I’m joined today by Biostrap’s Chief Science Officer, Kevin Longoria, and the Director of Research here at NeuFit, Dr. Ramona von Leden, to talk about the results from our first published study. During our 6 week study, we used Biostrap’s clinically validated biometric device to measure the effect of Neubie sessions on the autonomic nervous system of participants. Some of the metrics we tracked were heart rate variability (HRV) and resting heart rate (RHR), two major markers for overall nervous system health. Overall, those metrics improved as a side effect of “typical” sessions with the Neubie and without any direct stimulation of the parasympathetic nervous system (i.e., no vagus nerve stimulation, not using our “Master Reset” technique, etc.). We do a deep dive into what happened during the study and discuss some of the implications. For more information on these results, check out https://apnews.com/press-release/pr-newswire/lifestyle-technology-business-health-chronic-pain-3522d00dc5c3bb152dee0f0d25d1cc55
Welcome to this episode of the undercurrent podcast, I’m joined by Ramona von ladened, our Director of Research here at New fit, and special guests, Kevin long Goya, the Chief Science Officer of bio strap, and we’re here to talk today about the results of a first initial pilot study that we did new fit with bio strap. And we used bio strap will give Kevin a chance to share what that technology is we use bio strap to measure the effects of what was happening with people when they just went through basic new fit treatments, nothing special nothing, none of our, you know, master reset or anything especially targeted at the autonomic nervous system. Just basic treatments, see what happens. And let’s dive in and talk about what happened. So Kevin, and Ramona, thank you both for being here. Can we start with you, Kevin? Give me a chance to introduce yourself and tell everyone listening, what bio strap is and why it’s such an exciting measurement tool.
[Kevin Longoria] 2:25
Yes, sir. Absolutely. Thanks for having me on the podcast today. So my name is Kevin Longoria Chief Science Officer here at bio shop. By education. I’m a clinical physiologist and a bit of a quasi-biometric data scientist. So for bio strep, what I focus on is internal and external research and validation, really looking at our biometrics relative to the gold standard, which we’ll dive into here in just a moment.
[Kevin Longoria] 2:47
As well as looking at interesting use cases for wearable technology. So Bio shock, in its essence, is a digital health platform developed to improve human health and performance. So we combine here is clinically validated biosensors, you know, a wrist-worn wearable would be our flagship device, of course, we tend to get put in the bucket of the Fitbit or Apple watches of the world. But what we focus on is clinical reliability. Every one of our biometrics that we measure in output has been validated relative to the gold standard. So when it comes down to clinical research, or perhaps a physician monitoring his patient, we believe that data integrity is of the utmost importance, and really where the wearable kind of competitive landscape has fallen a little bit short. So first, we have these amazing clinical-grade biosensors.
[Kevin Longoria] 3:33
We also combined very unique and very customizable user applications. So the Android and iOS applications, but the customizability allows us to manipulate the user experience and user interface. Understanding that an individual with chronic pain should perhaps not absorb data the same way as somebody just interested in longevity or athletic performance. So we can manipulate kind of how that data is ingested. Because this affects lifestyle modification. To title together, we have this amazing remote physiological monitoring platform, where a physician would be able to log in or remotely monitor all of his patients, or perhaps a fitness professional, monitor his clients. It makes the ability to collect, analyze, and make meaningful use of this data as seamless and efficient as possible.
That’s awesome. Thank you for the overview. And can you give our listeners an idea, you know, when you say, the bio strap is clinically validated against the gold standard? These are some interesting, you know, comparisons. So can you just share a few examples of what the bio strap measures what the gold standard is and how close the strap is to what’s considered to be the gold standard?
[Kevin Longoria] 4:47
Yeah, yeah. So we are currently measuring greater than 65 metrics overall. The primary that the users may be most familiar with would be things like heart rate, heart rate variability, oxygen saturation, and respiratory rate. A little more complex measurement around sleep and activity. But as an example of heart rate and heart rate variability, the clinical gold standard is going to be a 12-lead ECG, right? So when we’re in a hospital setting, we tend to see people hooked up with all of these electrodes and wires, this is always going to be the clinical gold standard, the most reliable way of collecting these metrics.
