Well, welcome. I'm Dr. Susana Falar do Ramos, moderator for this evening's webinar on successfully applying for the Dental Research Award. I'm joined with our speakers, Dr. Nelly Yun, Dr. David Bender, Dr. Jeffrey Gustner, and Dr. Carlos Flores Mir. And finally, the EADSM does not endorse any service, products, devices, or appliance. The use, mention, or depiction of any service, product, device, or appliance during this webinar should not be interpreted as an endorsement, recommendation, or preference by the EADSM. Any opinions expressed or communicated regarding any product, device, or appliance during the webinar is solely the opinion of the individuals expressing or communicating that opinion and do not of the EADSM. Whenever possible, presentation should be supported by evidence. In instances where evidence is lacking, speakers have been asked to verbally disclose that their presentation is case-based or based on clinical experience so that you can use independent clinical judgment to make decisions for your practice and patients. And now I will turn over to Dr. Yun. So thank you. Thank you all for coming tonight. Our project was actually submitted for funding back in 2017-18. So it's a bit different than what is currently available through the EADSM because back then the EADSM was still part of AASM. So we went through the American Sleep Medicine Foundation, but still the points of my part are still relevant today. And so our project back then was to look at the trajectory of patients following obstructive sleep apnea diagnosis within a primary care setting. And we were looking at oral appliance therapy and we were looking at long-term up to 10 years following diagnosis. So I do not have any conflict of interest. And overall, in general, the study aimed of that was to look at treatment trajectory within a primary care setting, as I said, of CPAP most majorly and oral appliance therapy over 10 years, look at the difference in adherence of efficacy, look if we could distinguish users and non-users in terms of adherence and looking also if we added some information packets on oral appliance therapy, if that would modify their treatment trajectory over the 10 years follow-ups. So we're lucky enough to kind of piggyback on a study that was already funded and had been done in Canada. So the initial study, as I said, was the first three years following diagnosis. And then the ADSM study that we had submitted the grant for were follow-ups at eight and 10 years where we had questionnaires, a home sleep apnea test, some qualitative interviews where we asked patients about their disease management, their trajectories within the primary healthcare, and also obstacle to treatment. At the eight-year benchmark, we actually gave them these information packets on oral appliance therapy and to see if that influenced their disease management trajectory. So that basically was our study that was submitted for funding through the ADSM. Do you see the next slide, which is results? Yes? Okay, perfect. So overall, we initially had 230 patients, and you'll see we had quite a number of attrition or like loss to follow-up. And I'll kind of go back to this on the next slides. We only found 10 patients out of the 200 patients that actually had an oral appliance therapy through the primary healthcare system. And we did see that when we did give the packets on oral appliance therapy at eight years of follow-up that we didn't see any changes in their trajectory. Probably it was too little too late to have this information given to them at the initial diagnosis of OSA and the initial treatment plan would have probably had more impact than so late in their disease management trajectory. And so from the CPAP cohort, what we saw was from baseline, it went down from 65% to 19% of our adherent users. And what we found, the characteristics is so those who were adherent to treatment 10 years later were those with higher baseline sleepiness scores, a higher reduction in severity of their symptoms on insomnia, but overall it was mostly sleepiness more than insomnia or fatigue. That was a characteristic to identify those who are going to be adherent users to CPAP. So regarding our application back then, it had five forms to fill out, which is slightly different today, but overall we had like a title page, six pages of objectives and methodology, is short biosketch, like a CV of each of our team members, about two pages. A detailed budget was requested and three pages on human subject protection plans, which is ethics. And if I can share anything on my experience and on the tips I would recommend, I kind of, I go back to a tip that a mentor had given me when I was a student, was that 90% of research is done within the planification stage and 10% in the execution stage. So really make sure in the planning stage that you define your study objectives that are very well defined, that they are realistic according to the methodology that you're going to be using. If you can, is to have a pilot study where you could try out the different procedures and the methods and see if the answer and the adequate for your objectives, and to also try to minimize any potential pitfalls. A strong infrastructure, so qualified and trained teams, so they can be standardized between each other for data collection. If you can, have access to a mentor, so somebody who has experience in clinical research, who's already done these grants writing, that can review your grants, review your