Compromised health affects Americans in countless ways, not the least of which is sleep deprivation. The price tag in lost productivity can hit a staggering $100 billion annually thanks to medical expenses, sick leave, and property damage. The National Highway Traffic Safety Administration estimates that more than 70,000 injuries each year are related to drowsy drivers.

There are many causes of sleep disruption, and patients rarely exhibit just one. Simply addressing sleep disordered breathing (SDB) may not result in good long term sleep. Other issues can range from an inferior mattress, a disruptive sleep environment, the wrong medication, pain, incorrect positive airway pressure (PAP), and insomnia.

As a result of these staggering numbers and the increasing awareness of sleep disorders, it’s reasonable that sleep should be one of the “vital signs” of health, together with temperature, blood pressure, respiration rate, pulse, pain, and BMI (body mass index).

Adequate sleep has been defined as regularly sleeping 6-8 hours per night. Clinicians now believe that sufficient slumber is a critical factor in health and health-related behaviors across all ages. It is not enough to simply spend these hours in bed. The quality of sleep is just as, if not more important than, the quantity.

Defining Quality Sleep
How is quality of sleep defined? For the sleep specialist, “good” sleep may be defined as sleep that has normal efficiency, organized sleep architecture, and the absence of any sleep dis- ruptions. For the patient, good sleep may mean waking up in the morning feeling refreshed and not feeling sleepy during the day.

How do we currently measure “good sleep?” One way is with an in-lab PSG test, which is often necessary but also expensive. A second way is through home sleep testing (HST), although most of these devices measure parameters that only detect sleep apnea. A third, purely subjective way we measure sleep, is to simply ask patients how they are sleeping. This last approach is akin to asking them whether they feel heavier or lighter instead of having them step on a scale.

In addition, if your patients have never slept well, how do they know they slept well last night versus sleeping a bit better than the night before? This leaves us with the sleep lab but how can we expect a patient to sleep “normally” and col- lect a representative night of sleep quality when there are so many cables and equipment attached to them, not to mention we are asking them to sleep in a strange environment – with a camera watching them all night – which takes us back to home sleep testing.

Cost Effective and Objective
All of this information points to the need for a simple and objective measure of sleep quality that is cost effective enough to use on patients regularly without being specific to a particular condition, in much the same way a scale will objectively measure weight. What’s needed is a “scale” that objectively measures sleep quality or sleep health.

Enter Robert Thomas, MD, and his colleagues at the Beth Israel Deaconess Medical Center, a teaching school of Harvard Medical School, who have taken a different approach to examining sleep—seeking to objectively measure sleep quality using cardiopulmonary coupling (CPC).

The principle behind this technology is the understanding that stable NREM (non-rapid eye movement) sleep is characterized by a cardiac rhythm known as sinus arrhythmia. During stable sleep, high vagal tone modulating a healthy heart results in characteristic heart rate variability in which the heart slows and speeds up in synchrony with very regular respiration. This is what Thomas calls stable sleep.

But not all heart rate variability is synchronized with normal respiration. Repetitive sleep disruptions, which could be caused by SDB, pain, a noisy sleeping environment, periodic limb movement syndrome (PLMS), restless legs syndrome (RLS), or anxiety, to name a few, can cause the heart rate and breathing rate to vary. This bradytachyarrhythmia is well recognized in polysomnograms.

These recurring disruptions can be seen as infrequently as once every 2 to 3 minutes, or as often as 1 to 3 times every minute, so they are difficult to see in a normal PSG test. How- ever, if we look at the data in terms of frequency we can see these changes occurring over sometimes long periods of time. It’s like being too close and not seeing the forest for the trees. This is unstable sleep.

Thomas also identified that there is little overlap between stable and unstable sleep, so they can be easily displayed and differentiated from each other. This makes interpretation much easier. The concept of stable and unstable sleep is central to CPC.

The result of Roberts’ CPC is a new, low cost, patient centered system call SleepImage that measures stable vs. unstable sleep. This test-anywhere device weighs less than an ounce, sits barely detectable on the patient’s chest, and also records actigraphy, body position, ECG, and snoring. It is fully integrated with a secure website and delivers a simple and easy-to-understand “picture of sleep” that identifies stable and unstable sleep to produce an objective measure of sleep quality.

There are many practical uses for the device, and because of its simplicity, researchers have been able to expand the identification and understanding of sleep beyond conventional sleep diagnostic practices. In the sleep lab, the CPC technology can be used to help identify complex sleep apnea, a disorder that may make conventional CPAPs intolerable for patients.

