A new device to screen for sleep apnea : your opinion ?

[pierre.gilfriche]

Hi,

We are a start-up at Oxford University and we are developing a new way of screening for sleep apnea using only a pulseoximeter (the wrist-like sensor that measures your oxygen saturation) that sends data on a smartphone via bluetooth (so without any wire). The phone then sends the data measured on an internet server where it can be analyzed by your doctor or a sleep clinician.

Our goal is for it to be really simple of use, cheap and fast : you get the device for about $50, you install the app, click on a few buttons, sleep and this is over. It won't replace the polysomnograph as the data obtained is not sufficient (even though we want to be fda cleared), but you would be able to know if you are "at risk" or not, so you would know whether to go further.

As I think most of you had to go through the process of the polysomnography in clinic (or at home but with all the wires etc.) I would like to have your opinion on our project :
-do you think it is a good idea ?
-would you have used it if you could ? Or would you have preferred to go directly to the sleep clinic ("might as well do the big thing directly and that will be over")
-do you use apps generally ? would you trust a medical app ?
-about the way of getting it : would you rather rent it to your GP (~$50) ? buy it directly in a pharmacy for you to be able to make several analysis to screen your condition regularly (~$120) ? (If you have other price limits that would also be intersting to know !)
-Would you rather pay for the device and not for the app ? Pay for the app and not for the device ? Or a bit of both ?
-Would you be interested to buy this kind of device now (if you already not you have sleep apnea) to follow the evolution of your condition ?

These are the general things we wonder, but if you have any other remarks or things to add that would be really helpful, and if you have any questions I will be pleased to answer you.
And don't hesitate to be honest if you think it's a bad idea or if you think some things are not good, the goal is to help people like you so every feedback (even bad feedback) is interesting

Thanks a lot !

Pierre

[retired_guy]

Develop it, contact Fitbit, Nike, or whoever and interface your results to their "fitness" apps, and sell it on Amazon. You'll do well.

I don't think you'll get a lot of acceptance from the medical community. Too little data to give them that 'wow' factor.

But, $50 bucks on Amazon and it'll tie into my Fitbit stats? I'll take two.

[PsychoMike]

Making it easier is a good idea, but I know you wouldn't be able to catch Upper Airway Resistive Syndrome (a variation on the obstructive sleep apnea theme) because there isn't a sufficient drop in O2 sats.

Also, considering the Level 3 (at home) screening test was free (through the DME) and can be done with a fairly minimal equipment (the unit I used was basically a small box strapped to the forehead (pulseoximeter and sleep position detector) as well as a short nasal cannula to record breathing rate), it'd be hard to get much better.

I like the "think outside the box" idea, Pierre....but I just don't know how much room there is for an additional screening tool between the "10 questions" surveys and the Level 3 test.

[pierre.gilfriche]

Thank you for the answers !
Concerning the Fitbit and everything, that's still an option but as we really want to make an effort to make it medical and not just for fitness. The "strength" we have here and is the fact that we have worked hard on making it acceptable (even if not accepted yet) as a medical device. I agree though that the real challenge is to show the medical community that even with small data we can something really valuable.

retired_guy, for you what we lack (compared to fitbit) is that we wouldn't be of enough use for you is that it ? Whereas if it is on Fitbit you already have a platform you use so it would be like an upgrade, am I right ?


PsychoMike : yes, Upper Airway Resistive Syndrome is pretty much in the dark zone for us ("diagnosis : we don't know !") but we are working on it and we hope we can still detect it. What makes you say it is impossible ? Have you already tried this kind of analysis ? Or have is it just that the O2 drop is not significant enough to be distinguished from normal ups and downs ?

Concerning the price I also that can be a problem, we also consider selling it to sleep clinics (because that would be cheaper for them!). Ha and I notice you are from Canada, I think that people from the US would benefit a bit more depending on their insurance as it is not always completely reimbursed.
We also want to work on the fact that we can give the device and provide a diagnosis very fast. How long did it take for you ?
I agree that the at-home tests are now rather simple but I think some people still find them uncomfortable (the nasal cannula must not be very pleasant to wear), what do you think ?

[PsychoMike]

PsychoMike : yes, Upper Airway Resistive Syndrome is pretty much in the dark zone for us ("diagnosis : we don't know !") but we are working on it and we hope we can still detect it. What makes you say it is impossible ? Have you already tried this kind of analysis ? Or have is it just that the O2 drop is not significant enough to be distinguished from normal ups and downs ?

Ha and I notice you are from Canada, I think that people from the US would benefit a bit more depending on their insurance as it is not always completely reimbursed.

We also want to work on the fact that we can give the device and provide a diagnosis very fast. How long did it take for you ?
I agree that the at-home tests are now rather simple but I think some people still find them uncomfortable (the nasal cannula must not be very pleasant to wear), what do you think ?

With UARS, there isn't the same drop in oxygenation....the body is responding too quickly to the events (unlike in full-on obstructive events where there can be a significant drop in sats). The Level 3 studies catch them with the changes in breathing rate and the corresponding changes in oxygenation. Going by pure oximetry, they probably wouldn't be significant enough to pick out from background noise.

The Level 3 "get-up" isn't the world's most comfortable (at least initially), but it does give pretty definitive results. In my case, it was a fax request to my GP to fill out/sign off the testing requisition, one night with the recorder and a couple days to get the data reviewed by a sleep doc.

If you're aiming for a US market and you can get an algorithm that is effective, then sure, I can see it being an alternative, especially if it is cheap and fast. I know in the US the fax referral for the Level 3 study would cost a few bucks with the Dr.'s office. I don't know if the DME's down there work differently....but they provided the equipment free of charge (after all, they want your business). In the US, the Sleep Doc review of the data would probably cost you too.