[Kevin Longoria] 5:20
But it’s perhaps not so feasible when we get to the real world, people can’t walk around with these cords and wires all the time. So the idea of being able to measure this reliably at our risk is very exciting for physicians that will want to remotely monitor their patients. So several years ago, we did a study with Stanford University, specifically looking at our reliability of heart rate and heart rate variability, relative to the 12 lead. So we did find that our heart rate measurements were plus or minus one beat per minute, which is, you know, as close as you can get, to the clinical gold standard. And then the heart rate variability is something we’re constantly improving upon in that clinical validation study was about plus or minus five milliseconds. What we’ve shown is the trend durability, the kind of consistency or precision of these metrics is spot on. When it comes to some of the other metrics, like oxygen saturation, we’re largely comparing ourselves to the fingertip pulse oximetry that is utilized in hospitals, such as the known end device.
And then what about some of the even more sophisticated measurements? Because there’s some interesting, I just want to give people an understanding of the scope of how sophisticated this is. So if you’re looking at measuring blood flow in the arteries, for example, if you’re looking at the vasculature or if you’re looking at VO two Max, that’s an interesting one. Can you speak to a couple of those as well?
[Kevin Longoria] 6:42
Yeah, yeah. So it tests your BIOS chips, a very unique data architecture. So our devices are a little bit different in the sense that they just collect raw data in its raw form, meaning like accelerometer data XYZ, it’s not counting your steps here on your wrist, and we’re sending this raw data up to the cloud. And this is where all of our processing takes place. So without getting too complex, here, we have what’s called our cloud-based pulse engine. So we send raw PPG data, we’re doing complex in-depth analysis, things like beat segmentation beat shape analysis, and we reconstruct a PPG waveform, which looks a little bit like an ECG, but you know, a little bit different to the eye here. by reconstructing the pulse wave and being able to do cloud-based analytics, as opposed to algorithms here on your wrist, were able to do things like second derivative, PPG waveform analysis, and a bunch of big words we’re looking at critical points in the PPG waveform, that allow us to derive much deeper metrics and what most wearable’s can measure. The example that you kind of brought up there is arterial compliance or arterial and peripheral elasticity. So here, we’re able to essentially look at volumetric oscillations of the arteries.
[Kevin Longoria] 7:50
Every time our heart pump has this pumping action, we’re going to see a diastolic and systolic notch. And by looking at specific shape features of this, we’re essentially able to look at how compliant your arteries are. The general concept is when we’re young, we’re active or healthy, we tend to have very flexible, very subtle arteries, that as we get older, we make poor lifestyle choices, you know, consume alcohol, too much whatever this may be. This ultimately leads to arterial stiffness, decreased compliance, and decreases our body’s ability to deliver oxygen and nutrients throughout the body. So by taking these complex metrics, we try to make it a little easier to understand for the end consumer, or in some cases, even the professionals, we can deliver things like equivalent arterial ages. Because this biometric in particular declines very predictably.
[Kevin Longoria] 8:35
With age, we can take your arterial compliance values and compare you to you know, the normal chronological age for that value. So it’s really good to make meaningful use, it’s perhaps difficult to understand your arterial elasticity value. But it’s easy to understand that I’m a 30-year-old male and my arteries are testing at that of a 23-year-old, healthy male. So give you a little bit more reference. On the flip of the coin, it tends to be a good kick in the butt for some people, right? Is it if it’s a little bit older than you attend to get you motivated? Well, it’s great. It’s one of those metrics that tend to move relatively quickly with lifestyle modification, as well. As other examples of complex measurements, we’re doing a lot around sleep, we are doing things like balance testing, reactive strength index, and even vo to testing utilizing our suite of sensors, please do require multiple sensors to get the most precise output that is very unique to BioShock as well.
It’s cool to hear I know in our other conversations, and, when I was visiting with you, at the office, we were able to I was able to see that using the bio strap using the wrist sensor and the chest sensor between the two of those. You can measure vow two and B within a couple of percent of the gold standard where you’re wearing a mask and measuring oxygen exchange right a gas exchange I mean it’s what Would you say it was within how many percent of that gold standard,
[Kevin Longoria] 10:04
About 2.1% for females and about 1.9% for males. So our general concept, you know, taking a step back I, I was in the high-performance area for a long time training World Champion athletes won various world championships in the combat sports. And I always wanted to bring what we were doing call it very expensive, very hands-on training to everybody.
