It’s essentially what we call a target trial emulation or TTE. It uses data from 31 million people, about 40,000 people who recently started for sleep apnea treatment. What we do is sort of a back to the future kind of study where we go back in time and then we match people based on what treatment they get whether they get CPAP or whether they get hypoglossal nerve stimulation or if they have no treatment...
It’s essentially what we call a target trial emulation or TTE. It uses data from 31 million people, about 40,000 people who recently started for sleep apnea treatment. What we do is sort of a back to the future kind of study where we go back in time and then we match people based on what treatment they get whether they get CPAP or whether they get hypoglossal nerve stimulation or if they have no treatment. And we match them by their age, sex, body mass inde,x and all the other covariates like existing cardiovascular disease and follow them forward. Now, the reason why we did that was because the problem with doing regular clinical trials is that patients who are sleepy or who have very severe sleep apnea cannot be randomized to get no treatment and for us to wait to see if they have heart attacks and strokes. And that would be unethical. But those may be the very same people with very severe disease who are most likely to suffer those consequences that are seen in observational studies. So we call this a real-world study where these are real-world patients, but we use the data to simulate a trial by going back in time and then coming forward to this point in time to see what are the differences in major cardiovascular events in people with obstructive sleep apnea when they get hypoglossal nerve stimulation or CPAP or no treatment. And when we did that, we found that hypoglossal nerve stimulation was better than no treatment in reducing eight out of nine cardiovascular events. CPAP was better than no treatment for six out of nine cardiovascular events. But hypoglossal nerve stimulation was better than CPAP for four out of the nine cardiovascular events. In other words, it’s saying head-to-head, the hypoglossal nerve stimulation may be superior to CPAP therapy on that basis.
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