SomnaPatch, a new skin-adhesive diagnostic patch, provided significant clinical value for the detection of sleep apnea across all severity levels, compared with standard in-lab polysomnography, according to data presented at SLEEP 2017.
“Portable home sleep monitors are being increasingly utilized in clinical practice for diagnosing sleep apnea,” Maria Merchant, PhD, CEO of Somnarus Inc, and colleagues wrote. “However, most type III home monitors are difficult for patients to set up and wearing the monitors is disruptive to patient’s typical sleep pattern.”
SomnaPatch may be an effective alternative to these other home monitors, and Merchant and colleagues evaluated its diagnostic value. According to Merchant and colleagues, SomnaPatch will only minimally affect sleep and is inexpensive, easy to use, light-weight, disposable and flexible. The patch, weighing less than 1 ounce, records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position.
The researchers collected simultaneous polysomnography (PSG) and diagnostic patch recordings from 174 participants (mean age, 54 years; 55% male). They found that area under the curve was more than 0.9 for all six receiver operating characteristic curves (5, 10, 15, 20, 25 and 30 events per hour). The optimal threshold of apnea-hypopnea index (AHI) ≥ 15 was 0.86 for sensitivity, 0.83 for specificity and 0.85 for accuracy. The researchers performed Bland-Altman analysis which revealed that there was a bias of 0.9 events per hour and the limits of agreement were 18.1 and –16.1. The rate of clinical agreement was 85% between recordings with PSG AHI ≥ 30 and patch AHI ≥ 30, while the rate of clinical agreement was 89% between recordings with PSG AHI< 30 and the patch AHI within (PSG AHI ±10). Overall, the rate of clinical agreement was 87.4% (95% CI, 81.4-91.9).
“Our study provided clinical validation of a new wearable device for diagnosing sleep apnea,” Merchant said in a related press release. “It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies.”
“Most home sleep diagnostic devices are difficult for patients to use and are disruptive to patient's sleep,” she added. “Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep.” – by Alaina Tedesco
Merchant M, et al. Abstract 0448. Presented at: SLEEP 2017, the Annual Meeting of the Associated Professional Sleep Societies; June 3-7; Boston.
Disclosure: The researchers report receiving support from NIH.