In order to detect sleep disorders data must be collected while you sleep. This typically requires the patient to stay overnight in a sleep center hooked up to several wires and sensors. Tests such as this are often enough to cause people to shy away from diagnosing their potential sleep disorder. These tests can last anywhere between one night and several nights. Many people find them disruptive to their schedule and routine. Thankfully, there’s now a new option on the market.
The Bethesda Center for Family and Cosmetic Dentistry specializes in treating patients who suffer from obstructive sleep apnea. Therefore, we stay up to date on all the latest technology when it comes to diagnosing and treating the condition. The new SomnaPatch is an innovative way to detect sleep disorders from the comfort of your own home. Treating sleep disorders such as OSA is very important to your health. If you think you might have a sleeping disorder, we recommend you get tested right away.
The SomnaPatch recently went through a clinical trial with flying colors. This disposable diagnostic patch is created by Somnarus Inc. It adheres directly to the skin and efficiently detects all levels of OSA. This innovative technology is comparable to traditional polysomnography diagnostic tests. The Sleep Review, the Journal for Sleep Specialists quotes the CEO:
“Our study provided clinical validation of a new wearable device for diagnosing sleep apnea,” says principal investigator Maria Merchant, PhD, CEO of Somnarus Inc, in a release. “It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies.”
Dr. Merchant was also quoted by Healio:
“Portable home sleep monitors are being increasingly utilized in clinical practice for diagnosing sleep apnea,” Maria Merchant 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.”
This device is incredibly easy to use. A related study of 39 home users proves the ease of use. Of these 39, 38 used the patch correctly to gather an appropriate amount of data to detect sleep disorders. They did this using the simple instructions that accompany the device.
Not only is it easy to use, but the SomnaPatch is also inexpensive, disposable, flexible, light-weight, and has very little effect on the patient’s sleep. Weighing in under an ounce, this incredible patch can record nasal pressure, heart rate, respiratory effort, blood oxygen saturation, sleep time, and even body position.
This incredible device is making waves in the sleep disorder field. It’s an incredibly accurate alternative to other home sleep monitors already on the market. It performs at the same level as traditional tests but can be done in the privacy and comfort of your own home.
The results from the clinical trials are being used to obtain US FDA approval. The Sleep Review and Healio go on to discuss the details of the trial:
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).
The researchers behind the trial are optimistic of the FDA approval. They’re eager to get it on the market so they can begin helping thousands of patients.
This patch is groundbreaking for detecting sleep disorders. It is believed that more patients will seek diagnosis and treatment with the option to test in their own home. This means thousands of people can begin treating their OSA and get on the path to recovery. It also goes hand in hand with the “unplugged” treatment options that many patients are choosing.
Patients are moving away from the traditional treatment of a CPAP machine. Instead, they’re opting to use dental appliances to treat their OSA. These dental appliances are custom designed to help keep the airway open and prevent sleep apnea episodes. Like many types of treatments, not everyone is a candidate. If you are diagnosed with a sleep disorder you want to make sure you check your eligibility for all treatment options. A quick consultation with our expertly trained staff can help you on the path to health and wellness.