Later this month, I will return to Sao Paulo for the 7th International Symposium on Snoring and Sleep Apnea. It has been a true pleasure to join colleagues and share our experiences as well as the latest research. Brazil is home to some of the world’s premier sleep researchers, including Dr. Geraldo Lorenzi-Filho (shown here in a rare moment when he is not smiling) of the Heart Institute (InCor) of the University of Sao Paulo. Dr. Lorenzi-Filho is one of the coauthors on an article in this month’s issue of the journal SLEEP.
The article described the formation of INCOSACT, the International Collaboration of Sleep Apnea Cardiovascular Trialists. The article points out the solid evidence showing that sleep apnea, particularly severe obstructive sleep apnea, is associated with substantial cardiovascular disease, whether an increased risk of developing hypertension, heart attack, or stroke. They also point out that the evidence does not show as clearly that treatment of sleep apnea reduces these risks. The mission of INCOSACT is to develop “multicenter international clinical trials of sleep apnea treatment, with a particular focus on studies to reduce sleep apnea-related cardiovascular risk.”
These international trials will be more expensive but more applicable to patients around the world
INCOSACT and its mission are bolder than they seem, as the article points out many of the challenges of performing these studies: the need for these studies to be very large (and expensive) and the ethics of withholding treatment (assuming these trials will compare positive airway pressure therapy to placebo) from some patients with sleep apnea. INCOSACT will have their work cut out for them, but their goal is not impossible. The authors correctly point out that there are a number of the kind of studies they would like to see, generally supported by governmental bodies because of their substantial costs. However, INCOSACT is proposing much larger studies, leading to a need for international cooperation. Of course, international studies have another important attribute, called generalizability; because the studies includes participants from a number of diverse groups, the conclusions may apply more broadly to populations around the world.
Can we do the same thing in sleep apnea surgery? Yes but…
A number of people have called for similar international efforts for sleep surgery. Whether this would proceed under the auspices of INCOSACT or another group is not clear, although INCOSACT appears to be focused on nonsurgical treatment. Based on my own extensive discussions with experienced clinical researchers (surgeons and non-surgeons), I know the challenges for surgical studies (with placebo controls) are more imposing than people typically imagine. Without going into exhaustive detail, a number of surgical studies (not limited to sleep apnea surgery) have shown that patients, once they are considering surgery, are less willing to accept randomization to a placebo group, whether it is no treatment, waiting, or something similar. I have been fortunate to work with companies that have proposed or conducted sleep surgery randomized trials supported by outside companies, so it is possible. Unfortunately, I have not seen the willingness of the National Institutes of Health or other group in the United States to support sleep surgery research to the extent that would be necessary to fund large, placebo-controlled trial outside of industry-supported efforts.
I applaud those who are dedicating time and effort to INCOSACT, as they will contribute greatly to our understanding of sleep apnea treatment. At some point, sleep surgery will be ready to follow this example, and I look forward to that day.