protocol, somebody that can bounce ideas off and can have a bit of input. If you don't have access to a mentor, I would say reach out to ADSM or to the discussion boards on the ADSM. There's quite a lot of people out there and I'm sure some people can reach out a helping hand. If you can have statistical supports, either a statistician or somebody who is pretty comfortable with statistics, for the planification of the protocol of the grants, calculating sample size, power of your study, making sure that the analytical plan has already been established before starting anything, that's really helpful. And also that infrastructure is set in place to recruit patients and participants for the study. And the last but not least is to have a realistic and adequate budget. Make sure you have enough resources and infrastructure to cover all the logistical challenges that may be encountered. For example, making sure that your dropouts and patient loss to follow-up are accounted for in the budget, because that happens. Some of the pitfalls that we've encountered, so this is the timeline we had submitted in our grants and you can see it's like two years, but some of the issues we found, we met, I would say. A lot of delays at the beginning, the contract signature between our hospital and the funding agency took about six months and then fund transfer with our finance department took another six months. So we had an ethics, so we might have had nine to 12 months of delay to start. And then obviously COVID hit and we had not planned for that. So that explains a lot of the dropouts and refusal to participate. We had to pivot about how to see patients, how to get them the HSATs to do sleep studies at home. And thankfully ADSM was very understanding and very supportive and they gave us an extension to do the study and to get the funding. So that's about all of my experience and I'll let the next person come up and share. Thank you, Dr. Yoon. And now we will hear from Dr. Bindem. Okay, can you hear me now? Yes. Okay. Thank you. And I just want to say that I'm still in clinical practice. I'm still doing dentistry and my sleep practice is about a third of what I do. I'm lucky enough to be affiliated with Mount Sinai. And at the time of my application, they weren't interested in doing any oral appliance therapy research. So I applied to the AADSM and was turned down the first time. And the second time I asked them for a little help and that was what I needed. For anybody who is doing this, I think the AADSM is a great resource and Heather was a great help. So my topic was comparing two titration methods to establish an effective titration protocol for the oral appliance therapy. So we can go to the next slide, please. I have no conflicts of interest. So I just want to tell you my experiences. And I'm going to mention what my project was in a little bit. And then throughout the slides, I have some ideas for anybody who wants to do some research. Okay. Next slide, please. So my experience is that you need help and you need to work with someone that knows what they're doing because this is a whole field unto itself. This is my first exposure to work with an institutional IRB. I mean, that's a whole another level of things you need to do. To work with Mount Sinai, we had to take hours of credentialing courses, these city courses. And we also needed to learn about budgeting. This was really demanding requirements. Working with a experienced PI, just to format how to write up a proposal is so important. So again, a mentor is, I found, very important. Once the team was interested in including me on, you know, some research projects, it was really great. I think it's very competitive because there's individuals who actually know how to do this. So getting your team together is important. In my dental practice or my dental sleep medicine practice, I have a dental sleep medicine coordinator, Kritika Patel, and without her, I could not do a research project. And she also helps me clinically. So there's a tremendous amount of work that's needed to, you know, maintain records of all the research. So, you know, if anybody's planning to do this is, you know, you need to know the time that's involved. Things happen. Patients are really interesting. They don't realize how important this is to us and to the field. So any incentive from toothbrushes to free cleanings. But I think that the thing I've learned because from this project, they saw that I could actually treat patients and work in an investigative team. We did another couple of projects, and the projects that there was no fee to the patient for an oral appliance was much easier. I found over time, and I also, this project went back to 2018, and it's really not done yet with COVID. And I was delayed almost six months just having to change the consent with my institutional IRB. Unknowns. Patients forget appointments. They drop out. They lose and damage equipment. They don't return the devices on time. They just hold on to them for weeks at a time. And you're calling them, I need the HST back. I need, whatever. They get dentistry done. And we're evaluating oral appliances and it doesn't fit. Do we have to make new ones? Okay. Next slide, please. Was this my next slide or telling about the project? There. There. So my study was to compare two appliance titration or advancement methods and establish an effective titration protocol. So I figured, you know, I bought the matrix, you know, by Zephyr. So that was an