CLEVELAND, Ohio — Every remedy for sleep apnea has a downside.
CPAP machines have clunky masks, they’re a hassle to travel with and as romantic as a cold sore.
Mouth appliances can cause jaw pain and drooling.
And who wants surgery? Especially when there’s no guarantee it will work.
That has left thousands of patients with apnea — a disorder that causes them to stop breathing periodically while they sleep — tired and frustrated.
So imagine their excitement when a doctor came up with a device that treats sleep apnea, avoids those problems and is so small you can tuck it into your wallet.
“It’s the biggest advancement in the treatment of sleep apnea and snoring in over 25 years,” says Dr. Joseph Golish, a doctor at the NorthCoast Clinical Trials Sleep Center in Beachwood and MetroHealth Medical Center in Cleveland. “It’s a real game changer.”
Golish and other sleep-medicine experts are quick to warn that the new device, called Provent, has drawbacks as well.
“It’s a new tool, but it’s not going to be for everybody,” says Dr. Dennis Auckley, director of the Center for Sleep Medicine at MetroHealth. “The role it plays in the treatment of sleep apnea is going to be evolving as we learn more about it.”
Provent, which is available only by prescription, looks like two small, circular Band-Aids, each with a tiny clear plastic valve in its center. To use the product, you place one of the hypoallergenic, adhesive ovals over each nostril and go to sleep. In the morning, you take them off, throw them away and start with a new set that night.
The technology is simple.
The valves open when you inhale and partially close when you exhale. That builds pressure in the airway, which opens the back of your throat.
The closing of the back of the throat is what causes obstructive sleep apnea, the most common form of the disorder, and the snoring that comes with it.
For more than 25 years, the go-to treatment has been CPAP, short for Continuous Positive Airway Pressure, a machine that blows air into a person’s nose — sometimes the mouth, too — forcefully enough to keep the back of the throat open.
The air comes from a bedside device that weighs about 2 pounds, and has an air hose and a mask.
While CPAP machines have gotten smaller, quieter and more sophisticated over the years, about 50 percent of patients who need them can’t or won’t use them, Golish says — for all kinds of reasons.
The mask can be claustrophobic, get in the way of glasses and fall off at night. The humidifier that snaps on to most of them and is designed to keep your nose and throat from drying out, can be too wet or too dry. The tubing can prevent you from sleeping on your stomach or rolling over.
That’s why a lot of CPAP machines, Golish says, end up as doorstops.
And it’s why some patients switch to one of several mouth appliances that move the jaw or tongue forward, open the throat and allow more air into the lungs.
Other patients resort to surgery or over-the-counter or home remedies.
“There are so many treatments because there’s still no single good one that works for everyone,” says Golish, who began prescribing Provent about six months ago.
He tends to recommend the disposable product to patients with mild to moderate apnea, he says, because it doesn’t eliminate the number of times a person stops breathing, it reduces them.
“And CPAP,” he says, “pretty nearly eliminates them.”
Still, Golish considers Provent a good solution for those with serious apnea who can’t — or won’t — use CPAP or who want something that’s easy to carry onto a plane or slip into a backpack.
Provent was invented by Rajiv Doshi, a doctor who has taught medical-device design at Stanford University, holds a dozen patents and has more than 20 others pending. He began work on the idea at his dining room table in 2004, to try to stop his own snoring. It was keeping his wife up at night.
It took him a year to completely stop the annoying noise. Another year later, he began studying others as they used the invention he calls EPAP. That’s short for Expiratory (to breath out) Positive Airway Pressure.
The U.S. Food and Drug Administration approved Provent in 2008. And serious marketing began last year, after results on how effective it is were published in the Journal of Clinical Sleep Medicine and another peer-reviewed publication called Sleep.
“I’m very proud of the rigorous clinical studies that we ran to demonstrate the effectiveness of the product,” Doshi says. “The studies showed that the product really works.”
But Auckley points out that the number of people studied has been small, patients who didn’t want to continue using Provent were dropped from some of the research, and more work is necessary to truly understand how well Provent works.
In addition, it’s not recommended for anyone with severe respiratory or heart problems, and it can take up to a week to get used to.
On top of that, cost can be an issue.
Provent costs $ 120 for a 30-day supply. That’s $ 1,440 a year.
A CPAP machine with mask, hose and humidifier typically costs about $ 1,500, Golish says. While the mask and hose have to be replaced periodically, patients can use the machine for years. And it’s typically covered by insurance.
Because Provent is new, it isn’t always covered, but more and more insurers are paying for it, too, Golish says.
Still, some patients say it’s the perfect solution.
“The snoring immediately stopped the first night,” says Carol Lennon, a Jefferson woman who has been using Provent since Dec. 14. “My boyfriend’s very happy.”
Lennon, 53, was diagnosed with moderate sleep apnea in November and told she needed a CPAP.
“I said ‘I’m not going to use that. They’re ugly, they’re obstructive, and I know so many people that have them and do not use them.’ “
She searched online for alternatives, found Golish and drove more than an hour to see him at his Beachwood office.
A follow-up sleep study shows her apnea is now minimal, which means she stops breathing five or fewer times an hour — nearly normal, Golish says — as opposed to 15 to 30 times an hour before.
“For somebody that can’t sleep, it’s worth it,” Lennon says. “The only downside, I would say, is they’re really only a one-time-use product.”
That and the cost if her health insurance refuses to pick up the tab.
If that happens, Lennon says she won’t give it up.
“I’d figure a way to pay for it,” she says. “Right now it’s my only alternative.”