Monthly Archive for January, 2010

More on the Zeo Personal Sleep Coach

Even though it has been over 6 months, my Zeo scam post is suddenly getting some comment traction. I thought I’d respond to some of these as well as clarify my thoughts.

I’m not really sure why Krunz thinks I’m an idiot.

First, I never said that changes in life style do not affect the quality of sleep. They do indeed. For example, for OSA (obstructive sleep apnea):

Some treatments involve lifestyle changes, such as avoiding alcohol and medications that relax the central nervous system (for example, sedatives and muscle relaxants), losing weight, and quitting smoking. Some people are helped by special pillows or devices that keep them from sleeping on their backs, or oral appliances to keep the airway open during sleep.

Second, I did say that because the ZQ score is based on sleep staging (no matter how crude), I can believe that an increased ZQ is indicative of better sleep.

My problem with the Zeo device is the claim that ZQ score improvement is caused by any particular life style change. This would be very difficult to validate.

Let’s say you recorded your ZQ score for 30 days without making any life style changes. There will be an inherent variability in the ZQ score that results from a variety of sources — electrode placement, user movement during sleep, etc.  Unless an introduced life style change can make a statistically significant change to the ZQ score you can not attribute causality to it. And even if there was a significant ZQ change you would still need to somehow prove that there were no other factors involved.

RobertF was not only more civil, but he took the time to detail his opinions and asked some good questions about mine. Here are my responses:

1. The red flag for me is when you make unvalidated claims. Anecdotal evidence of an improved ZQ score though “sleep coaching” is not validation.

The same is true for the “alarm clock” functionality. Zeo and others (e.g. Actigraphy) make similar claims about waking during lighter periods of sleep reducing sleep inertia.  Again, there is anecdotal evidence and even some testable theories, but a lot more research needs to be done in this area.

2. On one hand, Zeo does not claim that this is a therapeutic or a diagnostic device. From their web site:

The Zeo Personal Sleep Coach is neither a medical device nor a medical program and is not intended for the diagnosis or treatment of sleep disorders.

On the other hand they also say the Zeo provides:

…personalized sleep information and customized action steps to improve your Sleep Fitness™

Think about it. In one breath they say it isn’t, and then in the next they say it is!  It has nothing to do with FDA approval per se. It’s the contradictory claims that bother me.

3. I don’t think I was incredulous about this. I’ve mentioned several times that I think the dry sensor EEG technology probably provides enough signal quality to do a reasonable job of sleep staging.

4. It is the lack of “clinical validation” that is the most problematic for me. Basic sleep research may be heading in this direction — combining “sleep science, sleep education, neuroscience, behavioral psychology,…” — but they still have a long way to go.

5. Why would anybody that doesn’t have a sleep problem buy this product? If I did have sleep problems $350 would probably be well worth it, as long as it actually worked!  Sergey agrees.  If it didn’t work, I’d want my money back — and so would you.

6. You may not have any connection to the Zeo company, but the advisory board members are all paid to be there. I am not saying that this in any way lessens their scientific or professional credentials. On the contrary,  a good advisory board should be asking tough questions and doing their best to improve the product.

Wrap Up:

OK, I’ll admit it.  Maybe “scam” is too harsh. The reason I chose that term was because of its definition as a confidence trick:

an attempt to defraud a person or group by gaining their confidence

When I first read about the Zeo I felt that their presentation of the sleep science and technology was an attempt to gain a customer’s confidence. Beyond that there was little evidence that this product would help people.

I do not have any ill will towards Zeo. It appears that their customer service and return policies (30 day full refund) are good. As a medical device developer, I’m just pointing out what I think are important issues about this device.

I still maintain that the claims made by Zeo are misleading. You need to be able to show scientific evidence that the ZQ score actually does track with life style changes. Unless I’m missing something, Zeo has not done this.

Depth of Anesthesia Reality Check

I think this is the first time I’ve ever seen MedGadget express such a strong opinion about a technology.

Masimo Invests in Anesthesia Awareness Technology. Good Move? We Don’t Think So doesn’t pull any punches.

What’s interesting to me is that SEDLine was Hospira’s brain function monitoring business (see here).  Hospira bought the technology from a Boston-based company called Physiometrix in 2005.

Back in my EEG days I had a chance to work with Physiometrix. We interfaced with their EEG front-end hardware in an attempt to develop an OEM relationship.  At the time, they were using essentially the same Bispectral index (BIS) technology as Aspect Medical.  The only other thing I remember is that they were also using QNX.

MedGadget’s skepticism seems well founded. On the other hand, the people at Masimo (a couple of which I know) aren’t dummies . They may know something the rest of us don’t.

Ch-ch-ch-changes

About the only thing you can count on in this world, besides taxes and death, is change.

When we moved from Madison to San Diego in 2005, that was a big change. Of course in Jan/Feb the 70 deg temperature difference makes that decision seem pretty smart. When our 12 y/o golden retriever Miles passed away this past Oct. that change really sucked.

Switching jobs is also a big change.  As I’ve previously discussed, my old company was purchased and I chose not to relocate. As soon as wrote the words “in-the-trenches” I had an inkling that I had probably jinxed myself. Maybe jinxed isn’t the right word, but I certainly ended up in a different situation than I had imagined.

Last week I started working as a Health Informatics Architect at ResMed, a global leader in sleep medicine and non-invasive ventilation.  Like all medical device companies, ResMed is faced with the daunting challenge of providing the therapeutic data produced by their flow generators to physicians and healthcare organizations.

This position will allow me to continue to develop solutions for medical device interoperability, but at a whole new level. Working with a global team at a world-class company is a very exciting opportunity. I’m looking forward to the challenges ahead.

This change is good!

Actigraphy for Better Sleep?

I previously questioned the efficacy of the Zeo “Personal Sleep Coach” and concluded that this device would be unlikely to provide their claimed sleep improvements.

Another method for monitoring sleep patterns is with the use of Actigraphy*. I seriously doubt that these movement-based devices can do any better:

At least the Zeo device uses an EEG-based sleep histogram for determining sleep state. How can the acitigraph tell the difference between someone just laying awake quietly versus deep sleep?

*This Wikipedia entry reads like an advertisement for one these devices!

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