Virtual Reality for Better Sleep? Podcast with Kelly Roman

Guest

In this episode I speak with Kelly Roman. Kelly is co-owner of Fisher Wallace Laboratories, a progressive medical device company that aspires to treat insomnia and depression in novel ways. Fisher Wallace is introducing a device that combines neurostimulation with virtual reality for better sleep. It will be called Kortex. This device non-invasively delivers a low dose of electrical stimulation, combining this with virtual reality for better sleep. The purpose of the virtual reality stimuli is to help induce relaxation.

Virtual Reality for Better Sleep: Kortex

Unlike reading on your phone, Kortex might actually help you to get to sleep faster and experience deeper and more restorative sleep. The idea is that Kortex stimulates the brain to produce melatonin while lowering cortisol, thus helping people manage stress and sleep without prescription drugs. To learn more about the product and the research leading up to it, check out my interview with Kelly below!

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Transcript

Kelly Roman - 00:07: If you wear a Fitbit, you have your sleep tracker and you can see how many times you woke up in the morning, then what do you at that point? This is a wearable that actually can solve problems. It doesn't just give you the data about the problem you have. You can do something about it.

Kendall Kendrick - 00:24: Human OS. Learn. Master. Achieve.

Dan Pardi - 00:34: Can a device help you get better sleep? That's the subject of our show today. You may recall a few episodes back I did with Professor [Zitzer 00:00:42] at Stanford, we discussed lights, circadian rhythms, and a new wearable device that can cut the days required to adjust to a new time zone- In other words, cutting jet lag, in possibly less than half. In other words, if you traveled from San Francisco to London, it usually takes six days to fully adjust. This technology can help you fully adjust in three days or maybe even less. That is huge news for regular travelers but this technology can also be used for teenagers who naturally want to go to bed later but still need to wake up early for school and even for people who do regular shift work. Even though their bodies are not being transported across time zones, for all intents and purposes, flip flopping between night and day shifts is the same as time zone travel but without the plane. Pretty exciting stuff here.

01:28: Today we're going to talk about another technology that can help you sleep. One of the biggest complaints I hear regularly is people having a hard time shutting down at night. While the former technology I was referring to uses specifically timed light pulses to shift your circadian rhythm super fast, this is a neuro stimulation device you wear like a headband one or two hours before sleep to help the mind relax. I've not tried either of these devices as neither are commercially available but they should be available this year.

01:57: In the last show with Professor Zitzer, we discussed how this new breed of wearable technology not only measures and reports on sleep which, don't get me wrong, can be very valuable for dialing in good sleep behaviors, but this next gen of devices may actually influence the quality and timing of sleep itself. It's an exciting world we live in so without further ado, I bring you Kelly Roman, the co-founder of the company of Fisher Wallace, who will be bringing a neuro stimulation product called Cortex to the market mid-year to help our minds relax before bed. Kelly, welcome to Human OS Radio. Tell us about your company Fisher Wallace and your neuro stimulation product.

Kelly Roman - 02:34: Fisher Wallace manufactures one device and one technology and we just launched a second one, Cortex, which I know you want to talk about. Since 2009, we've marketed a device called the Fisher Wallace Stimulator and that is basically a handheld neuro stimulation device that then has a couple of electrodes that come up from the handheld device and slip under a headband above each temple. That device is defined as a medical device. It has FDA clearance to treat depression, anxiety, and insomnia. It runs on two AA batteries. The patient wears it for 20 minutes and in that 20 minutes they receive a low dose electrical stimulation between one and four milliamps, which is very comfortable. At level three and four, you can feel some tingling but it's not an uncomfortable experience.

03:19: The device employs multiple frequencies, two of which are patented and about six of which are not. They're trade secrets. The combination of those frequencies allow the electrical current to pass through the bone matter and at the temples it's one of the thinnest parts of the skull. It's one reason why we placed the electrodes there. Also, the frequencies can modulate the physiological effects so you don't quite feel the stimulation on the surface of your skin as much because of the frequencies. Also, the most important aspect of the frequencies is their ability to stimulate neuro-chemical production, dampen the default mode network, which right now, what we understand is the mechanisms of action for this device.

