Our Review Summary
In a small study published in The Lancet, a nerve-stimulating pacemaker was surgically implanted in patients already suffering from central sleep apnea. The 151 patients were randomly assigned to either an activated device (68) or to a control group (73) whose device remained inactive. After six months, a little more than half (51%) of the group receiving the active neuro-stimulator device showed their apnea events per night cut in half or more, compared to 11% of the control group with the inactive implant.
The release provided a good discussion of the benefits, and used absolute numbers to quantify them. The principal investigator is a consultant for the device company that paid for the research, which the release disclosed in an end note. The release could have provided more context on how the device might impact future quality of life, and where the neuro-stimulator is placed. One might imagine it is in the brain rather than in the chest pectoral region which is the case here.
Why This Matters
Central sleep apnea (CSA) occurs when the brain fails to signal sleep properly. It is less common than obstructive sleep apnea (OSA) which results in disrupted breathing during sleep because of upper airway obstruction.
It isn’t easy to try to estimate how many Americans have CSA. The release notes that “CSA is a serious concern because it affects about a third of people with heart failure and it’s known to make the condition worse.” The rate of CSA referenced in the published study is 0.9% or 9 out of 1,000. Another recent study estimated that 9 percent of a group of 5,000 patients in a sleep and heart health program had CSA.
Criteria
Not Satisfactory
There was no mention of cost. Surgery to implant a device is likely to be quite costly and it will require maintenance.
Satisfactory
We were glad to see absolute numbers and not just percentages used to quantify the benefits of the study.
“At the six month evaluation, the device reduced CSA events per hour by half or more for 35 of the 68 members (51 percent) of the treatment group. Only eight (11 percent) of those in the control group achieved the same reduction.”
A bit more discussion on how the device might impact future quality of life or how long the benefit might be sustained — provided the data was available — would have been useful context.
Not Satisfactory
The release contains this short phrase “without causing serious side effects” in reference to potential harms. We find that inadequate considering that CSA is serious condition that occurs in already very ill people. Presumably, they would be susceptible to a range of risks for side effects from the surgical placement of the device.
The release also states that 10 study enrollees were “excluded due to non-study related medical issues or deaths, exiting the study or missing visits,” and “About a third of patients in the treatment group reported therapy-related discomfort that was resolved with some reprogramming of the device.”
We think a discussion on why some patients exited the study (was it due to intolerance?) and some details on “therapy-related discomfort” were warranted here.
Satisfactory
We rate this as marginally satisfactory. Overall, the release contains enough information for readers to judge the quality of the evidence. It includes information about the randomized trial and number of patients in both the control and experimental groups, as well as the duration.
Most of the outcomes had objective measures — and that’s to the good — but important patient-relevant outcomes like congestive heart failure, high blood pressure, cardiovascular event rates, etc., were not studied. The release could have mentioned that this was a limitation of the research.
Satisfactory
There was no disease mongering.
Satisfactory
The release meets this standard with an end note stating that the study was funded by the manufacturer of the device, and that the quoted researcher is a consultant to the manufacturer.
We are glad to see news releases beginning to incorporate more transparency and addressing conflicts of interest.
Satisfactory
We give this a borderline satisfactory rating. The release gives brief mention to a common treatment for sleep apnea — continuous “positive airway pressure,” or CPAP devices — but it provides little context other than to say “many patients don’t tolerate them well and a recent study showed them to be harmful.”
The release could have included more context to help a reader evaluate the traditional treatment compared to the surgical implant, or weigh risks vs. benefits of having the implant.
Not Satisfactory
The implant was made available to patient volunteers through a clinical trial, and that’s an implication to savvy readers that the device isn’t available to the general public. But there’s no clear indication of whether the device is on the market or not. The news release should have stated that it is not generally available and it is unknown if major payers will cover it if it ever comes into wider use.
Not Satisfactory
The release does not make any claim of novelty, and that’s unfortunate. The published study did note that the trial was the first of its kind, to the best of knowledge of the researchers. But readers who don’t go beyond the release won’t be privy to this.
Satisfactory
We did not find unjustifiable language.
Total Score: 6 of 10 Satisfactory
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