As a home sleep test, the SleepImage system can be used as a very low cost screener for patients that complain of poor sleep. The SleepImage will quickly and cost effectively validate whether an in-lab PSG or some other course of action is nec- essary and more importantly allow the physician to monitor sleep quality after intervention to ensure that the patient is complying with therapy or if there is another co-morbid condition that is continuing to cause poor sleep quality.

Perhaps the most noteworthy benefit of this technology is its ease of use, requiring little or no instruction to the patient, with automated analysis and easy-to-understand graphic results.

SleepImage is FDA cleared, and affords an objective measure of sleep quality that not only provides a picture of your patient’s sleep, but also assists in tracking sleep trends over time—offering an accurate measure of the effectiveness of a given therapeutic choice. So the next time you ask pa- tients how they slept last night, why not have an objective way to validate the answer?

For more information about SleepImage you can go to SleepImage.com

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The American Academy of Pediatrics (AAP) is revising its recommendations for the diagnosis and management of obstructive sleep apnea syndrome (OSAS) in children and adolescents, according to a clinical practice guideline published online in Pediatrics.

An updated clinical practice guideline from the American Academy of Pediatrics spells out which children with obstructive sleep apnea syndrome who undergo adenotonsillectomy should be admitted as inpatients.

Read Abstract Diagnosis and Management of Obstructive Sleep Apnea Syndrome

The first recommendation in the updated guideline advises clinicians to screen for OSAS during routine health maintenance visits, because OSA in children is underdiagnosed, stated Dr. Carole L. Marcus, Director Sleep Center at the Children’s Hospital of Philadelphia and chair of the subcommittee that assembled the guideline. Parents don’t necessarily think of snoring as a sign of a serious disease. They might think it’s funny, but it’s actually a sign of illness.

The guideline also recommends that the following subset of children be admitted as inpatients after tonsillectomy: those younger than age 3; those with severe OSAS on polysomnography; those with cardiac complications of OSAS; those with failure to thrive; those who are obese; and those with craniofacial anomalies, neuromuscular disorders, or a current respiratory infection.

Another component to the guideline is the recommendation that clinicians refer patients for continuous positive airway pressure (CPAP) management if OSAS signs and symptoms persist after adenotonsillectomy or if adenotonsillectomy is not performed.

To access full article Click Here

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Insufficient sleep is linked to more aggressive form of breast cancers and the likelihood of its recurrence, a study has revealed.The study, led by Cheryl Thompson, Assistant Professor at Case Western Reserve University School of Medicine, analyzed medical records and survey responses from 412 post-menopausal breast cancer patients with Oncotype DX.

The article titled “Association of sleep duration and breast cancer OncotypeDX recurrence score” is published in Breast Cancer Research and Treament. Click Here to read Abstract

Oncotype DX is a widely utilized test to guide treatment in early stage breast cancer by predicting likelihood of recurrence.

Researchers found that women who reported six hours or less of sleep per night on average before breast cancer diagnosis had increased Oncotype DX tumor recurrence scores.

“This is the first study to suggest that women who routinely sleep fewer hours may develop more aggressive breast cancers compared with women who sleep longer hours,” Dr. Thompson said.

“We found a strong correlation between fewer hours of sleep per night and worse recurrence scores, specifically in post-menopausal breast cancer patients.

This suggests that lack of sufficient sleep may cause more aggressive tumors, but more research will need to be done to verify this finding and understand the causes of this association,” she said.

The researchers also revealed that the correlation of sleep duration and recurrence score was strong in post-menopausal women. The data suggested that sleep might affect carcinogenic pathway(s) specifically involved in the development of post-menopausal breast cancer.

Source: University Hospitals Case Medical Center

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After more than three decades in the field of neurophysiology, engineers at Cadwell Laboratories are not shy about experimenting with new technologies. Collecting data in all its guises is still the main focus at the Washington-based company, and the willingness to innovate has led the company into the realm of digital video – gone mobile.

Specifically, the company has innovated a new mobile video recording solution they call Q-Video® Mobile.

As a neurophysiology-focused company, the developers at Cadwell believe the “next channel” for data collection— particularly video—is right around the corner. The concept may be ahead of its time, but Carlton Cadwell, president of Cadwell Laboratories, told Sleep Diagnosis & Therapy that they are more than willing to wait for clinicians and government officials to catch up to the idea. The following conversation took place at the 2012 SLEEP meeting.