unattended auto titration method with a test appliance. And I thought I would base my clinical titration against the matrix. So it really was like binder versus the matrix. And I was blinded with the matrix results. COVID hit. Zephyr went out of business. So, you know, I really didn't know what to do. The AADSM was very gracious and helpful and let me pivot. And the Mount Sinai helped me figure out what to do as well. So I was trying to get, you know, 60 patients with their AHI 4 or above 5 and the RDI around 15 or above 15 and willing to use the oral appliance. And I figured this would take about 8 to 12 weeks per patient. But I had to pivot. So instead of using the matrix, we decided to use a multi-night watch pat one and comparing two pertusive settings at 55, 70, and one millimeter away from max with a permanent oral appliance. And I thought adherence was important. So we put in the Theramon compliance monitor. Next slide. So I'm almost there and I'm a little torn whether to continue or not on my own without the funding. The data, I'm still blinded to the data, but I think I'm going to stop because other research projects are beginning to start. So this whole process enabled me to actually get into research. So we had another research project based on this very model of my pivot, which was called the multimodal. So this was based very simply where a patient would choose their own treatment at first, but if it's not effective, we would switch therapies to something else. So we tested initial efficacy at different protrusive settings with a temporary device and we would see where it best was or if it was a failure immediately. So basically it was any method to get the patient treated. And then prosomnus came along and they wanted to do a severe study for the FDA. So I was doing that at the same time. So you really need a team. And then about to come down, start any time was an essential study. And this would be the effects of successful OSA treatment on memory and AD biomarkers on older adults. So this is very exciting because we're gonna get health outcome data from these studies. So my experience has been great. It got me started. And I have a lot of exciting other projects coming through. Thank you, Dr. Bender. Next, we will hear from Dr. Gerstner, please. Okay. I'm assuming you can see my slides. Great. Yes, I'm Jeff Gerstner. I'm at the University of Michigan. I've been funded for a little more than a year and I'm gonna talk about my experiences, the pluses and minuses and how I went about writing. I have a few conflicts here. Nothing that's really going to impact my presentation. I wanna talk about my experiences first with writing the proposal, the steps along the way. I hope along the way that some of the things you'll be able to connect to and they will help prove useful for you in proposal writing. And then I'll talk a little bit about my project. So if you've done grant writing before, this might seem obvious, but if you're gonna do a proposal, you really need to be in your area of expertise or you need to be working with collaborators who have that expertise. And so I have expertise that I've been teaching and doing research and service with in dental sleep medicine for many years. But that doesn't mean that I know all of dental sleep medicine. There are certain things that I have more expertise and more confidence in. And that's what I chose to focus on. So when you do this, usually there is a newsletter or on the AADSM site, request for proposals, and they'll have a number of them. And looking through them, you can identify a topic that hopefully is in your area of expertise, something you would be excited about doing. My particular interest was in doing evaluation of consumer sleep technology. And so that's the topic I chose. Once you've identified the topic, usually there is a letter of intent that's required first. Before I even get that, I have to do sort of initial self-talk and determine, do I have time to write it? And more importantly, if I get it, do I have time to do it? And I also look at the logistics and feasibility. So a part of the time and budget, there are obviously restrictions on the size of the budget. So very early in the process, I want to pretty well define what the aims are that I wanna do, what the hypotheses are, so that I can then focus either on pilot data that I've done before, or into the literature, look at data that is quite similar to what I've done and do a power analysis. What size samples do I need in order to be able to answer the question I'm interested in? And then multiply that. So then I have to think about how much time is it gonna take per subject? And what's the cost per subject multiplied by what the power analysis says, and then say, with a more objective perspective, will I have time and money to actually do the project? So if all of the above goes in, we go with a letter of intent, which I did. And then, that's just a couple of pages. It's relatively, I think the toughest thing with writing letters of intent is to make sure within the space you've been given to hit the most important topics. But there's also some other things to consider. These have been mentioned before, but if you're going to be doing a human study, the IRB approval and how long that takes. I did a Bitesplint study a few years ago. And for whatever reason, the IRB at the University of Michigan thought that a dentist was doing heart stents. And so it went to the full committee, which was 24 