The story presents one glowing personal anecdote about the new devices but no sense of how much research has been done to date. It doesn’t discuss costs or spend enough time with independent experts. Because it selectively chooses the scariest facts about sleep apnea, it veers into disease-mongering, helping to hype these new devices without giving enough data about benefits from current approaches.
Sleep apnea is a real problem for a minority of people. Usually it is a warning sign of another, even more serious problem: obesity. One of the unseen adverse effects of obesity is the development of sleep apnea. At the moment, about 12 million Americans have diagnosed sleep apnea. That number is expected to increase along with the increasing problem of obesity. At the moment, the symptoms of sleep apnea can be successfully managed with the use of specialized breathing masks used at night. Unfortunately many people cannot tolerate the masks, since they are uncomfortable and are very confining. Other somewhat more drastic approaches including surgery have not been widely adopted. That’s why another approach to sleep apnea is of interest. The technology described has been under development since the early 1990s and described in previous studies. Treating sleep apnea with a medical device might be effective for some, but people who are obese need to address the root causes of their weight. That approach might, indeed, include a medical device, such as a lap band, but targeting each “side effect” of obesity with a different device would lead to a mind boggling escalation of costs, not to mention the potential risks involved in each surgery.
There is no mention of costs for the surgical implants or any of the other treatment methods. Whether insurers are likely to cover such treatments and whether they cover current treatment approaches would have been helpful information as well. The cost of medical devices needs to be considered for a host of reasons. A similar technology (vagal nerve stimulation) costs about $20,000 and could have been used as a useful example.
No data on benefits are given for the “undisputed best treatment, called CPAP. ”
Regarding the new devices, because they are in early studies, any suggestion of benefit must be made carefully. While a number of provisos were included in the story, the single patient anecdote and the “What we’re looking for is actually cure” quote from one of the investigators provide the reader with an imbalanced perspective.
There is no mention of potential harms. This is troubling because the devices described would require a surgery. To be eligible for one of the devices, a person would need to undergo some fairly extensive testing, much of which is rather unpleasant, including having “a tube snaked down the airway” to see whether their sleep apnea is being caused by a qualifying condition. The device is surgically implanted in the chest with wires run up the neck and into the base of the tongue. Once implanted the device now needs to be programmed to deliver the stimulation at the right time. There is a potential for nerve damage with long term use and the devices (as we have learned from the recent recall of heart defibrillator leads) are not infallible.
There is no attempt to evaluate the quality of the evidence. We are given one anecdote of a man presumably enrolled in a clinical trial, but we don’t learn how much research has been done – only that a “key study” of 100 people is planned. There is also no evaluation of the evidence for “today’s undisputed best treatment, called CPAP” – only estimates of how many people won’t or can’t use it.
This lead made us stop in our tracks. “Loud snoring may do more than irritate your spouse: It can signal sleep apnea, depriving you of enough zzzz’s to trigger a car crash, even a heart attack.” Car crashes and heart attacks? This sounds like a national emergency. The story goes on to say, “More than 12 million Americans have obstructive sleep apnea, according to the National Institutes of Health….Yet going untreated is more dangerous than just feeling tired. Sleep apnea stresses the body in ways that increase the risk of high blood pressure, heart attack, stroke and diabetes. More immediately, severe apnea increases the chance of a car crash sevenfold. Last year, the National Transportation Safety Board recommended that pilots, truck drivers and other commercial transportation operators start being screened for apnea, saying it has been a factor in incidents involving every mode of transit.” How many incidents? Is sleep apnea more dangerous than, say, texting while driving? Without any context, these facts serve only to scare, not to inform.
There are many quotes in this story but none comes from an independent source. Meir Kryger, a sleep medicine specialist at Gaylord Hospital in Connecticut, is the most quoted and is receiving money from Inspire Medical Systems, a device maker, for clinical trials. Rik Krohn, a 67-year-old from suburban Minneapolis (where the company is based – how was he chosen?) is quoted as a sleep apnea sufferer who may have been helped by the Inspire device. We’re not told what connection Dr. Rick Odland, Krohn’s surgeon at Minneapolis’ Hennepin County Medical Center, may have with the company. He is the co-founder of his own medical device company, Twin Star.
There is apparently one independent perspective – a voice of caution relegated to the very end in a two sentence paraphrase. “These experiments are only now beginning, with a handful of implants performed so far—and while it’s an interesting concept, frustrated patients should try some proven steps first, cautions, Dr. Amy Atkeson of Columbia University Medical Center in New York. Her advice: Don’t give up on CPAP without first seeing an experienced sleep technician to adjust humidity levels and take other steps that not every CPAP prescriber knows to try—and if you’re overweight or obese, apnea greatly improves with weight loss.”
The imbalance in the quotes provided, and the absence of any conflict of interest disclosure leads us to give an unsatisfactory score.
The story does not do an adequate job comparing these devices to other treatments or to weight loss.
The story ends with this brief statement: “Don’t give up on CPAP without first seeing an experienced sleep technician to adjust humidity levels and take other steps that not every CPAP prescriber knows to try—and if you’re overweight or obese, apnea greatly improves with weight loss.”
But, as noted, no data is given on CPAP’s benefits – only discussion of what doesn’t work with CPAP. And no data were given – only this one line – about the role of overweight, obesity, and weight loss in sleep apnea.
The story provides a very good overview of the ongoing trials of the various companies’ devices and notes an upcoming clinical trial.
The story makes it clear that there are several devices in competition to be the dominant sleep apnea device. “By the end of January, Minneapolis-based Inspire Medical Systems plans to begin enrolling 100 apnea patients in a key study in the U.S. and Europe to see if so-called hypoglossal nerve stimulation really could work. Two competitors are developing similar implants: ImThera Medical of San Diego says it hopes to begin U.S. studies later next year, and Apnex Medical of St. Paul, Minn., has announced some small-scale testing.”
The story does not rely on a news release.