going to become hopefully the standard of care in terms of measuring patient outcomes based on their own report. Are you a sleep tech looking for new opportunities? Well, MedBridge Healthcare is one of the largest employers of sleep technologists and they are growing. If you are a Sleep Technologist interested in a new position, potential paid relocation, or looking a career advancement, consider a Career with Medbridge Healthcare.

Now back to the show. Fisherman Pykel Solo is the world's first auto-fit CPAP mask. It simplifies setup with its revolutionary auto lock technology. Simply stretch to fit, touch to adjust. Go to fphcare.com forward slash solo. Dr. Kirsch, would you describe it as a questionnaire? And for our audience who does work with questionnaires, how does it differ from the very popular stop bang? All right, so we'll start with, this is an assessment tool, not a screening tool. So StopBang is a OSA screening for most people.

That's the way that it's being used. This isn't gonna compare to that. I'm not gonna say it couldn't be, but it was not designed and wasn't tested for that, at least in the ways that we designed it. It was really designed to assess treatment outcomes over time. The basic criteria that we set up when we looked for the tool, and this was me very specifically saying it needed to be short. So there are a lot of tools out there, but they're incredibly long. They're used in clinical practice in academic centers where people will sit and fill out paperwork.

You used to get like, you know, 40 pages of things to fill it out because everybody's getting research assessed. Well, it couldn't be used a busy clinic like that, right? So it needed to be short. So the classic tool that most people are using today is the F-worth, so the upward sleepiness scale, eight questions, And it is required for many patients for insurance purposes. But the problem with the up worth is it only measures sleepiness, which is great in patients who are sleepy and measuring that they're less sleepy when

How the Assessment Tool Works 7:50

you treat them. But there are a lot of patients who aren't sleepy who have sleep apnea. And so you miss out on all the other pieces of that. So there have been some tools that have developed over time. Terry Weaver did a really nice tool. But a a of the tools done are owned by an entity or thing. That becomes a problem when you're trying to standardize what everybody should use a thing. Because if 10 owns this one or somebody else Harvard owns, this when it becomes the problem and so that part of the reason the Academy.

designed the tool was to make it easily, hopefully easily accessible for everybody because that's how a tool gets used more widely, right? You know, theoretically, I think everybody's supposed to ask for approval to use the app worth two, but it became just sort of like everybody just kind of did it. That's not technically correct and not how tools should be used, But the idea of this tool is it should able to be widely used and replace something like the Epworth as a, hey, every time somebody comes to a practice after trying treatment, whatever that treatment is, not just CPAP.

Could be an oral appliance, could be a medication, it could an Inspire implant. Whatever it is you can use this tool to assess before treatment and then again, as treatment goes on, are you improving their symptom? Dr. Kirsch, what's the frequency you would anticipate that a patient would complete this assessment as they are being treated with CPAP? And I'm assuming at some point you'd want it to become, or even the American Academy of Sleep Medicine would want to it become part of the maybe qualifying criteria, ongoing qualifying criterion for a patients for CPAT therapy?

I mean, I think the idea would be whenever they are seen, you would run the tool and then the tools is 11 questions. So it's not much longer than the app or so it was not going to take an enormous amount of time for somebody to complete. There are a bunch of Likert questions, so they have to read it and they had to set it up, but we've tested it, and certainly less than four minutes to compete the two. And the ideal would You know, maybe in a future state and I can't speak for the Academy that's not, you know I'm not no longer the president and no long around the board.

But what I would say is, I think the hope becomes that this becomes something else to look at besides adherence to therapy to show that treatment makes a difference for people. because I think that that has been missing for a long time. We've become entirely reliant on is a patient doing 70% of the time more than four hours. That has become the sole sort of metric of is the patient successful on CPAP or not. And the reality is we've all seen patients where they use CPAT eight hours a day and they're not feeling anything.

Or they're using it two hours a day, but they are feeling so much better, right? Well, those both matter, that how somebody feels makes a difference and the upward isn't going to necessarily pick up on that. And the hope is that Plato will. That's the way it's designed is to be a little broader, to a be little bit more inclusive to try and make it so we can identify those patients who are benefiting from whatever treatment it is that they have and be able to then show to insurers or to other clinicians that what we do is in fact making a difference.