people, and it took a year and a half to get that approval, even though I argued that they had misunderstood the proposal. But anyway, the IRB can take a long time. So you need to consider when you're gonna start that. And then, obviously, budget calculations and time calculations, those all need to be, if they're not directly in the letter of intent, you should really have them so that you know whether you can do the project or not. So this is one of the pages out of my letter of intent. I chose the domain. I figured I would need to get more subjects than would be in existence in my personal dental faculty practice. So I got a couple of people to work with in and outside the university. And that made me feel much more confident. So they became part of the research team. For the letter of intent, it only required my bio sketch. And then, as I said, there's a one to two page synopsis that needs to be written. Months later, you get a letter back, either you've been approved to continue or not. And if you get the letter, then at that time, I need to rethink what's the status of my professional life going forward, do I really have time to do this? And in an earlier round, I think it was probably two or three years ago, I did a letter of intent. And when it came back, by the time it came back, we had lost faculty and people that I could, that I needed to work with. And because of those changes in my life, I had to say, sorry, I'm not gonna be able to write a full proposal. Okay, my writing process, this just works for me. I like to write outlines first, because writing full sentences can distract from the creative process. Also, as I start to write it into prose, I don't care about page limitations, because I wanna make sure that I can get everything out there without having to think about writing restrictions. Once I get it into a reasonably readable state, I like to have somebody else read it before I spend a lot of time doing a lot of reduction in how much space I'm taking up, just to make sure that I'm on the right track, that it's comprehensive, that it's a reasonable project. And if I get good feedback, then it's time to start editing. And also, I should mention that with a letter of intent, at least in my case, it came back saying you're approved to go ahead with a full proposal, but the committee has a couple of suggestions. So I need to think about how I'm going to address those suggestions in the grant. And I think it's important to know what you can do to reduce the length of projects. So using figures and tables, if you think that they're gonna help, wide margins, et cetera. And then as you go, the things you need to have are, can you see my arrow? Great, okay. Aims and hypotheses, methods and study design, outcomes and deliverables, discussion of significance, budget and project timeline and background. Those are all sections that were required in the grant. And this is a kind of a circular process because each of these things inform each other. And it's very difficult to write one and then move on to the other, because as soon as you get into methods and study design, it might change the nature of aims or hypotheses. So this is a kind of a circular project. It's kind of an internal circle. The two external things that I'm paying attention to are ADSM communications I might have, and then the literature. And for purposes of the ADSM grant, it's obviously important to know your audience. So you're talking to ADSM people. And so I chose to look at the study reading lists that are on the American Board of Dental Medicine page first because I recognize that's what everybody's looking at. That's what everybody's familiar with. And then go ahead with a full Medline review for the last couple of years. And this is just three pages of my proposal. So you can kind of see some of the things that I did. So up here is addressing the reviewer comments, using abbreviations so that the full text doesn't take up room. A lot of white space where it's possible. Very narrow margins because I needed them. Make sure you use the KISS principle in writing the specific aims, so keep it simple. And tables and figures that can help make more sense to people who aren't as familiar maybe with the methods or the results that I am wanting to achieve. So let's talk about, this is kind of my personal looking backwards. What did I do right and what did I do wrong? So in terms of positives, I did stick with my expertise. In terms of keeping it simple, one of the things I did is recognizing that the projects are relatively short in time and the budgets are quite limited. I wanted to make sure that all three aims could be addressed with a single night sleep study so that I wouldn't have to do a night per aim. Communicating with the university, at least for me is really important because there's, I don't know, five or six people in committees that I need to always have in the loop, otherwise it'll take long. I started the IRB early. I think that's a good thing to keep in mind, whoever you are. I did a pretty good job of estimating the timeline. I also have a really good research assistant that was, and that's kind of luck of the draw occasionally, especially at a dental school where you're relying on, often graduate students in various graduate programs. You need somebody who is really dedicated to the project to help out. I was careful to address the reviewer comments. I listened carefully to the voices of my science and writing mentors. Using a home sleep