03:58: This stimulation has been shown to reach all the way to the center brain, thalamus, basal ganglia and we have studies that show durable increases in serotonin, melatonin, gaba, and reductions in cortisol. We've also over the years conducted a number of studies on effectiveness and safety. Of note, we had one clinical trial we did at Mount Sinai that was published in 2015 on Bi-Polar 2 Depression, the most difficult form of depression to treat. It's very resistant to drug therapy. One of the reasons for that is anti-depressant medication, SSRIs, often amplify the mania and hypomania sides of Bi-Polar Disorder. Even if they are successful in reducing the depression, which they're only successful about a third of the time doing, they can often trigger the mania and hypomania and cause other side effects.

04:50: It's well known in the Bi-Polar clinical and research circles that this is a very difficult form of depression to treat. One of the leading Bi-Polar researchers, Edward Gallagher, conducted this study about cyanide, used double-blind placebo controlled and all of the subjects that received active treatment had a large effect size on the Beck Depression Index, which is basically a gold standard depression measurement tool that's self reporting for the patient. All the patients who had the active treatment had a big effect size there. There were no incidents of side effects of all, no hypomania, no mania. We have to do a larger study to make that definitive but that was a landmark study for neuro stimulation and there are six million people that have Bi-Polar in the United States.

05:31: We also did a 392 pilot study in Phoenix House in 2009. They had patients of all different kinds of drug abuse, cocaine, heroine, alcohol. They gave two-thirds of them their regular treatment protocol and about a third of them got the device. The group that got the device remained in rehab after 90 days at a rate 50% higher than those that did not get the device, who just had the regular treatment.

05:57: When you're seeing that kind of enormous increase in retention, that's very valuable for a lot of reasons. First of all, there's a correlation between retention rate, how long you stay in rehab and whether or not you're going to leave and go back to abuse. There's a high correlation there between staying in rehab and success longterm. We actually had another study that's going to be double-blind placebo controlled under tension at a major drug rehab center. We can't announce it yet because it's going through the board for approval but we expect that to be approved this year and have results by the end of the year.

06:30: There's a hundred subject sleep study going on at University of Texas that's fully funded by the university using our device to study insomnia. We have some good research in the pipeline. We have some very good research that's already in our portfolio and we've been able to leverage that with modern direct-to-consumer digital marketing techniques to build the business, drive people to our website, educate them on the technology. You need a prescription in the US. It's actually not as vigorous as for a drug. It doesn't have to be from an MD, it can come from any licensed health care practitioner. An acupuncturist, a psychologist, a licensed social worker. The next step is building some digital health services around our product and app.

Dan Pardi - 07:13: You have a new device that's coming online that's called Cortex. Tell us about that.

Kelly Roman - 07:17: Cortex is a neuro stimulator that uses the same technology as our first generation device, so same technology as the Fisher Wallace Stimulator. But, from an industrial design perspective, we designed it so it can attach to a VR headset. The reason why we did that is because a.) we were seeing over the years there's been a lot of very interesting work in VR therapy with patient populations that we're already treating, PTSD, substance abuse patients. There has been a lot of work and a lot of published research on VR therapy. Mostly in exposure therapy.

07:49: We saw an opportunity to combine our clinical success as an intervention with the success of content. We designed a device that can fit comfortably on a VR headset. They did lower the maximum stimulation from four milliamps to two milliamps. Again, we did that because once you go over two milliamps, you really start to get some optic nerve stimulation, which is safe, but you don't really want to have that while you're experiencing VR. But we're not sacrificing the clinical benefit that's been shown in the research for instance. We are planning to ultimately come out with a prescription version of Cortex. We started with the ATC versions.

08:30: Cortex is intended to help manage stress and sleep. It's not a medical device. It's a general wellness device. But it benefits from the fact that it clones the technology of our first device and so you can see for instance that all the studies we did with the first device were at two milliamps or less. The buyer market evidence, all the forms of evidence are relevant. We're able to market the buyer marker evidence when we're talking about Cortex because that's not a medical claim. We can't go out and say Cortex treats Bi-Polar Depression. We're not allowed to do that. We're not going to do that. We don't need to do that. We have a first generation device that is making medical claims and is regulated by FDA.

