6 ms·
Ouch! But I appreciate the feedback, as I just stated in another comment. If you look on our website, we describe the process of increasing the synchronous fir
by pedalpete 1y ago
Ouch! But I appreciate the feedback, as I just stated in another comment.
If you look on our website, we describe the process of increasing the synchronous firing of neurons which are the defining feature of deep sleep and the foundation of health.
Unfortunately, we thought we'd have FDA regulatory approvals prior to launch, but we won't, which means we can't legally point to any specific biomarkers or physiological processes.
It's a bit of a strange rule, because if the person was conscious while we provided the stimulation, we can say whatever we want, but because they are unconscious, we have to kinda dance around it.
I'm still working on how we can clearly say what we do, while staying within the regulatory limitations.
It's a big part of why I'm putting stuff like this out now. Your feedback has been really helpful, and I appreciate it.
- al_borland 1y agoSorry. I hope you can understand the skepticism. There are a lot of people in the health space just looking to make a quick buck, so my BS meter is always on high (as are many others). This is something you’ll need to contend with at launch. I’m not saying this is you, but extraordinary claims will always meet resistance, especially if it doesn’t seem like something is being hidden. I just took a look at more of the site. I’m not sure if changes were made based on feedback, or if the site has remained the same, but it mentions tones being used to single the brain to adjust. This was what I was looking for, but you seemed to dance around it in the comments (or maybe I somehow missed it in the blog post and comments?). If you can mention it on the website, I’m assuming it’s not part of the FDA restriction. Having learned that, I’d have a follow up question. I sleep with a white noise machine. Others may live in a city with street noise at all hours of the night. Will something like a white noise machine, or street noise, mask (or interfere with) the tones the headband is making, or dampen the impact it has? I wouldn’t want to give the white noise up, as it has helped me a lot, especially in unfamiliar environments. It gives my brain something neutral to focus on while trying to fall asleep, instead of activating at every little house or street noise that might be going on. One of my biggest issues is going to bed and then falling asleep. If I fail to do that effectively, I wouldn’t even get to the part where the headband could do its thing. If it takes longer to fall asleep using this, does the effectiveness mean a person can feel as rested, with similar performance (memory, etc) on less sleep? The blog stressed how time sleeping is the wrong metric, but would this cut the amount of sleep a person needs, or would they still sleep for a similar duration, just with better quality? I don’t think sleep duration can be thrown out, as people need to organize their life around sleep.
- pedalpete 1y ago100% I understand the skepticism, and I actually invite it! There is so much snake oil, and BS, it's a big issue we need to address. The current website is not regulatory safe, but because we aren't selling yet, we're at little risk. So you're seeing our old website. The new one unfortunately can't talk about deep-sleep, slow-waves, etc. We can talk about timing to brain activity, and that sort of "talking around what we're doing". If falling asleep is your biggest issue, than what we are currently offering is not for you. We're talking to other researchers (there is a bunch of neuro in our office), but the "fall asleep faster" stuff I've seen is mostly nonsense. BTW, I'm a life-long insomniac, that's how I got into this. We try to stay away from the "sleep less" terminology. Yes, your brain functions better as a result of stimulation. This has been shown in multiple studies, but the position we like to take is that I'm not the police of your sleep time. You decide the time you have and how sleep fits into your life, we ensure that time is as restorative as possible. This fits with young parents, shift-workers, etc. Some insomniacs will decide that this is how they want to deal with the lack of sleep, but I'm not putting insomnia as a primary target because we can't answer the primary complaint of not being able to fall asleep. As far as white-noise machine, it shouldn't affect the stimulation at all. People often ask us "what does it sound like" but the sound itself is only 1/10th of a second or less. The volume is important. Not loud enough, and your brain will ignore it, too loud, and it will wake you up, so we are constantly adjusting the volume based on the brain activity we are reading in real-time. The sound would/should be perceived as louder than your white-noise maker. It's possible if your white-noise maker is REALLY loud, the speaker just might not have enough power to overcome that, but I think that's unlikely. Internally we're talking about having noise, podcasts, etc being available to be played while you're trying to fall asleep, and once we've detected you are asleep, we turn that off, and move into stimulation mode, however, we have to be aware of battery consumption (bone-conduction uses a not insignificant amount of power), and that Apple doesn't expose BLE Audio to devices other than AirPods, which adds to the battery drain. We have some solutions to this, but it may be a post-launch update.
- al_borland 1y agoYou say you try to stay away from “sleep less” terminology, but your central point so far has seemed to be that the idea of sleep duration and the 8 hour sleep window is junk science and should be thrown out. Anyone reading your dismissal of the 8 hour sleep window is going to take that to mean that your product doesn’t require 8 hours of sleep. The assumption will be fewer hours of sleep are required. If this isn’t the take away, then I’m not sure why you spent so much time trying to dunk on sleep duration being the enemy and needing to move the conversation away from it. It really sounds like what you’re trying to build compliments sleep duration and proper sleep hygiene. The way it’s been talked about makes it sound like someone can replace a full night’s sleep with a 20 minute power nap. That may not have been your intent, and you didn’t explicitly state that, but that’s sure what it seems like you’re trying to place in reader’s minds by dismissing sleep duration and hygiene as old and irrelevant ideas.