apnea test type two and a camera were good calls because those are the things that other people that are in the area consider to be high quality home sleep tests. And obviously this is gonna generate a lot of results. So there'll be a number of papers that can come out of this. The negative things were I did choose people who I thought would help, but their lives got busy. And so I haven't been able to use two of them. For one reason, two of them moved on and then a couple of them are in private practice. And it's an education to get them to understand how we do research. I could have communicated better with the ADSM on certain things. Where I failed with respect to keeping it simple was that I added another device that wasn't a part of the actual focus of the three aims, but I thought it was useful for additional things that I might get out of it down the road. COVID did a huge number on this. Part of the project relies on getting polysomnographic data. And I don't know how most of my colleagues in medicine that I work with are members of the University of Michigan. And most of them started to do home sleep tests as their follow-up studies. So I didn't have access to the polysomnograph. And so I had to communicate with the ADSM so that I could make changes with respect to that. These are the devices that I'm using. We're actually testing a phone app that looks at snoring and a ring that looks at pulse oximetry. This is our type two device cameras that we use that we have the patients put at bedside at home so that we can evaluate what's actually happening in the room. And then this is the thing that isn't really a part of the focus of the aims, but we have this also to look at masticatory activity. So what's the bruxing behavior? And we also have some electrodes on the throat to look at swallowing, coughing, and sleep talking. Not gonna go into any of this, but the idea here is that we've got these two commercial items. And we're gonna compare the results with a recent polysomnographic study that the patients have had, as well as to the home sleep testing device that they're wearing. And the pluses and minuses are these. Obviously the minus with the home sleep apnea test is that it's not the gold standard, but we're doing it at exactly the same time, the same night. So we're getting the same data from the testing devices we're looking at with respect to a home sleep apnea type two test. And then of course, the gold standard is the polysomnographic study, but it's done on a different night. So there are pluses and minuses with both of the comparisons we're making. And we've seen 25 patients. And I'm currently using what's known as Lynn's Concordance Correlation Coefficient, because what we're doing is we have four groups. We have controls, we have mild, moderate, and severe sleep apnea patients. And if you're gonna be doing sensitivity and specificity, accuracy, and validity, you can do that with only two groups. Lynn's Concordance Coefficient allows us to do a continuum from those without to those with severe. And it has built into the statistic a measure of accuracy and precision. So I was really happy to find this having talked to statistical colleagues. I think it's really neat because it can answer the questions we're interested in. And I think the biggest challenge in going forward is introducing the actual statistics since it is so arcane. And that's, I think that's pretty much, yeah, all I wanna say. Thanks very much. Thank you, Dr. Gerstner. Last, we will hear from Dr. Floresmir. Perfect, thank you. Thanks a lot again for the AABSM for allowing me to share some of our experiences. As always, the research projects are teamworks. And so in this case, actually, this project was Emily Kings that was a former MSc student, resident orthodontic resident, but also involved the physiology lab at the university. So Craig Steinbeck, my colleague, will be the co-PI. And then Sana Ayesha was a PhD student also using part of the data. So the idea was to assess the effect of mandibular advancing devices on sympathetic nerve activity and markers of cardiovascular health in OSA patients, right? And it's a feasibility trial because actually what was supposed to be an RCT turned to be a feasibility trial, and I will explain why. I do not have any potential conflict of interest to disclose. And so then the task today, and within 10 minutes, it's going to be quite challenging, but basically, you know, our experience is applying with the Dental Research Award. I will then move briefly into the study methodology, and we'll just share with you some of the initial findings. And I will wrap up with some take-home message, which actually will go back into tips about applying for the research. And so I think from the application comments, actually in this case, then point number one, so we did apply mid-April. We got a request for clarifications by late September, same year, but in the final offer, the support came in June. So it will save to some degree then, that may have been just my experience and not necessarily a common experience, but a year plus then to get the final result, it's kind of to some degree a delay in the process, but we're really happy to actually have had that. Now the positive is actually the application was really easy to be filled out, right? Not a monumental task, not difficult, and then actually I had to start with a progress report this December and I actually found it very easy too. So two positives there. Now the