09:10: Cortex is really designed for more of your everyday consumer who wants to improve stress and sleep. From a content perspective, I think there's two avenues that are very interesting. One is kind of the pure consumer avenue in pairing relaxing, engaging, meditative type content to amplify the experience of using Cortex. We partnered with US2Games. They're well known for monument value and they created this great VR game called Land's End, which when I first experienced it, I felt relaxed within 60 seconds. Then I started the electrodes under the VR head strap, just from our first generation device because we have these electrodes that already go under a headband, and I experienced it in combination. It was a very peaceful experience. I reached out to Us2Games. They were very responsive, very receptive.

09:59: The more medical avenue of pairing it with VR therapy, like exposure therapy for PTSD, that's going to be something that needs to be investigated in a research setting and we're talking to some of the top researchers, like Skip Rizzo at USC who's done a tone of VR therapy research. We want to get these Cortex devices into their hands and give them a tool that they can use in their research. But right now, we have a great product for stress and sleep and we hit our Indiegogo goal in six days so we've definitely gotten some good press and we're going to release it certainly by July, maybe a little earlier. I think we're going to continue to get more and more interest in this product because it's something that actually works, actually is an intervention.

10:38: If you wear a Fitbit and you have your sleep tracker and you can see how many times you woke up in the morning, then what do you do at that point? This is a wearable that can actually solve problems. It doesn't just give you the data about the problem you have. It can do something about it.

Dan Pardi - 10:51: As a sleep scientist, a common question I get is how to turn off before bed. For a lot of people that just don't have a clinical sleep issue, this is their issue. Their minds are still racing about some problem they're working on that day or worry about something that they need to do tomorrow. Having a device that can enhance relaxation techniques, which we know to be effective, I think that could be a big win. I can imagine everyone having something like this in their bed table drawer that they use when they need it. Sure, some people would need something like this more regularly but a lot of us experience something like I just described on a semi-regular basis, perhaps weekly to monthly. This sounds like it could really help.

Kelly Roman - 11:27: Alternating current has been shown to dampen that default mode network and that network is very active when you're stressing and thinking about work. That is what is damped naturally when you bring your attention to something external and that's where rapid eye movement therapy has had some benefit. Our device is working physiologically on the brain in that way.

11:49: One of the things I really like about Land's End is if you just look at the color pallette, it's using those orange tones that have been shown to help you wind down. You don't want to have a bright cell phone in your face right before you go to bed. But an hour or two before bed, you can use Cortex, experience Land's End or some of the other content that we'll curate. We'll be very careful to make sure that that content from a visual perspective is something that will help you relax.

Dan Pardi - 12:16: That is important. Getting light right into the eye is a signal to stay awake. The fact that you guys are mindful of that, are using tones that are less stimulating, pulling out as much of that blue light that you can. But I imagine a rust colored desert setting would lend itself to favorable color pallettes for that environment. Yes, the idea is you'd use this perhaps an hour before you intend to go to sleep and that relaxes the mind and that can help you quiet down some of the areas that are overactive and you get better sleep.

12:44: You guys are releasing this in July, you said?

Kelly Roman - 12:47: We're releasing this in July, but from the manufacturing point of view we're not reinventing the wheel here. We feel pretty confident in that timeline.

12:55: If you have better quality sleep, you can often have a little bit less of it and feel even more refreshed. From the 20,000 patients that we've treated with the Fisher Wallace Stimulator, that's a common feedback that we get. We distribute all of our devices directly to the consumer and so as a result, we're in touch with these consumers. We have a tremendous amount of insight into what the experience is and I know, for instance, that the soldier who is talking about his experience on our Indiegogo video. He's a four tours of duty Iraq and Afghanistan, terrible sleep issues until he started using our technology. He said that his sleep at six hours, he felt like he slept for nine in terms of his energy level.

13:38: I also think who doesn't have stress? Even if you feel like your sleep is completely perfect, this can be used in the morning. It can be used at any point in the day, where you just really need to take it down a couple of notches. You know, those kinds of things are really important for a healthy lifestyle as well.

Dan Pardi - 13:54) It can be used before sleep, it can be used in the middle of the day as more of a relaxation facilitator. I'm really excited to see the device come onto the market. 50 to 70 million people that have diagnosed sleep problems in the United States but there's still a lot more people that still battle with imperfect sleep every night so this might help a good amount of them. Thank you for the work you do and coming on to explain it.

Kelly Roman - 14:15: Thank you so much, Dan. I really appreciate the opportunity.

Kendall Kendrick - 14:20: Thanks for listening and come visit us soon at HumanOS.me.