improve or lead to major breakthroughs. Completely new therapies that were either recently released or are in active clinical trials are as follows:
Provent: This device is disposable and consists of a valve placed over each nostril with low inspiratory resistance, but quite high expiratory resistance (50 cm H20). This leads to increased lung volume and high positive airway pressure during expiration (thereby dilating the airway), which probably explains its efficacy (about 50-60%). This therapy has been available for several years now, but has never gotten serious traction. This is probably a product of both its somewhat limited effectiveness and the discomfort many patients complain of when using it. Thus Provent will not likely ever be broadly utilized.
Genioglossal Stimulation (Inspire): There were several companies developing devices to stimulate the genioglossus muscle to keep the pharyngeal airway open during sleep. One (Apnex) recently went out of business due to a failed clinical trial. The most evident remaining company is Inspire, which is near completion of its FDA trial. Their device stimulates the genioglossus muscle unilaterally and is phased to inspiration using a pressure sensor placed between the intercostal muscles. Of note, their current clinical trial does not include morbidly obese patients and requires a sleep endoscopy (airway visualization under anesthesia) prior to the procedure to be sure that the site/level of collapse is suitable for this therapeutic approach. I will speculate, as the data from the trial have not been publicized, that this therapy will work well in some patients and will be acceptable to a reasonable percentage of OSA patients. However, it is quite expensive with the stimulator itself costing $15-20,000 with this price not including the sleep endoscopy, the surgical procedure, or the follow up care (including sleep studies). Thus, all in, this approach will likely cost $30-40,000 per patient. As a result, insurance companies will likely limit access to this procedure and it will thus never be widely used to replace CPAP in the millions of new patients receiving CPAP annually.
Winx (Apnicure): The Winx device consists of a console that generates negative pressure and