[Kevin Longoria] 10:26
And so at the time, I had access to this multimillion-dollar laboratory. And in our motto here and call it crazy is we believe we can measure just about anything that would affect your pulse waves, anything that affects things like cardiac output, we should be able to measure through through PPG data analysis. So this comes down to understanding the reference values, and then basically going to things like machine learning to be able to predict them through PPG waveform analysis. So we’re just cracking the surface of what we think ultimately we’re going to be able to measure.
That’s awesome. I have one more question before we turn to Ramona and dive into the study here, and we will do one more question. And in case some listeners are wondering, okay, I have this thing on my wrist here. How is that measuring? Deep sleep?
[Kevin Longoria] 11:14
So yeah, sleep is a tough one. Most companies are doing excluding bio straps is relying on what we call autography data. So essentially movement data. And they’re making crude assumptions around things like your sleep stages, light sleep, deep sleep, REM sleep, just simply based on how much you’re moving. If we look at, you know, you’re not going to find a lot of clinical validation with the competitor devices, because they don’t want to prove that it’s inaccurate. But it’s a very crude way, I think we can all wrap our minds around why that’s not the most reliable way to try and estimate your brainwaves. So what we do at bio Shep here is we’re comparing ourselves to the clinical gold standard, which is PSG polysomnography.
[Kevin Longoria] 11:55
And we’re looking at EGS that are interpreted by a neurologist and we’re doing our best to predict your sleep stage based on not only how much you’re moving, it is one of our inputs, but also changes and things like your heart rate and your heart rate variability and even your respiratory rate through utilizing PPG and your movement data to paint a more precise picture. And one thing you’ll notice with bio strep Sure, if people go check out our website we are currently not differentiating REM sleep, we are bucketing deep in REM into one. This is because we don’t believe that it’s possible at this point to differentiate REM sleep based on PPG and movement data alone, we would rather actually not try to report that to people if we’re not 100%, you know, believe that it’s precise.
That’s, that’s interesting. I, I wish that other companies would have that discretion in reporting, waiting until they reach that confidence threshold to report the data. So I appreciate that. Thank you for the overview. I imagine that everyone listening to this will understand, you know, just from hearing you speak about Bioshock. For those few minutes, we’ll understand why we believe that this is a valuable tool, why we care about the measurements that bio strap gives us, and why we were excited to work with you on this pilot study and are excited to continue doing more with you and your team in the future. So let’s turn to Ramona. Now. Ramona, can you please describe to everyone listening? What happened in this study?
[Dr. Ramona] 13:28
You gave a very good description in the beginning that, you know, we have these wonderful training sessions and rehab sessions that we do at new fit. And our initial question was, you know if you’re regularly attending these sessions and making progress on whatever issue you’ve initially come in for, especially if it has to do with pain or range of motion? How is that affecting your autonomic nervous system? Specifically, if you are improving things, like your levels of pain, if you’re increasing your range of motion, is that then in turn, helping to improve your autonomic function? Essentially, is your body in a more parasympathetic state?
[Dr. Ramona] 14:05
Are you more Reno feeling more rested? Are you able to sleep better? And that’s where we saw that BioShock was an excellent tool to use to measure and determine if there were any changes we were seeing. So the basic structure of the study was we recruited roughly 18 participants it was you know, we had we wanted between 15 and 20. For this first round, I think we had 18 total. They ranged in ages and by sex, we didn’t put a cap on that too much. So we had everyone. Some of our participants were 22, all the way up to 61. And then what we had them do was we had them come in, do our normal evaluation, go through finding hotspots and you know, they would all they all had to have some kind of orthopedic pain that they were seeking to improve.
[Dr. Ramona] 14:53
And then we would do two newbie sessions with them. A week for one month. So that gave them a total of eight training sessions. And then they were the BIOS strap before they started their sessions. And it’s important to know all of these participants had not been using the newbie regularly for at least six months, if ever. And so we gave them two weeks before their first session before the evaluation, we have them, start wearing the bio strap wear it every day, to get a baseline, you know what their regular health was in terms of those, you know, biometrics, and then wear it through the newbie sessions, and then continue to wear it for at least seven days following their final session so that we could see if there was any effect of the training that maintained through those seven days, quote, unquote, the washout period, or if it was things that you saw differences specific to those training times.
Awesome. Thank you, Ramona, and Kevin, this framework of two weeks baseline, and then some sort of intervention period, and then an additional week, in the end, is washed out, that’s a framework that you’ve used that the general framework that you use when you’re testing various interventions with the bio strap, right?
