Transcription:

Prakash Chandran (Host): Patients with sleep apnea traditionally have to go into a sleep center to get tested and monitored. But there's a new sleep system called ANNE that enables patients to get reliable sleep apnea testing from the comfort of their own home. We're going to talk about it with Dr. Charles Davies. He's a head of Carle's Sleep Center and sleep medicine specialist at the Carle Foundation Hospital.

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Host: This is Expert Insights with the Carle Foundation Hospital. My name is Prakash Chandran. So Dr. Davies, thank you so much for joining us today. I really appreciate your time. I wanted to get started by asking what exactly does ANNE stand for? And that is spelled A-N-N-E. And what is the purpose of the sensor?

Dr. Charles Davies: Yes. Thank you, Prakash. It stands for Advanced Neonatal Epidermal Sensor because it was first conceived with the idea that it could also be used for infants and neonates. And the purpose for the adult sleep population is to be able to diagnose obstructive sleep apnea at home.

Host: Okay. And this is actually a pretty big innovation because I know previously the gold standard was to always go into a sleep center, but given everything and all the restrictions around COVID, people obviously feel more comfortable if they can get those same results at home. Is that correct?

Dr. Charles Davies: Yes. So, certainly, we all hope that COVID will diminish in terms of danger to people. But we know also that it will be ongoing to some extent. And this does, as you indicate, decrease the chance for exposure of patients to COVID, because they can perform the study at home. And so, the purpose is to certainly have them be able to diagnose obstructive sleep apnea in the comfort of their own home.

Host: Yeah, that totally makes sense. So, you know, just being at home, I imagine that you can get a pretty accurate rating because the patient feels the most comfortable. And on top of that, I imagine that it also reduces the diagnostic cost. So rather than going into a sleep center, they have this device that they can just take home, they can wear it and then get accurate results. Is that more or less correct?

Dr. Charles Davies: That's correct, yes. So, this should be much less costly than the in-laboratory sleep study to diagnose obstructive sleep apnea. And we do certainly sometimes find that people have great difficulty sleeping in the unfamiliar sleep laboratory environment.

Host: Okay. Awesome. And can you talk a little bit more about how long ANNE has been around for?

Dr. Charles Davies: So, I first discussed this possibility with Professor John Rogers, who's now at Northwestern University, about a dozen years ago. And so, we've been continuing to work on developing and improving a sensor system for this purpose since then.

Host: So, let's talk a little bit about your findings. Can you share any results of patients or participants that have used the ANNE sensor successfully?

Dr. Charles Davies: Yes. So, we looked at comparing the ANNE sensor in a total of 225 participants, and these participants wore both the ANNE sensor and also the typical in-laboratory gold standard sensors, which that's how we normally do diagnose obstructive sleep apnea in the sleep laboratory. And so by comparing the two, we found that ANNE had 90% sensitivity in detecting obstructive sleep apnea and 98% specificity. Overall, there would have been 93% correlation with the gold standard in-laboratory sleep study results.

Host: Yeah, that's absolutely incredible. And I guess I should ask, can you explain to people what the sensor looks like and how it sits on the patient during the study?

Dr. Charles Davies: Absolutely. So basically, the system consists of two sensors one of which is worn on the finger, and that is detecting oxygen level, oxygen saturation. And it also does have the ability to be a motion detector as well. And the other sensor is worn essentially just above the sternum, so kind of in the middle of the upper chest. And that sensor is a motion detector and it's picking up both the respiratory motion of the upper chest. And also, it has the ability to pick up vibratory information and sounds coming from within the chest. So, for example, it can pick up heart sounds and breathing sounds and snoring.

Host: Okay. So, it can do quite a bit. And is it coupled with an app? Like how does it actually communicate and get the data to someone like yourself that is analyzing it?

Dr. Charles Davies: It's very nice and convenient for everybody because in contrast to both the in-laboratory sleep study equipment and even existing home study devices, the ANNE system is completely wireless. So, those two sensors I just mentioned, at those two locations, they're actually transmitting all the information via Bluetooth technology to a smartphone-type device and then that information can be downloaded for review by the sleep specialist.

Host: I see. And does the patient also have access to the nature of those results?

Dr. Charles Davies: Once the sleep specialist reviews that and essentially comes up with a final assessment as to what the data showed, then that report would be sent to the patient.

Host: That's incredible. Let's talk a little bit about the impact. I mean, we obviously talked about the convenience of having it at home, the fact that it's potentially a little bit more cost effective as well. Talk about how you think about the impact that ANNE has on sleep medicine.

Dr. Charles Davies: Absolutely. I think it will be a very large impact based on the FDA providing clearance for the ANNE sensors. We know that many millions of people can benefit. And I'll just break that down. So, these days it's thought that perhaps one in four adults has obstructive sleep apnea, most of whom are undiagnosed. Of that group, about one in four would be good candidates for ANNE. In other words, we have a high suspicion that they have obstructive sleep apnea and they don't have any disqualifying conditions, for example, things like congestive heart failure or severe COPD. And so, that amounts to about 15 million people in this country who would be eligible for ANNE and then would have the benefit of being able to be tested at home for a lower cost.

Host: Something I just want to get clarity on is you said I think provided it gets FDA clearance...

Dr. Charles Davies: Well, no, it does have FDA clearance.

Host: Oh, it does? Okay.

Dr. Charles Davies: Yes. So, that means that we can move forward and the next step is to basically scale up manufacturing of the device.

Host: Okay. Got it. So, it has FDA clearance. It's really about scaling up production and what are the steps that are being taken to do that right now?

Dr. Charles Davies: We're currently in the process of finding a manufacturing partner for this. And my hope is that by the end of the spring or early summer, we should have a manufacturing partner identified.

Host: Yeah, it definitely sounds like we're on the precipice of something big here that's going to help millions of people. Just as we start to close, is there anything else that you wanted to share about ANNE or sleep apnea in general?

Dr. Charles Davies: I would just emphasize that obstructive sleep apnea is a fairly common condition based on the numbers I just mentioned, and it's important to look for obstructive sleep apnea in your patients. And if you do have any history from the patient or physical exam findings that may raise the concerns for obstructive sleep apnea, by all means, refer the patient to the sleep clinic and we can proceed with the evaluation. And I think ANNE then allows for a convenient way to diagnose obstructive sleep apnea and and also have treatment started as soon as possible.

Host: And if people just want more information about the ANNE sleep system, is there a place they can go to learn more?

Dr. Charles Davies: At present, that would mainly be through the FDA if they wanted to learn more details about the clearance of this device. Until we have a manufacturing partner identified, there is not any further information that we can provide at this time. One other source though that I could add is if people are interested in the details of the study that resulted in FDA clearance of ANNE, they can certainly go to the Journal of Clinical Sleep Medicine and look up an article that I authored in the journal and it's been published in the Journal of Clinical Sleep Medicine as of last year.

Host: Well, Dr. Davies, this has been a fascinating conversation. I really appreciate your time.

Dr. Charles Davies: Thank you, Prakash.

Host: That was Dr. Charles Davies, Head of the Carle Sleep Center and Sleep Medicine specialist at the Carle Foundation Hospital. For more information and to get connected with one of our providers, you can visit carle.org. That is spelled C-A-R-L-E.org. For a listing of Carle providers and to view Carle-sponsored educational activities, you can head on over to our website at carleconnect.com. That wraps this episode of Expert Insights with the Carle Foundation Hospital. My name is Prakash Chandran. Stay well.