idea is basically to assess the impact of repeated nocturnal hypoxia, right? And to some degree we're going to focus on sympathetic nervous activity, or as I will call it, SNA as we move around. As long as you're not orthodontist, you're not going to be confused with the SNA. So the idea is that actually the impact of OSA in this case can be vascular and that with significant health consequences. Now a MAT device we all know, right? And so basically SNA, so what's the real impact there? With any research question you probably want to first explore what we know about the question in advance. So therefore we undertake a scoping review. Basically a scoping review, it's kind of like a systematic review, but the idea is not really to address a specific question, but a more broad question, right? And so we try to understand overall, right, in patients with OSA that have used some MAD appliances around what has been reported, what methods have been used, what conclusions were drawn. And then you see here from a potential of 233 articles, we really identify at the end of the day a text only, right? And when we look into this as a summary, doing this scoping review, we realize that although it's reported that microneurography, which is what we propose to use, it's a direct method, direct measurement. It was discussed in these papers. The indirect methods discussed were heart rate variability, HRV, blood and organorepinephrine concentrations, blood pressure variability, and baroceptor sensitivity. But at the end of the day, all the eight papers we identify use HRV as the primary measure. So none had used microneurography. You will understand why in a moment. And so then two were randomized controlled trials, four were non-randomized trials, two retrospective studies, and then two pilot studies. So really eight papers around this area. But then at the end of the day, these all papers concluded that three months of mandibular advanced device therapy resulted in significant change in HRV indexes. So the indirect measurement actually gives very positive changes, indicating positive cardiac autonomic modulation. Now, the drawback of HRV is actually does not isolate SNA well. So that will be the reason why we're conducting this randomized controlled trial to turn to be a feasibility trial at the end of the day. So our primary goal was what is the effect after three and six months of a fully titrated MID therapy and SNA in a population mild to severe. Now, our main outcome will be microneurography assessment. And secondarily, we're going to look into endothelial health. So now, prospective self-controlled case series. So basically, in other words, we are not looking into a lack of treatment because like consecutive patients that accept to participate in study and try to assess their SNA result. As we don't have at the University of Alberta a strong dental sleep medicine clinic, then we have to actually try to get the cases from multiple sources in the community. And that's going to be a drawback, as I will report later. They always say it had to be done by a physician, not implied by a dentist or by using at home devices. The actual prescription of the MID, like the design of appliance, is not for us, the research team, to decide which ones actually accept any MID, that is going to be also a limitation for the study. All other patients and with not obese patients. And then to some degree, we were looking for extreme cases and try to then exclude patients that have some characteristics that we know are going to affect the end results. So now, this is probably, at the end of the day, based on the scoping review, doing the microneurography would probably make sense. But the problem really comes into how complicated it is to actually measure it and then how provider-dependent it is, right? Because then we have to use the physiological lab at the university. It's not something that you can easily do in a dental office or in our case, in our dental clinic, per se. And so basically, the idea is to directly use and measure the sympathetic activity indirectly there and not indirectly, right? And if it is properly used, then it's highly reprocessible. But then again, to try to get the measurement consistent is not necessarily as simple as it sounds based on this summary. And we're going to look for a percentage change in these cases, right? And so now, we did produce a referral flyer for dentists that actually provide MADs. But then these are some of the drawbacks that we realized as much as you plan around, right? So basically, people that were approached did not want to drive to our lab across the city, so actually come to the university. Then patients, in general terms, do not necessarily look forward to an additional appointment because this was not done well they were in a dental office, but they come to us, right? And then as everybody today has discussed, COVID did not help at all, right? Because then it would make it very difficult for the patients to actually come and to some degree, the financial burden on their community and being able to afford MAD treatment because that's not covered by the government in Canada, right? And then also, then the dentists are not necessarily, although they sound like, yes, let's talk about this. The moment you actually talk about the project and what was implied, then a busy practices, they're teaching, they're traveling, right? Then they already have lost staff during the COVID-19. So to allocate the staff