[Kevin Longoria] 16:09
Correct. Yeah, so we call this a phase-based intervention trial. So what we want in some of these technologies, it’s very difficult to do, you know, call it a double-blind, placebo-controlled type of study. You know, newbie, as an example, you can’t necessarily put it on somebody and trick them into thinking that they’re, you know, as shocked isn’t the right word, but being stimulated, right, their muscles are being stimulated. So when you come to this type of research, it’s best to establish an individual baseline, and then start an intervention phase and look at basically individual variants from an established physiological set point.
[Kevin Longoria] 16:44
So as remote I mentioned, we did two weeks where no intervention, we just want to follow each one of these individuals, ask them to not modify their nutrition or they’re, you know, exercise habits or anything like that, get it to get an objective understanding of their physiological set point, their heart rate, their heart rate variability, their sleep quality, and everything in between. And then we started our intervention. So for a total of four weeks, two sessions per week, we started to apply these interventions in a very structured manner, we look at basically physiological change. And then as I’m not sure from what I mentioned, is a small washout phase towards the end as well. Are we then actually withdrawing the intervention we try to look at? Was there a lasting physiological impact? Or did it essentially return to baseline immediately? This was the general structure of the study in something we do replicate kind of intervention by intervention, but often would vary the number of weeks in each phase.
And using this framework, what else what other interventions have you looked at using that same sort of framework and the BIOS strap?
[Kevin Longoria] 17:49
Um, so what we’re focused on with BioShock Labs is validating commercial products that we can get behind and that we believe in. So we’re looking primarily at noninvasive wellness technologies that, you know, perhaps want to validate their product, but, you know, are in clinical studies that will take several years to see the light of day, right? Unfortunately, there are some issues with timelines and costs with real clinical validation. So some examples would be the tetragon, by Their body, so percussive therapy, some general you know, research has been done on percussive therapy in general, but not specifically their device.
[Kevin Longoria] 18:22
So we showed in a matter of a three-minute pre-sleep routine, just utilizing it for a few minutes before bed each night. And it increased sleep duration by about four and a half minutes. So perhaps doesn’t sound you know, worth shutting off the mountaintops, they showed that by basically dedicating a few minutes to active recovery saves you time. Another example would be studies that we’ve done with pulsed electromagnetic field therapy, as well as the current study that we’re looking at with low light level therapy, or what people would look at as red light therapy.
Awesome. And that was cool. And when I was visiting your office to hear your kind of point to things and say, Yeah, we validated that that worked. We looked at that didn’t work as well. I think it was cool. It was cool to see. So thank you for sharing that. So we’ve gone through what the study was, what we did, what happened and, or what we did, and now remote, can you tell us, please? What happened? What do we find in the study?
[Dr. Ramona] 19:23
Yeah, um, so there was a few metrics that we found that were, you know, the most exciting to us and the things we wanted to focus on. You know, first and foremost, we were interested in page pain, excuse me, perception of pain, and range of motion. Right? Because with these participants, right, you want them to feel like they’ve had a change. So pain, specifically, the majority of our participants reported that they felt that their pain had decreased throughout their four-week sessions, as well as their range of motion, which I think you know, that’s the biggest question, in my mind in terms of just performance output is, are these patients feeling like they can increase the range of motion? Are they able to feel less pain?
[Dr. Ramona] 20:09
But in turn, then to look at those autonomic numbers, the question is, if they have those improvements is that showing up with sleep HRV, specifically, or their heart rate? So one of probably the most exciting things that we noticed, when we first looked over the data there, was, that the majority of participants showed a decrease in the resting heart rate after there’s this training regimen. And really, their training does not involve any cardiovascular training. So this is just showing, you know, an improvement in their cardiovascular health from the newbie alone. And matching with that was showing that there was this majority of our participants showed that their HRV improved throughout the study as well.
[Dr. Ramona] 20:55
And that one, I think, was really interesting, because, for the first couple of weeks of the study, you saw this increase in HRV. And then it somewhat plateaued, kind of indicating that like these, the participants were adjusting to the newbie, right, their body was adjusting to a new stimulus, and those different kinds of training, and it was showing improvement. And then as their body adjusted, of course, things settled back into like, essentially a new baseline. And then sleep, sleep was the other big one. So we saw an increase in their sleep efficiency, meaning, you know, they just didn’t wake up as much through the night.
