I'm Andy Rink, I'm a Stanford Biodesign fellow. I'm a physician; I'm currently in my general
surgery residency. I'm Varun Boriah, I'm a specialty fellow at
Biodesign, I'm a mechanical engineer by training. The need area we're working in is to treat
sleep terrors in children. They essentially are like a really severe
nightmare that kids cannot be awoken from. The last up to 30 minutes and can occur nightly
and they're different from nightmares because they happen during deep sleep versus a nightmare
happening in REM sleep. So that's why the children can't be woken up because they're
stuck in deep sleep, so they're very severe and hard for the parents to watch and they
really start affect the parents' quality of life.
So what we're able to do is strategically change sleep stages during a normal night
of sleep and by doing that able to cure sleep terrors.
One thing that was really great about this project was that we were able to very quickly
get into user testing. the solution that we ended up with is a fairly
low risk solution where we were able to essentially build a functional prototype with mostly off
the shelf components our concept was vibration based and so we
got off the shelf vibrating alarms for deaf people and ended up testing with that.
what we're looking at doing is something that has been used in consumer products and sold
commercially for a long time…
… We're just testing applying it in children with night terrors…
….there's a long predicate of this being a safe approach…
The clinical literature gave us confidence that the mechanism of action we were using
to treat these users was effective and so we asked ourselves the question of can we
use this technology to achieve that mechanism of action and we could answer that question
with a scientific study. the clinicians we talked to were very interested
in doing the studies and we had great buy-in from all the children's sleep specialists
that we talked to. I think that that's when we really decided to push doing the user testing
and go through the IRB. the first step was to go out and find principal
investigators who were excited about the project and who were willing to engage with us
And then went about writing the protocol itself deciding who the best users to enter the study,
what would be the criteria we would use to evaluate those users, and then establish what
the testing protocol would look like. The testing involves a initial visit, the clinic,
followed by a two-week baseline monitoring period and a four-week use period and subsequent
follow-up for two months. we designed the study to test the feasibility
of our technology. We want to see if our solution will achieve the effect that we want in these
kids with night terrors. So we've worked with a statistician and we have found kind of what
the minimal number is that we need to be statistically confident and have statistical significance
that we have been able to have some sort of an effect.
So we recruited through both through physicians and also just through the general public.
we contacted pediatricians at Stanford, we contacted pediatricians in the local area,
and they were all very positive and interested in recruiting for our study, and we've had
a good amount of patients brought in through that method. We've also recruited largely
through public means; we put up flyers in a lot of places, all over campus, we've put
them up in, at day schools or in preschools, we've put them up at the train station, literally
all over Palo Alto and the surrounding area. We've also done a lot of on-line recruiting
so we've had posts in some of these parent networks, some of these parent support groups.
We've done some traditional google ad words recruiting, we've, and some word of mouth.
We're starting to do some social media recruiting, so all these have been various ways of just
reaching the general public. the ones that come through the general public
take a lot longer to be ready to be enrolled in the study. it takes a lot more work, there's
more excluded through that route, but that's where the parents are, they don't necessarily
go to their physician.