to actually provide the explanation of the study, even though we offer to come there, right? And then, for example, we have one of the main appliances actually come out of the market while we were doing the research project. We have to adapt and so then we have to ride back into our ERV to try to get authorization to do some things differently, right? And so we explore maybe the companies where we're willing to donate the devices and we quickly decide not to do it because then they were going to be perceived as a conflict of interest if we were to finish the trial. We did finally support and we got that authorized to actually give the patients $200 to participate. And the idea was there basically for the time it takes for them to come to the lab and then the breakfast and be there and the hours it takes to get the information. We tried to go international but it was not clearly easy because, again, the physiology lab that we have is not something that you can consistently have across different cities, right? And we keep contacting dentists to get them to go through the process. So the current results kind of going close to the end of the presentation. So we actually got 10 referral bases in the city contacted, 7 responded, 5 agreed to refer to study. But in reality, only 10 patients were referred to us. Our goal was initially 50 and so we are well short of that. But then even from then, these 10 patients at the end of the day, we see how the numbers keep coming down, right? Two did not return calls. One were ineligible because they had actually used NLA before. They actually were approached. Two actually started with using the device before we could actually do the baseline test. And actually one had a mixed apnea diagnosis. So we have a final sample so far. We keep collecting patients. Four patients, three females, one male, all coming from the same provider. And then the device uses the Pantera brand. You see in the right a little bit of the characteristics of these patients. We don't really have a lot of time to go in detail with this. But interesting enough, three participants lived seven hours outside of Edmonton. So if you come from the dental appointment and then try to come to our physiology lab, you see then some of the data we collected for the patients regarding to medical history, type of medication. Anyway, this is an example about where they're coming, retired, volunteer. And to give us an idea, this is voice pilot, give an idea, you know, takes around, in this case, four patients, 100 days to actually complete device titration and reach efficacy. But then in between appointments, we have 150 days, which is almost half a year in between. We can take the information from time one and two. So the testing, right? So even if they come and now we're going to the physiology lab and there's people who are trained for doing this. Well, equipment did not work in three of the sessions, right? And we give explanations there, right? And then COVID and then the blood sampling and collection. So some of them, and so we keep getting the four and then limitation the four. Participants will live far away. We had them, three, giving them the sleep devices at home just to monitor, not to find a diagnosis. And then some were not going back. We offer device pickups, but it all declined. So you see, it's doing clinical research is not really easy at all. And so anyway, so at the end of the day, based on the data and that's data being defended as part of the thesis, but we continue with the project is, you know, if you actually have the patients actually come, then actually microneurography it's useful and can be used during the intervention, right? The challenges in summary are a small pool of potential participants. COVID-19 affect everybody. Depending on only one provider, it's kind of good and bad. Good because we are only dealing with one specific type of MAD device, but then you depend on one provider. Then the actual measurement of the signal is tricky and the participant factors, right? And so communication, various kind of multicultural community, and then people don't necessarily understand. So wrapping up, once we are able to report this feasibility trial results, it will be theoretically the first one to use microneurography in an MAD intervention. We believe that the collection of our preliminary data, and we again, thanks TSM for supporting us, will inform future similar studies. And so then some of these problems that we're going to be reporting will help other research teams to actually then avoid them or plan them in ahead of the game, as we have discussed from the other presenters. It's important then to build these connections within the dental community, interact with them. It takes a lot of time to get them to participate, but there are limitations, right? So time in between measurements is completely unpredictable, right? You get communication, you can bring the patients back, they're busy this week, the next week, when they can actually come. Understand the lifestyle changes, stress that could actually affect the measurements. It's probably unfeasible, very difficult to plan this, to be randomized or control in the future. What will be your control? No treatment, not a good idea for OSA. And then the definition among different providers, right? So we have to trust them that when they call the patient having a mild or moderate, we will not going to argue about that. It's just their decision, we simply are going to