[Dr. Ramona] 21:35
And they had more time in deep sleep, which would be indicative of improvements in pain, as well as a range of motion. Because, you know, a lot of times I certainly if I’m in pain will have more awakenings throughout the night. So feeling better is going to, you know, end up showing those same metrics. And so that I was like, Kevin might be able to speak to the bio strap recovery score the best. But that was sort of the accumulation of those metrics, like HRV, and sleep efficiency. And I know there’s one more Kevin, what’s the bio strap has its recovery score that then they sort of show you as you when you wake up every day? And or, you know, look at your biometrics, and we saw that we did see eight average of 7% increase in recovery score. So, Kevin, I’m gonna give you a little moment to talk about that number, because that is something pretty specific.
[Kevin Longoria] 22:28
Yeah, yeah. So the bioship recovery score, it’s a very individualized approach to recovery, understanding, we can’t like to get to people’s data side by side, like a single snapshot of data and look at whose more recovered. So what we do here, kind of a testament to the importance of establishing a baseline is compared their biometric values today for resting heart rate, heart rate variability, sleep efficiency, and sleep duration, they’ll tip to their own trailing five to 30-day baseline. So it’s completely individual. And so yeah, the 7% increase is, is extremely significant. Once again, perhaps these from the outside looking in that it doesn’t sound that significant. But we’ve tested tons of interventions from nutrition and exercise to more expensive or invasive recovery methods. And 7% is extremely significant.
That’s awesome. Thank you. Thank you for sharing that. Ramona, the details there. And Kevin, that commentary? Yeah, that BioShock recovery score. It’s, it’s, it’s cool to hear you describe it, because, you know, people might see that, you know, we have this infographic that we’ll share on the link here. And, people might see that and not know exactly what it is. I think that’s useful to hear you say that. So it’s a combination, you said, of heart rate variability, resting heart rate, deep sleep, or
[Kevin Longoria] 23:50
Sleep efficiency, sleep duration,
Efficiency. So efficiency is how, you know, not being not waking up during the night and spending more time in deep sleep as opposed to lighter sleep stages, that sort of thing.
[Kevin Longoria] 24:04
Yeah, it’s essentially the amount of time spent in restorative sleep relative to the amount of time in bed. So this is going to account for things like sleep latency, how long it takes you to fall asleep, as well as the number and duration of awakening. To me, one of the most important things that we quantified throughout this study was the improvement in sleep efficiency. When you look at what is chronic pain, right? 24 20.4% of the population suffers from chronic pain 7.4% High Impact chronic pain that affects the quality of life, the ability to show up and work every single day, you know, opioid dependence, all these sorts of things.
[Kevin Longoria] 24:41
You look at what is the market physiological factors or phenotypes in chronic pain, and it’s decreased heart rate variability and poor sleep quality, right? Chronic pain in general is marked by a significant increase in micro-arousals and the number and duration of awakening so there’s a lot of research out there, we’ve always really known that sleep and pain are related. But we’re learning more than that sleep disruptions are a better predictor of pain than pain is that sleep disruption. So we’re getting painting a better picture in terms of, of kind of like why pain manifests and poor sleep quality is a big part of it. So the ability to objectively quantify that, yeah, these people are reporting a 21%, decrease in pain, 27% increase in range of motion, these are excellent. We want to understand why I think part of this show is that we’re helping people get more restorative deep sleep, and stay asleep longer. You know, despite the same amount of time in bed, we’re improving their sleep efficiency.
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Thank you, thank you for sharing that I think that’s a really helpful insight there. And one take-home message for me is the quality over quantity discussion. Now someone might think, Oh, I was in bed for nine hours, I must have gotten fabulous sleep. But if you don’t spend enough of that time, in deep sleep, or I think people understand if they’re tossing and turning all night, it’s not as restful, but even if you perceive yourself to be sleeping, there can still be wide ranges in the quality of that sleep and how restful it is and how restorative it can be. So thank you for sharing that. So I’d like to go ahead. Yeah,
[Dr. Ramona] 26:55
Yeah, to kind of piggyback on that too, especially when it comes to you know, that increase in psycho efficiency with working with the newbie, is, it’s almost really exciting. Because we’re, our newbie sessions are very taxing on the body. It’s essentially like a very intense training session, whether it’s for rehab, or, you know, we use it often for fitness training. So if you’re able to then see an increase in sleep efficiency, that’s relating that they’re getting better rest and recovery, which is going to contribute to them being able to improve that performance, with more and more work on the newbie. So it’s yeah, it’s especially exciting, it kind of like compounds on itself that if they can get better rest because they’re working with the new media, they can also train harder because they’re at the Nuvi. So it’s pretty exciting.