Pierre, it may be a somewhat limited market, but it is a good sized limited market. I wish you luck if you press forward

[retired_guy]

retired_guy, for you what we lack (compared to fitbit) is that we wouldn't be of enough use for you is that it ? Whereas if it is on Fitbit you already have a platform you use so it would be like an upgrade, am I right ?

I'm just thinking if this was my box, how could I best get a bunch of them out there and make some money while I'm at it.

For the medical community I feel it's too inexpensive to impress, it is too simple to use to impress, and it gives too much control to the patient versus a nice, in-house sleep study. So again if it's my box, I figure I might sell a few to a few more "enlightened" docs and clinics, but probably not enough to keep gas in the Volkswagen for all that long.

On the other hand, zillions of people are now wearing a bracelet of some type to keep track of their daily activities. Even me. My wife wears one and regularly logs 6 miles/day. Me? I log maybe 1 mile per day. But it does encourage me to try to do better, which given the fact that my emphysema tries to keep me from doing anything, a little encouragement is important. So add to that apnea, and I'm a target for any cute little device coming down the pike.

One of the sales gimics on my Fitbit is that it will "track" your sleep. What that amounts to is you start the timer when you go to bed, and you turn it off when you get up. That's about it. So if you actually interfaced your product with them, so that their bracelet not only tracked how long you sleep, but also reported the O2 sats and whatever else you can do, that would be an attractive addition to their offering, which could translate to attractive appearances of your bank account.

[archangle]

Isn't it true that a considerable fraction of the people who test positive for apnea in in-lab PSG tests never show O2 desats? Even among those who are classified as severe apnea? They don't suffer the effects of hypoxia, but they do suffer from disturbed sleep, stress, etc.

I'd be worried that such a device would misdiagnose these apnea sufferers and cause them to not get appropriate treatment because "I had a test and it didn't show apnea."

Or have you figured out some way to detect these "non-desaturation" apneacs from pulseox readings?

Is this just a different way of marketing and providing the same overnight pulseox test that has been used for some years.

[pierre.gilfriche]

PsychoMike :
The question of UARS is very interesting, we haven't worked on it yet but this is something we will definitely have to take into account at one point.
Concerning the fact that we would have to pay something for a sleep doc to analyze the results I totally agree, this is something we are trying to figure out right now. There are several options for the analysis (having several doctors we know that we would pay for each analysis, leave the patient go and see a doctor with the results of his analysis for the doctor to take conclusions etc.)

retired_mike :
I see what you mean, that would be an intersting development. Right now we are more pushing to go on the medical field rather than on the fitness field, but the more I think about it, the more I think we shoulde explore this possibility. The easy way would be to propose both options : the device can be used for screening, so for medical purpose to conclude on "sleep apnea" or no "sleep apnea", and for "fitness" purpose (or rather "personal monitoring in the long term"). The problem is that both options are pretty different and it would completely change the way the device is seen (if considered more like a fitness add-on, the medical community wouldn't take it seriously, and if considered as a medical device, it's a bit scary for fitness use). But I agree with you that it would be an interesting development for us, we will try to be a bit more medical-oriented in a first time, but once we grow a bit I think we will knock on Nike's door =)

archangle :
We have led a survey on people suffering from sleep apnoea and actually O2 desats are a good indicator. That was the topic of the thesis of a member of our team (published at the end of this year) and the study have been conducted on approximately 500 people, showing good results (I don't have the exact datas but I can send you her name by message if you are interested in reading the thesis when published). I agree that there are people for whom we won't be able to conclude on a diagnosis, but we will be careful and in case of any doubt the result won't be "you don't have sleep apnea" but rather "we can't conclude on that, you should have a PSG"
In the principle, it is the same as other overnight pulseox as it uses the same signal : the most important difference is that most other systems not only use a pulseox but other channels (airflow, breathinh effort) that make the system rather complicated to wear for some people. We aim at having the same precision but with only the pulseox, and we also want to work on the interaction with an app to have direct analysis and a primary feedback, as well as online analysis of the result for long term monitoring (if you want to check if your cpap is effective for example, or you want to control how your condition changes with time).

[Mac_Sheepcounter]

Pierre,

after i noticed the horrible cost for the sleep-apnea prediagnostic devices on the market, i spent the last two months thinking about a cheap and useful solution. So let me throw my 2 cents into the discussion:

Monitoring just the SpO2 won't help you much. If it would be that easy, you could take a relatively cheap and good device like the PO-300 here:
[DME link removed per Apnea Board rules]
(Sorry for the german hit, but it was the first good one i found)

But SpO2 alone is a pretty useless parameter. Maybe your wife is just pressing a pillow on your head?

You need a bit more information:
- Your sleep position (left, right, on the back...)
- Some microphone to measure snoring
- Some REAL idea about the breathing (there are some cheap and simple solutions around)

Only if you collect all these data: SpO2, snore, position and breath, you're able to translate this into some idea of the sleep process.
A lot of patients will have apneas only, in "sleeping at the back" position (tongue may block the airflow in this case).
Also the snore is an indicator for the sleep quality. This depends also heavily on the sleeping position.

If you're seriously planning to build a useful device, send me a PM and let's get in touch :-)

Mac

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[Dburg1947]

I like the idea as a screening tool that is easy to use. You have some selling to do to convince people of the statistical correlation between the O levels and sleep apnea. Can you detect stop breathing events?

You have the two strongest most powerful Unions in America that will not be on your side. American Medical Association and American Bar Association.

Tie in with Docs ans Clinicians in India and CostaRica . Let them diagnose sell machines on line and do remote diagnostics on line and you may have a winner. I would be interested in helping setting up the Costa Rica business model.

Regards. Dennis retired Engineer