Pete Celano, 1 September 2017
See previous Adhesive Sensor posts at www.mi2.org.
Credit: Somnarus, Inc.
In June of this year results of a 174 patient clinical trial were announced by Somnarus, Inc. regarding a new, disposable diagnostic patch and its ability to detect obstructive sleep apnea across all severity levels.
“Results show that the total rate of clinical agreement between the patch and standard in-lab polysomnography was 87.4% with 95% confidence interval of 81.4% to 91.9%. According to the authors, the study results will be used in obtaining approval from the U.S. Food and Drug Administration for the device, SomnaPatch. The skin-adhesive diagnostic patch weighs less than one ounce and records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position.”
Consider this August 2017 review; Obstructive Sleep Apnea (OSA) is highly prevalent–
“With this systematic review we aimed to determine the prevalence of obstructive sleep apnea (OSA) in adults in the general population and how it varied between population sub-groups. Twenty-four studies out of 3807 found by systematically searching PubMed and Embase databases were included in this review. Substantial methodological heterogeneity in population prevalence studies has caused a wide variation in the reported prevalence, which, in general, is high. At ≥5 events/h apnea-hypopnea index (AHI), the overall population prevalence ranged from 9% to 38% and was higher in men. It increased with increasing age and, in some elderly groups, was as high as 90% in men and 78% in women. At ≥15 events/h AHI, the prevalence in the general adult population ranged from 6% to 17%, being as high as 49% in the advanced ages. OSA prevalence was also greater in obese men and women. This systematic review of the overall body of evidence confirms that advancing age, male sex, and higher body-mass index increase OSA prevalence. The need to a) consider OSA as having a continuum in the general population and b) generate consensus on methodology and diagnostic threshold to define OSA so that the prevalence of OSA can be validly compared across regions and countries, and within age-/sex-specific subgroups, is highlighted.”
Current modes of measuring OSA, which in no way is the only sleep diagnosis, require spending a night at a sleep center (not your own bed) or home sleep testing with a veritable tangle of wires and sensors (your own bed but likely not your “true sleep”).
PREDICTED: Not only will hyper-convenient for the patient, patch-style devices wash over the OSA diagnosis space, but also they’ll prove highly relevant as a simple screener. Note: The use of a stick-on sensor for just screening typically does not require FDA clearance.
Next month: Adhesive sensors that deliver medications.