measure in between appointments, right? If we were to be able to reduce the travel time, number of appointments, chances are we're going to get more patients. We need to further improve communication with the providers, so we get more referrals. And then try to reduce the laboratory length visits, but that's not necessarily as easy as it sounds. Thank you a lot for your time, happy to entertain questions. But Nelly, go ahead, I think you can make a comment. I would say to those who are listening in to go for it. There's not a lot of funding for dental research. We're always in competition with medicine, medical research. And so ADSM is giving us an amazing opportunity. They're very supportive, very open to research and your proposals. And as Dr. Binder was saying that you can apply once and get refused, but you get a lot of really good comments. It's a great way to test the waters and to get a lot of good feedback from our scientific committee. And you can come again, and there's no limit to how many times you could submit a grant. I think Carlos knows we get more refusals than we get yeses. So I would recommend go for it and get the feedback, improve your protocol, your grants, do a few patients, test out the waters, talk to a lot of people during the conferences, and you can grow your team or get mentors or new collaborators. But my advice would be jump in, go for it. And I think I agree, Nelly. I think you're free actually. You should invest a lot of time planning ahead of the game. But then in my case, I got overexcited with planning this. And then when you actually try to execute reality, so maybe another way to look into this is it's okay to actually just plan something small. Just propose it to five, 10 patients, right? And I'm sure the SDM is going to understand that as a feasibility trial. That actually helps you, not a lot more effort when you start understanding the barriers. And so sometimes, and that was my mistake, like with the team, we kind of like got excited with this, but then we actually didn't probably invest enough time to realize the barriers and work on them in advance, not necessarily during the process. Learning lessons like everything in life, right? Thank you. We have a question. What are financial resources besides NIH and GrantGov? I would say depending on your project, if it's dental, there are limited amount of funds. And so the ADSM funds would be a great way to fund pilot data and then go to NIH to get bigger grants for a bigger project. So this would be great to fund like a seed grant, like a pilot study. And then after you go to NIH. For those that are orthodontists or actually know an orthodontist, the AAOF, the American Social Orthodontic Foundation. And again, it's not difficult to link OSA mandibular devices with orthodontics, right? And so they actually support up to $30,000. But the goal is to actually support initial steps of big grants, right? And so that's important part, right? So you need to have this preliminary data. And so then some of the specialty organizations maybe have their own sources, right? And again, no harm in applying. And then the rejection is part of the journey, as Nelly is saying, right? And it's just, sometimes it's a good project, but they're better projects. And that's good. Even though it's good for experience and to prepare all the cases, right? So we have here another more question. I don't know if any of you actually can answer, but where are the templates, criteria list to prepare a proposal? I believe it's on the website. There should be a call out for proposals. I don't know the deadlines and the dates, but Megan or Heather could be good starting points. You can also just email a general email to the ADSM asking these questions. They can definitely guide you to the right web page or landing page and have all the information for the actual documents that are required today. That's, I think that's what I would recommend. And please don't ask the questions a week before the due date. So in other words, sometimes it's actually better to, even if you have no idea, ask for the documentation in advance so you can actually be organized and actually start making the questions. Like my experience, sometimes we do last minute and the chances of actually not being able to properly communicate what we want to do is a tricky part, right? My experience with Megan and the team is like they respond within a day, right? But then again, when you start asking favor of extension because you actually make the question the day before, it's not fair, right? Because then it should be, it's a due date. Anyway, it's when in doubt, send an email. They respond quite rapidly. Yeah. And we have another question. Who in the EADSM should we reach out for funding? Again, I think it would be Heather and Megan at the ADSM, but if you email just the general email address, I'm sure they would forward it to the right person. And there is like a scientific committee that judges or overviews this and I think they would get you to the right person and the right documentation. Thank you. Well, I'll just add to that. Since I'm old school, it's one of the few, Heather is one of the few people that I call on the phone and actually have conversations with. And so in that way, my questions and the whole process is greatly expedited. Great. Agree. Great to know. Yeah.

Dental Research Award

choosing a topic

careful planning

realistic objectives

pilot studies

mentors or experienced researchers