To piggyback on that, one of the things that I think is important for our listeners to understand is that when we’re doing, you know, therapy sessions or training sessions, whatever we’re doing, we’re trying to provide a stimulus for the body. And then the body has to adapt to that stimulus if we want to make changes in the structure and function of the body. And the biggest opportunity for adaptation, the most important window of time for adaptation is absolute during asleep, I think everyone would agree with that. That’s when we’re not only restoring energy when we’re remodeling, tissues, remodeling, neurological pathways, when we’re making neuroplastic changes, those happen, primarily during REM sleep, more structural tissue modifications, and improvements are going to happen more during deep sleep. So there’s a lot of importance there.
And it’s wonderful to hear, Kevin, your comments on the statistics around pain and sleep. And then to your point, Ramona, that when people are providing a meaningful input or intervention, that sleep is so important, because it also tells us that they’re having an opportunity to adapt in response to that and incorporate whatever that input is, that we’re that we desire to share with them, that they’re having a chance to integrate it and incorporate that into their body to improve their structure and function. So very good. I appreciate those insights from both of you.
One of the things that we observed, and I’ll see I’ll put this up to both of you and see if either of you wants to jump in and answer it first, is the effect, Ramona mentioned one parameter that kind of increased, and then plateaued. There were a couple of others that we saw that stayed, stayed fairly flat until partway through the study, and then started increasing. And there seemed to be this sort of cumulative effect where the three had to be some sort of critical mass or it seemed like the body had to reach some threshold before those variables would change. Can either of you speak to that and share some more details or what do you think might be happening there?
[Dr. Ramona] 30:00
Yeah, I’m going to start with the one that I realized we didn’t mention in sort of the reporting of the initial state findings. One that we thought was interesting was peripheral elasticity, which Kevin spoke to is, you know, kind of being, it’s a hard thing to wrap your head around, but our chill age and elasticity of your arteries speaking to nurture their health. So we saw that at the end of the four weeks of training, there was a significant increase in peripheral elasticity. And then it continued to increase a little bit into the washout as well, which kind of spoke to that ramp up of, you know, the body adjusting and then showing those improvements. But it did take a little bit of time before that started to show up. But as we were ending the study, you can see it kind of continued to climb up, which is pretty cool.
[Kevin Longoria] 30:47
Yeah, I think to expand upon your previous point, Jared, it’s important to understand stand the difference between the stressor phase in the adaptation phase, people in general, and I’ll take athletes as an example, very good at applying stress, not so good at understanding that adaptation occurs primarily during phases of sleep and recovery. Right. So when we take for resting heart rate, for example, the newbie is a stressful kind of thing on the body, right? This is what forces adaptation. So when we looked at the first phase of the intervention phase, we saw an acute increase in resting heart rate, very similar to actually what we would see from taking somebody from sedentary to active, their nocturnal heart rate will slightly increase.
[Kevin Longoria] 31:28
But over time, it takes a while for the body a little while to make these physiological adaptations, or by the end of the intervention phase. And throughout the washout phase, we saw day-to-day improvements in heart rate variability and decreases in nocturnal heart rate, which is what we love to see we’re showing less systemic stress improve, you know, cardio-respiratory efficiency, but these do not happen during the stress phase. So it’s important to look at the intervention as very important, it’s a very necessary step. But that wash-out phase to me was one of the most important because we looked at the body’s ability, in the absence of the intervention, is it continuing to adapt. Or is it basically, you know, relying on the intervention itself?
[Dr. Ramona] 32:08
Yeah, and I believe, Kevin, that some of the data as well, as we looked into that wash-out data, which was important, we want to see that you know, that those improvements are continuing to happen. But then, towards the end of those seven days, some of those improvements, like the deep sleep time, started to return to baseline levels, which kind of speaks to the complement of training with something that’s a stressor and very challenging to the body. But that stimulus, improving deep sleep, but you know, it’s a balance. This is why we wouldn’t train every single day, you need the time to recover. But if you stop training altogether, those improvements in your measurements are going to start to go back down.