Doc, what I found interesting is that- Thank you, sorry. Sorry, Robert. Yeah. What I find interesting with what you said about no matter what the therapy, whether it's neuromodulation or oral appliance, and nobody's really looking at that right now to your point of that it has always been how many hours and percent of days a patient has been on PAP therapy.

Clinical Use and Real-World Applications 11:40

Would you mind talking a little bit more about measuring that effectiveness on no-matter-what-the-therapy is? Well, I mean, I think that there are certainly tools out there that are being used. People have kind of gravitated to a set of tools. So for instance, I know that in some trials, there're tools that have been developed, the promise scales that had been used to sort of show fatigue. There's promise fatigue and there's a promise sleep disturbance, but they're slightly individually shorter, lumped larger, and they are specific to symptom, which is not ideal, right?

Because now you're talking about having to do three or four tools to get this to where you want to see the broader thing. And so this, Plato will look at three distinct areas. It looks at daytime symptoms, it looks nighttime symptoms and then it look the sleep quality. kind of conglomerates into a score. It's not the prettiest scoring system. I was hoping for something a little bit easier. But again, the tool was made through an enormous amount of research, help of an outside questionnaire building team from a company called ICON, and then a bunch of sleep experts from the Academy who all kind work together to form this tool.

And there's a negotiation that goes on about which questions are the best. both psychometrically, but also what's most useful for clinicians, right? And there's that balancing act of, well, that question's not quite as good, But it's probably more broadening for the questionnaire. And so that's where we negotiate. In the end, you got to 11 questions. I was hoping for less than 10. All right, 11 is good enough, it short enough. It's easy enough to use. Again, because it is not determined based on, Hey, are you doing well on PAP?

It's not asking that question. It is asking, hey, how is your sleep? Are you feeling tired? Are feeling fatigued? These kinds of questions, how are you snoring and how bad is it? That type of question is not specific to neuromodulation. It's not specifically to CPAP. You are being treated for a problem, and this is the breadth of the symptoms that we can assess in this tool. So that occurs, one of the things I'm thinking of is just the application of this. Physicians using this, they see some of information that the patients provided.

What have you noticed since implementing the tool that gave you insight that maybe you didn't have before? Maybe you could elaborate on something like that, some real world application Well, I can't elaborate on that yet because the tool has not actually been formally published. It will be published in JCSM in the very near future. Um, it is in print ahead of that publication. So people have access to it and can download it. The Academy has begun, uh, to release the, um, as well. But I couldn't, in fact, put it into practice until it was formally ready, and there is a process to make sure that it is ready.

So I can't give you any real-world data as of this moment, but I suspect give me a few months and you can always have me back and we can talk about what the real world looks like. But in the end, our hope is, myself and all the authors who contributed to this, that what you will really see is that that patients can improve symptoms regardless of treatment, and that this may not correlate 100% with how much somebody uses CPAP. It should correlate to some extent with that, right? You would expect that the more somebody using CPAT, the better a tool looking at OASA symptoms would improve.

But it doesn't mean it's going to be a straight line all the time, that again, there is some improvement that you're going see in patients who are Maybe using it less than you think is optimal, but that for them, this is really, you know, a huge benefit that their headache has gone away, that they're snoring is better, their sleep quality seems better. Whatever that thing is, and you can measure that a little bit. So just to maybe add on that question, if you can answer this one, that's okay too.

But, you know, the three of us spent time at Respironics. And one of the tools I think you mentioned, Dr. Weaver, is the functional outcomes of sleep questionnaire. Of course, incredibly long, I would think it was about 30 questions, but, it did give insights and there was a score that came with it. You know we saw some people loved it, some didn't even know it there the whole time they were using that technology. How do you envision, maybe is a better way to put this, the application of that relative to the different CPAP technologies and the therapies Jerry mentioned earlier,

Access, Publication, and Closing Remarks 16:48

how do see those interacting from that standpoint? Well, I mean, think the FOSS-Q and Foss-10 were really good tools. And yet the problem was, as you say, The FOSQ is too long to be practically used in a, hey, I'm seeing a patient in every 15 minutes or every 20 minutes. It's just not practically doable to have somebody sit there and fill out a 30 question plus questionnaire, which is why I think in part they developed the FOST-10. And the Boss 10 was faster, but again, to get the ability to use that questionnaire was part of the problem.

