Necessity is the mother of invention, and when obstructive sleep apnea (OSA) sufferer Joseph Goldstein (left) of Pacific Palisades, Calif, found himself desperate for a way to make his continuous passive airway pressure (CPAP) treatments bearable, he turned to his well-honed imagination. The result was a device that eliminates the need for headgear and masks—the culprits responsible for many patients’ discomfort during treatment, including Goldstein’s.

“One morning I just started thinking about the problem, and I realized that there was only one part of the body that stayed in direct relationship to the nose. That was the upper part of the teeth,” he says. “So I took dental devices I had purchased and attached an extension above the lips. I could then use the extension to mount two parallel tubes that would go into the nostrils and convey the air.”

Genesis of the idea
Goldstein, who calls himself “a quasi-engineer businessman who should have gone to engineering school but ended up in marketing instead,” did not start his treatments looking to invent a new type of CPAP mask. Like most OSA patients, he simply began treatment with the intention of following his CPAP regimen faithfully.

“I couldn’t wait to get the CPAP machine and the mask,” says the inventor, who now holds about 35 patents for his creations, including an automatic machine for wrapping pallets in stretch film. “It was a novelty and I thought it would be lots of fun. I thought that I would now have a lot of energy from getting a good night’s rest.”

But as it does for many OSA patients, after a few days excitement turned to frustration. “For the first several nights, the experience was a piece of cake, but after a while the area around my nose became so irritated and my eyes hurt because of the leakage that I could not tolerate it,” he says. “I would take a couple of Advil and put Xylocaine around my nose to kill the pain until I fell asleep.”

OSA’s dangers
Stopping treatment and simply living with the lack of sleep and loud snoring associated with OSA were no solution. The lack of sleep that afflicts more than 12 million people in the United States with sleep apnea can diminish their quality of life, increase their risk of causing an automobile accident, and affect their job performance. In addition, research has linked OSA with coronary artery disease and stroke, although it is uncertain if OSA causes these conditions, or if they are all caused by a common problem, such as obesity.1

Goldstein first tried different masks to ease his discomfort. “Initially I started off with the rubber mask, and each time a new mask came out, I was first in line to buy it,” he says. “Every design that came out I bought, even to the extent that I started to buy dental devices with mandibular advancement. I bought one such dental device at the University of California Los Angeles. Then I traveled to Vancouver and paid $1,500 for another. Then I went to Dallas where I had a customized silicone mask made for $1,000. I really bought everything on the market in an effort to continue to use CPAP.”

Common Problem
Though Goldstein went to extraordinary lengths to continue treatment, his concerns were hardly unique. Many patients discontinue their CPAP treatment because of issues of discomfort with the headgear, which can shift during sleep and cause the mask to be forced in the opposite direction. This then leads to patients tightening the headgear to keep it in place, causing skin irritation and discomfort.

Last year, the Chest 2000 meeting of the American College of Chest Physicians presented findings about a group of 81 sleep apnea patients who had been questioned about their CPAP treatment compliance. In cases of noncompliance, the patients were asked to identify the factors that led to their discontinuing usage of the treatment. Mask discomfort was cited as the biggest issue for 33% of those patients in the elderly group and for 28% of those in the younger group.2

“These patients should be urged to try different CPAP delivery systems, with the emphasis on finding a comfortable one, with many seniors doing better on nasal pillows,” the Chest 2000 summary says.

When Goldstein could not find a comfortable mask, he invented one. His device uses a boil-and-bite mouthpiece or a mouthpiece custom-created by a dentist to keep the CPAP delivery tubes in direct alignment with the patient’s nostrils. The soft plastic nasal pillows maintain a comfortable fit within the nostrils, eliminating the need for a mask or headgear. The result, according to Goldstein, is greater patient comfort, reduced feelings of claustrophobia, and less facial irritation.

The device has undergone several studies at major sleep disorder centers around the country, and Goldstein’s CPAP device was introduced at the American Academy of Sleep Medicine meeting 2 years ago in Orlando, Fla. It was approved by the Food and Drug Administration a year later and went on the market in January 2001 as the CPAP Pro.

Positive Feedback
In addition to its intended use, Goldstein says the product has also generated interest for use in noninvasive ventilation. “I have gotten any number of favorable responses from patients,” says Goldstein, who initially had been selling the product on a direct basis to individuals. “Then a friend of a friend put me in touch with [a distributor] and that company realized the potential and benefits of this. Based on a handshake, we went forward with this project, which is now in exclusive distribution.”

Among the many positive responses the device has received so far, one stands out for Goldstein. “The physician at one sleep center in Ohio was so impressed that he called me in regard to another obese physician who required surgery for apnea, but with his weight could not tolerate it,” Goldstein says. “He requested one of my devices, and it worked extremely well for the physician and eliminated the need for surgery.”

For Goldstein, who plans on ending his inventing career with his CPAP device, the success of the invention has ensured his career will end on a high note. “This is my last hurrah—my last invention—and so far the results have been extraordinary,” he says.

Liz Finch is a contributing writer for Dealer/ Provider.

References
1. Obstructive Sleep Apnea. Sleep Channel: Your Sleep Community Web site. Available at: www.sleepdisorderchannel.com/osa/#comp. Accessed August 30, 2001.
2. CPAP Research Summaries from CHEST 2000: Information: Sleep News and Research section. All Sleep, All The Time Web site. Available at: http://talkaboutsleep.com/news/ apnea_chest2000_cpap.htm. Accessed August 30, 2001.