[Kevin Longoria] 32:46
Yeah, yeah. Great point. And I think that’s, you know, a testament to another reason why we did this study, we want to understand specifically how people are adapting to it. So we can learn more and enhance our protocols. Exactly. If we were to, you know, stack session after session day after day, we’re not giving people enough time to adapt. So by actually looking at the data changes in between the sessions, we’re getting better insight into how the technology is working at a physiological level.
[Dr. Ramona] 33:11
And similarly, I mean, we did see, speaking to that recovery time that wash out, when we talked about our participants showing an improvement in their pain scores and their range of motion. You know, we did see some improvements during the training itself. But really, the biggest changes were what was seen in that washout in that time, when now they’ve kind of gone through this intense four week, you know, intervention, and now their body’s having a chance to fully recover, that’s when you saw them start to report these bigger changes in those scores.
[Kevin Longoria] 33:40
Yeah, that was very interesting. And I think important for another thing for, you know, people listening to understand that the pain did improve during the intervention phase, there was actually when we stopped the protocol that we saw the most significant and lasting improvements. That was very interesting. I think that’s why there’s you know, there’s a benefit to packages instead of somebody coming in for a single session, because, you know, they expect their pain to decrease very quickly. And that’s just not quite how the human body responds to this type of stimulus.
[Dr. Ramona] 34:10
Right, exactly. I mean, that’s something right, we don’t have someone come in and say, we’re going to solve your problem today, it’s going to be consistent work. That’s, you know so that your body adapts, and then those changes, they last longer and longer, the longer that you consistently work on them.
It’s cool to see that, you know, a lot of these things that we read about in exercise physiology textbooks about stressors and adaptation and super compensation, it’s cool to see them come to life. And one thing that I’ll mention just for our listeners here, is that there’s a lot of overlap between effective therapy and effective training. Because our goals are the same. We’re trying to remodel tissues to improve movement and coordination and speed and strength and get the body into a state where it can adapt that adaptation might mean healing an injury or might mean building bigger muscles are stronger connective tissue, you know, whatever it is, but the goals are so similar.
And so we sometimes talk about therapy sessions as training sessions here and vice versa. Because there is so much overlap. And looking at a lot of these underlying health parameters, a lot of this is in the exercise physiology realm. And I’m part of why I’m excited about this study is that we’re bringing this line of conversation and this line of analysis into the physical therapy, orthopedic chiropractic space, where there often is not any sort of, or it’s not part of the dialogue very often. And I think that’s, I think that’s a cool piece of this line of inquiry, and one of the impacts that I believe we’ll be able to have is kind of shifting that dialogue. So really good insights. Thank you both. Let’s turn now to what conclusions can we draw. So we already talked about this as a pilot study, Pete, you know, a wide range of ages in participants and had all sorts of different types of pains or symptoms when they were coming in? What conclusions can we draw? What conclusions can we not draw? How would you interpret this? I’ll start with Ramona, then we’ll go to Kevin.
[Dr. Ramona] 36:32
Sure, I think yeah, there you nail on the head when you’re doing a, you know, bigger study or something, you do want to kind of pare down your variables as much as possible. So obviously, here, having a broad range of participants, you know, both male and female participants, different levels of pain is going to add some changes. But that’s the importance of having that baseline data, as Kevin spoke to earlier that allows us to kind of, you can compare anybody’s reported changes back to themselves and back to where they started. But I think, you know, we just spoke about the changes that we started to see happening over those four weeks. And a lot of times when we have people come in for sessions, we usually suggest, you know, four to six weeks of regular sessions before you can have that change.
[Dr. Ramona] 37:19
And I think this speaks to that. But it takes roughly a month before you start to see those big and lasting changes to the body from your rehab or training sessions. So you know, if we were to go forward and do another study, Kevin and I have talked about going out, maybe make it a six-week study, so that we could start to see how those changes, we saw it four weeks, if they continue to change with two more weeks of training, and give it that time to really spread out and fully evaluate it. And so I think that also, a lot of times when we put together a protocol, we tend to look at, you know, 10 to 12 sessions, so it’s five to six weeks. And this supports that, that says that like that is about right, we shouldn’t be giving 10 to 12 sessions to start to see those big changes. So that would be my first one. Kevin, if you want to take a go? Well, I’ll think of more.
[Kevin Longoria] 38:10
Yeah, I think what we learned is, you know, it is eliciting favorable physiological adaptations, we did not necessarily have the population size of everything controlled low enough to shut off the mountain tough statistical significance. But every metric that we cared about was moving in the proper direction, specifically, heart rate variability, we saw day-to-day compounding improvements.
