, and/or laboratory measures of calprotectin or other biomarkers. These approaches can be costly, involve delays, and can carry risks, Korzenik said.To determine how well a noninvasive device could perform, investigators enrolled 120 people with 105 continuing in the study long enough to be evaluable; 44 people whose Crohn's disease was in remission, 35 with active Crohn's disease, as well as 26 healthy controls. Among those with Crohn's disease, 83% were on biologic therapy.
The participants put the device — which resembles a closed laptop or a large Wi-Fi router — in their homes and were monitored for a mean 306 days. Participants wore an ankle bracelet the first 2 weeks of the study so the device could learn to distinguish them from others in the home. Data from the device were collected and transmitted securely to a cloud database without any interaction from the participant. Data included information on more than 25,000 nights of sleep, 200,000 hours of breathing signals, and 400,000 measurements of walking speed.
When investigators looked at sleep as a function of disease activity in the patient-reported surveys, they also found a significant difference between people in remission vs those with active disease. For example, people with active disease had a greater number of awakenings at night , less REM sleep at night , and less time in deep sleep compared with those in remission.
Use of a remote monitor, the comparison of validated vs conventional data, and the large dataset were among the strengths of the study. The single center design and exclusion of people with some comorbidities are potential limitations. Cross shared a couple of caveats."The one devil in the details is always going to be cost," he said. Also, it's unclear who will read and interpret all the data generated by the device among"providers who are already overwhelmed with the volume of information."
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