Why are innovative monitoring solutions growing in importance?
Carlton Cadwell, president, Cadwell Laboratories, Kennewick, WA: Monitoring EEG on patients in a hospital is labor intensive. You literally must take care of a patient 24 hours a day, and it is often a financial burden on the hospital, and insurance companies pay a lot of money.

What are some of the real world problems that physicians are encountering and what can be done?
Physicians are having problems attracting technologists to their laboratories who can do 24-hour monitoring. The technologists are specialized and difficult to find. There is demand to monitor these patients, but these patients are leaving the areas to go elsewhere for the help they need..

We can deliver a solution to physicians that is much better for them and for their patients, and it financially makes sense for everyone involved.

Patients can come into a physician’s laboratory, on a Monday for example, and one technician can set up the patient in the laboratory, send the patient home with the device—with the patient wearing the device—and the patient can hold the Q-Video Mobile camera in his or her hand.

The camera is capturing digital video 100% of the time from the moment the patient leaves the laboratory until he comes back. This is the first time that we have ever been able to capture digital video and brain wave data, in transit, on these patients.

Are physicians responding to this concept?
Physicians are immediately starting to make the connection. They realize that when their patients have clinical events, the triggers are often outside of the hospital. Historically, physicians bring patients into the hospital and patients sit there and wait. Physicians look at them and hope they will have an event.

They are in a very sterile environment, and they may simply not have that event. It makes sense to have patients collect this data in transit, in the home, in the bus station, in the vehicle, or wherever they may be.

There may be a truck driver who says, “I just am not having any abnormal events while driving my vehicle.” The Q-Video Mobile device can now concurrently capture the video while the electrophysiological and brain wave data is being captured. We can conclusively prove that they either do, or do not, have a disorder. Sleep physicians at this meeting [Associated Professional Sleep Societies (APSS)] are now starting to understand what this means to them.

What are the other issues on the minds of sleep physicians as it relates to monitoring?
Reimbursement is a big issue right now, and it is something that all our physicians are running into. In the Pacific Northwest, we have insurance companies telling our customers that you can no longer bring patients into your laboratory if they have the classic symptoms of obstructive sleep apnea. You must do a home sleep testing recording in the home, identify the apnea, and if the patient has disordered breathing, you must treat him with an auto titration device.

What are the current limitations in monitoring equipment, and why is video so important?
When physicians look at just a few squiggly lines of data, the data is essentially flat, and the physician may see something in the wave form data, but they never truly understand what is happening with the patient.

They don’t know if the head is nodding, or if it is in an unusual position, which may be crowding or obstructing the airway. They don’t know if patients are falling asleep in a chair, and what is physically happening. Our new device allows physicians to capture that video along with the wave form data when the patient is in transit, when they are at home, or in their own bedrooms at night.

What is the situation regarding reimbursement?
One of the things physicians must do in the laboratories and the clinics is try to find out how they can use this technology in their laboratories—and get reimbursement. Today’s situation resembles what we saw with CPAP many years ago.

CPAP came out in the early 1980s, and we simply had a CPAP device that would blow pressure at one level. It opened up the airway, and we were all ecstatic because we could treat these people by blowing a lot of air.

The CPAP companies went out and got reimbursement. Ultimately, Bi-PAP came out and they were also able to go out and get reimbursement. We believe that advocacy for this type of reimbursement, for this type of recording, will lead to acceptance. The opportunity is there. It is a matter influencing the reimbursement community and our government. Government officials should look at video as a channel that should be reimbursed.

Home sleep testing recordings are being reimbursed all over the United States, and we are seeing doctors get between $180 to $225 as the typical range for home sleep testing recordings.

Are Doctors satisfied with the data they are getting?
What the doctors are telling us is that in their hearts they would like to capture more data in the home. They love the EEG, they love the raw QRS signal that we get from the heart, because it tells them the condition of the heart when they examine that wave form.

But the reality is that many of these devices must be dumbed down, for lack of a better description. They must be very simple devices that the patient can put on in their home. And so the types of channels that the physician is left with are fewer and more simplified. They must read between the lines to determine what is happening in the home.

Physicians are putting more pressure on manufacturers to extract more data from these devices. We are beginning to look at different signals to determine if there is more information in these simple channels that we are collecting. We do have end users who will capture these additional channels without getting reimbursement.