[Kevin Longoria] 38:33
So if we were to extend the intervention phase a little bit longer, there’s no doubt that this would have reached statistical significance. But the fact that we also saw the decreased resting heart rate, which the AJ will tell you all day, run as low of a resting heart rate as possible. Improvements in sleep efficiency confirmed what we essentially already knew around pain and range of motion and such. But just to look at every single one of our metrics to see everything trending in the right direction and no maladaptation nothing where we saw that were perhaps introducing some unknown risk to the participants. It’s always good to look at these variables as well. I think it confirms once again, what we already know, we’re directly impacting the autonomic nervous system. Now, it’s about bringing it back to the drawing board and just refining our protocols a little bit.
[Dr. Ramona] 39:19
Yeah. And that that will nicely lead into one other condition that we have is that you know if we want to evaluate the movie’s effect on the autonomic nervous system, we have protocols that [Garrett] mentioned at the very beginning of the podcast, like the master reset, which the whole goal is to work and, you know, improve and support the autonomic nervous system.
[Dr. Ramona] 39:40
So if that, you know, going forward with those next steps in the next stages of what we want to look at, and I think that maybe we start to evaluate, do we want to use a protocol that’s specifically aimed at that or do we want to continue to evaluate what we have can do and if this is sort of a side effect of the regular training sessions, Is that you’re getting improvements in autonomic function? Well, that’s awesome.
Kevin, can you speak to me? I know, it’s anecdotal, very informal. Very rough. Can you speak to that one day one time before and after an intervention that you tried with the Master Reset just to speak to that’s something for in case everyone doesn’t know, it’s like remote aside, it’s a protocol that we use that is specifically intended to stimulate the parasympathetic nervous system.
It’s sort of like if you do a guided meditation or breathing exercise to shift, shift down the fight or flight response and increase the rest and digest side of the nervous system. This stimulates the vagus nerve and is meant to amplify that sort of thing. Can you speak to that? And with the caveat that it was very rough, you just did it with people in your office? But
[Kevin Longoria] 40:52
Yeah, yeah, of course. So I’m specifically what I was very interested in, in that particular little pilot study, we’ll call it was the acute effects of the master reset. Right. So this study was more focused on the chronic, you know, nocturnal benefits, the, you know, adaptation over time, I wanted to see before and after, what is this doing to my body. And I will tell you, it was one of the most profound experiences from a data perspective, I didn’t necessarily walk away from it feeling extremely different. When you looked at the data, and you saw this profound increase in arterial elasticity, blood flow, right?
[Kevin Longoria] 41:26
Acute, I think it was 30% or so improvement in heart rate variability right off the bat before and after, decrease in resting heart rate increase in oxygen saturation, every single metric that I care about, and value from a health perspective, had an immediate acute impact. And I had tested, you know, very expensive, more invasive, trans cranial deep brain stimulation, and all these making claims about the ability to affect your nervous system immediately. And I essentially disproved every single one of them, because my thought process going into this, as you can’t manipulate the nervous system like that quickly, that profoundly. And I stood corrected, and was so pleased that you know, getting them by, and I’ve stayed good friend since then. And I think that’s ultimately what led to this study as well.
I think I’m sold on that should be the next one that we do there. But so far for, for everyone who’s want to kind of know, you know, as a newbie is using this, you you’re familiar with the master reset, for those of you who aren’t, it is sort of like electronic meditation is something that we call, you know, you’re lying down with electrodes on, two of them are going to be at the back of the neck. So we’re going to stimulate the vague nerve. The other two can be elsewhere on the body, typically, you know, not on the feed or the hands, but you know, typically head to toe. And we do see these cool shifts as Kevin described there.
So the good news is that we have plenty more to study as well. So we had an exciting pilot here, and there’s more content more fodder for further study. So thank you both, for sharing what happened in the study and sharing your perspective here, Ramona. It’s a pleasure working with you, our director of research and clinical education. I think I left that off when I introduce you. And Kevin, the brilliant Chief Science Officer of bio strap and bio strap labs. Thank you both for joining us. And thank you everybody for tuning in and listening to this episode of the undercurrent podcast. Thank you so much for listening to the undercurrent podcast. If you enjoyed this episode, please consider leaving a review and be sure to subscribe to stay up to date as we release future episodes.