A novel, disposable adhesive path can be used to detect obstructive sleep apnea, which is efficient at all severity levels, as per the results of a clinical trial.
Reports reveal that the total rate of clinical agreement between the diagnostic patch and standard in-lab polysomnography was 87.4 percent with 95 percent confidence interval of 81.4 percent to 91.9 percent. The study authors mentioned that, the results will be helpful in getting approval for the device SomnaPatch from the U.S. Food and Drug Administration.
What Is Sleep Apnea?
Sleep apnea is a condition wherein a person cannot breathe well during sleep because of obstruction in the airways during sleep by anatomical conditions or medical problems. This breathing condition can predispose one to have poor circulation particularly in the brain and other major organs, further leading to an increased risk for heart attacks, strokes and blood vessel problems. Thus early diagnosis should be done so that the problem can promptly be treated and further medical problems are prevented.
Efficacy Of Wearable Diagnostic Patch
The patch records blood oxygen saturation, nasal pressure, pulse rate, sleep time, respiratory effort and body position and it weighs less than one ounce and is skin-adhesive.
Principal investigator of the study Maria Merchant, PhD, CEO of Somnarus Inc, said that, our study offered clinical validation of a novel wearable device that could diagnose sleep apnea. It was amazing to us to see the performance of this inexpensive device when compared to in-lab sleep studies.
Real-time polysomnography and patch recordings from 174 participants were added in the analysis. Furthermore home usability study revealed that 38 out of 39 users were successful in activating the diagnostic patch and recording a minimum of 4 hours of sleep data while depending only on the instructions that comes with the device.
“Most home sleep diagnostic devices are difficult for patients to use and are disruptive to patient’s sleep,” said Merchant. “Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep.”
Merchant noted that, most of the home sleep diagnostic devices are not easy to use and are interrupting patient's sleep. This study demonstrated that wearable miniature device is very convenient, easy to use and does not disturb sleep.
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