It was not freely accessible and was controlled by Terry and Penn, which was perfectly reasonable. They had spent the time and energy to develop the tool. But it can't become a standard if it's so hard to access to that you have to ask A single person or a single entity, ideally, to get to use the tool and and this is where I'm hoping and again I don't control the tools at this point it is controlled by the Academy, they are the owners of the tour and have the copyright of tool, but the, the hope is that this tool becomes.

as easily accessible as it can be while still controlling the copyright of it. And that's the tricky part right is that you can't just throw something in the wild because people will then use it when they probably shouldn't they can amend the tool without your rights, and so you have to have the ability to control that aspect of In order to make the tool really valuable, it needs to be in large EMRs. It needs be available to use by any clinician who's using it. As it comes to companies, that's a slightly different thing.

As you mentioned, you all work for Respironics. When somebody looks at using a tool in a trial, often you need to get access to that tool. And because you're doing a trail for your benefit, there is usually a cost to use a tools. So that is probably what will happen for that aspect of things. But I know that multiple companies have already started to approach the academy about the ability to access the tools, And again, the tool is literally just being released through MAPI in the last several days.

The Academy just sent out an email. I think it was Saturday. So you guys are very on top of the apropos of... the cutting edge, shall we say, today. We are. We try to stay up to date on the latest and greatest things and love this contribution to outcomes and patient care. I see this, and I'm glad that you already mentioned some companies are looking at this. If this were built into AirView or React Connect or Even thinking about ApnoMed and the fact that they are looking at wearables and outcomes tracking of their patients on a pharmaceutical, this certainly allows you to apply the same assessment to patients no matter what the therapy is.

I love that approach. Well, I think you have to understand that when you treat a patient, there are two things that matter. Probably more than that, but I will say just broadly, it's what is the data show, right? That's that's, what we use today is primarily the outcome. Is there apnea better and are they using the treatment? But the other piece is how do they feel? And what does that outcome and and what motivates people to get treated is often Hey, do I feel better? Am I making somebody else's life better, AKA my bed partner?

And is my health improving in the long run? Well, you can debate health improvement in long-run, and you know, sort of say, it's harder to test when you see a patient in front of you whether their bedpartner is better. But at least this tool gives you the opportunity to better assess, hey, Do I Feel Better? And in the end, we haven't asked that question well enough in sleep medicine. And maybe, just maybe we've built something that will do a better job of that today. Well, certainly have you on the program today to talk about the assessment tool.

But I just wanted to give you a second maybe to name some of the other colleagues that you worked with on this particular project, because I know that this was a long and dedicated group who had to bring this to fruition. Well, certainly I'm going to thank the ASM board director for continuing to support what was a very lengthy and not inexpensive project. But my co workers at the asm Shereen Thomas doctrine Thomas was an excellent advocate for the Academy and then the authors, the expert panel, which is Chip Davies, Charlene Gamaldo, and Freya Bossie Feinberg, Carol Rosen, who was an amazing writer.

She's obviously written a lot of manuscripts, but she really helped build this manuscript to where it needed to be and certainly deserved to the last author on this thing because it was a It was a bear of a manuscript to write and she did an awesome job. And then all the folks at ICON who helped do the science and psychometrics for this. Well, Doc, we are out of time. Thank you so much for a valuable bit of information and very, very interesting. Like you said, We hope to have you back in the future to hear the outcomes of measuring outcomes.

When, where could people get more information about you, Doc? So the tool will be published in JCSM and so you can find that on their website today. If you search PLATO, P-L-A-T-O and then the Academy, American Academy of Sleep Medicine will have information there. And if somebody needs to reach me, I am available at Atrium Health Sleep medicine. Awesome. Thank you so much, Doc. And all of you out there, thank you for joining us and all your support. Be sure to look at our sponsors, check them out.

Because without them, we can't make this happen. Until next time, lights on. Robert, if you could pause the recording, please. Be sure to check out our clinical sponsor, Sleep Review Magazine. More details in show notes.