Frankly, they will be losing money when compared to their colleagues down the street. These colleagues are doing fewer channels, but billing for the same studies. This is what is happening in the market right now.

What are your predictions for the video aspect of monitoring?
I think video is the channel of the future. We tend to think of saturation as a definitive channel that identifies how severe our patients are, but when you are dealing with issues related to sleep, video will be a de facto channel. It does not matter where you collect the recording, but video must be collected to really truly see what’s happening.

Is this an opinion shared by your competitors?
I think Cadwell is the first to have a device that is truly mobile, where you can hold it in your hand and capture all audio and all video that is related to what is happening.

What are the technological challenges?
The key is synchronizing audio and video to the physiological data that you are collecting. If the doctor can look at both, and compare what they are seeing in the wave form data and the video—now they can conclusively make a diagnosis on these patients.

Your neurology clients are using your products, but what are some additional advantages for pulmonologists to switch to your products?
We build an open-ended platform that is capable of multi-modalities. These modalities cover everything from a simple type 3 recording, to a type 2 recording, to even a type 1 recording. These are the ranges of complex polysomnograms.

How about the EEG side?
On the EEG side, we have routine EEGs, 24-hour EEG, and 5-day EEGs. This one platform that we sell to a traditional sleep laboratory is capable of doing all these procedures. If we are looking at just the value of the Cadwell system to a hospital, you are simply going to get a better return on investment when you buy a system like ours.

For a hospital, that is wisely and carefully spending their dollars, the ability to use the device during the day for EEGs, and at night for polysomnograms, is something that is very desirable. We do see that many of the doctors that are stepping forward and talking to us at a meeting such as the APSS are neurologists who understand the value in using this equipment during the day and during the night.

There are other revenue streams. There are spike detection programs that allow physicians to bill additional fees for reimbursement. These are all things the market is looking for to ensure a healthy and sound laboratory.

What other products do you offer?
Our sister company, Cadwell Therapeutics, offers an oral appliance [The Silent Sleep] that really makes sense for patients. If patients come in to the laboratory and they are identified as having sleep disordered breathing, the patient may insist that they will not use a CPAP. At the end of the day, you’re putting a mask on my nose and blowing air in my nose. And you expect me to go to sleep?

When these patients fail CPAP, they need an option. So what Cadwell has done is something that allows the physician, in about a 15-minute period of time, to actually fit the patient with an oral appliance that has an FDA approval for snoring and disordered breathing.

If you are patient, and you have just failed CPAP after it may have taken you a year to get the courage to come into a laboratory to finally spend that night in the laboratory and identify this problem. This is a problem that has impacted your personal life, and your work performance in some cases.

Our oral appliance is so simple to set up that we can train the medical director how to fit a patient, and the patient could be fit that morning. The patient could be leaving the laboratory with something tangible, and some degree of hope, that perhaps this device may help them.

We can titrate them in the home with multiple oral appliances. We could set one device at end-to-end, and the next device at +2mm protrusion. The patient can take these home and can try the devices. Now when the patient comes back in several weeks and says device +2 works better for me, the laboratory does a titration recording on the patient in the home with this both oral appliances, and perhaps a third appliance at +4mm

Have sleep physicians responded to the oral appliances?
They can see the tangible benefit of this device.  The patient is telling them at 2 to 3 months out that he is a candidate for this device and ready to go to a custom long-term oral appliance.

That’s a real opportunity for success story and a happy patient. And the physician can get reimbursement for the Silent Sleep oral appliance. Everyone is happy and everyone wins.

Where do you see the sleep field in the future?
I see it going to multi-modality. Laboratories need to be smart and ensure that they are generating enough revenue to support their business.

There is so much in the industry that we can do, and there are things that are within reach that we are passionate about. We believe that we can do amazing things for our customers. This little Q-Video Mobile camera that I have discussed is a good example. This little device presents an all new development platform.

What are your plans on the software front?
The technology world is getting smaller, more powerful, and able to communicate in ways that were not possible just a few years ago. Software development is more and more graphically oriented and it is easier to intuitively understand what is happening to the patient. We are innovating ways that we can reach out to patients before they ever come into the laboratory for the first time. There are innovative ways we can follow up with the patient on a daily or hourly basis. We can bridge that gap for our customers.

How do customers view Cadwell Laboratories these days?
Customers are viewing Cadwell as a total solution provider. We are delivering solutions that touch every facet of what laboratories do. That is what we are excited about, and that is where we are heading.

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