NYT runs press release for new OSA treatment Provent. Does it work?

Provent is the trade name for disposable, stick-on nose plugs made by Ventus Medical that are a relatively new (second-line) treatment for obstructive sleep apnea. The bandage-like device has pinholes cut in the nostrils that let air in during inspiration, but create back pressure during exhalation, helping prevent airway collapse.

The New York Times just ran a story on Provent in the Well blog that reads like a minimally-edited press release (the piece calls Provent a "godsend" for some patients, and closes with a patient describing Provent as "a miracle ... I'm just so happy I found it.") The fawning piece promptly hit #1 on NYT's "Most E-Mailed" list.

Does Provent work?

The randomized trial cited, published in April 2011 in Sleep, enrolled 250 people, almost all of whom had mild or moderate OSA (median apnea-hypopnea index of about 12). In about half of them, using Provent for 3 months resulted in a 40% or greater drop in AHI (from a median AHI of 14 to 6), compared to a drop of 10% with a sham device.

In a follow-up study at one year published in the Journal of Clinical Sleep Medicine, authors cherry-picked the 34 most-compliant patients who had had the greatest 3-month response to Provent. In this highly selected group (34 of the original 127), Provent resulted in a sustained improvement in median AHI, from 16 to 5.

Both studies were funded by Ventus Medical, partially conducted at private sleep centers, and all three authors report receiving financial payments from Ventus Medical.

There is no data on cardiovascular outcomes from the use of Provent. Only 18 Provent-treated patients had severe obstructive sleep apnea in the original cohort, according to Ventus Medical's website. Provent is not covered by insurance plans.

Clinical Takeaway: Provent could be a good option for people with mild or moderate OSA who are intolerant of CPAP or unwilling to wear it, who can afford the $75 / month out-of-pocket expense. At those prices, you can expect that only people who experience a benefit will continue to use Provent. People with severe OSA (defined as 30+ apneas or hypopneas per hour, or AHI) should be strongly encouraged to wear CPAP, since observational evidence suggests CPAP prevents cardiovascular events. Since so many people can't, won't or don't wear CPAP (and who can blame them?), Provent or devices like it certainly deserve further study in larger randomized trials.

Anahad O'Connor, "Treating Sleep Apnea Without the Mask," The New York Times April 9, 2012.