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.
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.
There was no mention of cost. Surgery to implant a device is likely to be quite costly and it will require maintenance.
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.
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.
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.
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.
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.
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.
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.
We did not find unjustifiable language.
Systematic, Criteria-Driven
A lot of interesting workshops are happening now at the #NBCCSummit! @garyschwitzer, the publisher of @HealthNewsRevu, is discussing new cancer research news. #BeBold
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like