US-based medical device company Advanced Brain Monitoring has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Night Shift, a therapy for positional obstructive sleep apnea.
The Night Shift is a clinically proven solution for patients with positional obstructive sleep apnea and snorers. Night Shift, an intelligent and interactive monitor, allows users to track its affect on snoring and sleep quality.
Night Shift, which is worn on the back of the neck, begins to vibrate when users begin to sleep on their back and slowly increases in intensity until a position change occurs.
According to Advanced Brain Monitoring, clinical study data demonstrated that 89% of participants responded to Night Shift therapy, with the majority experiencing improved sleep quality, reduced loud snoring and improvements in sleep apnea symptoms.
Principal investigator for the study Daniel Levendowski said that in the clinical study, they found that 70% of individuals with obstructive sleep apnea are at least twice as severe while sleeping on their back and may benefit from Night Shift therapy.
Advanced Brain Monitoring’s Night Shift is immediately available through an Indiegogo crowdfunding campaign until 22 June 2014.