If you have ever wondered how much people are seeking an alternative to using their continuous positive airway pressure (CPAP) machines to treat sleep apnea, you need not look any further than the interest generated in a new product called Airing. What is the Airing Micro-CPAP device? Learn about the potential promise of this technology and the many lingering questions about its viability as a new treatment option.
What Is Airing Micro-CPAP?
Invented by Stephen A. Marsh, the Airing Micro-CPAP is proffered as an alternative to standard CPAP therapy. It is touted as a hoseless, maskless, and cordless device that can effectively treat obstructive sleep apnea. It has no described role in treating central sleep apnea, complex sleep apnea, or Cheyne-Stokes respiration.
Its inventor has applied the technology of micro-blowers to its design. These are typically used for heat regulation to prevent overheating of computer chips. By putting hundreds of these micro-blowers in parallel within a small casing, sufficient filtered airflow could be generated that may treat sleep apnea when delivered into the airway via nasal plugs.
The device is anticipated to be small, measuring just 2 inches in length, 1.5 inches in width, and 1 inch in height. It may weight as little as 0.9 ounces. With its internal battery, it is stated to have a run time of more than 8 hours.
Effective, Low-Cost, & Disposable
The solution is the result of Marsh’s research in the area of micro-fluidic pumps in the micro electro mechanical systems (MEMS) space, which identified a host of inefficiencies and limitations with current solutions and led to Marsh’s design for a better micro-fluidic pump design, a design that works just as well moving air. The “micro-blowers” solution in Airing benefits from advances in the “Roll to Roll” (R2R) manufacturing process, which allows for inexpensive mass manufacturing of the solution, and which will allow Airing devices to be low-cost and disposable.
“As someone with a family member who suffers from sleep apnea (my brother), I understand the potential serious health impacts of this condition,” Marsh says. “As a result of recent research, I realized that current pumps possess several deficiencies which severely limit their effectiveness and saw an opportunity to apply a new design to these pumps that could be used in a variety of ways, including treating breathing disorders. The result is a solution that we believe has the potential to address this area, and to help a large number of people live better, healthier lives.”
Airing plans to launch on crowdfunding site Indiegogo in June. The company’s website states: “Sale of the Airing micro-CPAP is subject to FDA approval.”
Many Questions Exist About the Technology’s Viability
Though there is a great deal of interest and media coverage about the Airing device, it is in the preliminary stages of development. The company’s information suggests that they are still actively developing a working prototype. This suggests that beyond the theory and the photography mock-ups, such a working prototype does not yet exist. It may encounter significant problems as the product is developed.
It is suggested that the Airing Micro-CPAP will be disposable after one night of use. It will be powered by a battery, and with nightly disposal, no cleaning will be required. It is suggested that the device is recyclable, but with plastic, metal, and battery components, it is very unclear how that would be possible.
Though there is no hose or power cord, the device itself is, in fact, a mask. It is similar in design to many nasal pillow masks used with CPAP. Sizing may be an issue, as it is with most mask designs. It is unclear how well it will stay placed in the nose, especially when not sleeping on one’s back.
For patients who breathe through their mouths, as most patients with snoring or sleep apnea initially do, it is very likely that air and pressure will escape. Though many learn to breathe through their noses again, nasal congestion or a deviated septum may preclude this. Many who use CPAP require the use of a full-face mask or chinstrap. The company does not seem to address this possibility.
It is very unclear how the Airing device will create the precise positive airway pressure that is needed. It is unknown how the settings will be applied, including those ordered by sleep specialists after standard testing. (In fact, the company’s materials suggest that a pressure for standard CPAP machines range from 1 to 20 cm of water pressure, which is simply not true. This may reveal unfamiliarity with standards of therapy for sleep apnea.) It is not known if the Airing can provide a self-adjusting pressure range, as most modern CPAP devices can.
The company suggests that no additional humidification is provided or necessary. It is stated that the user will simply rely on the nasal passage to humidify the air. This fails to recognize that pressurized air, especially if it escapes through the mouth, will quickly lead to uncomfortable dryness. It seems impossible for a water chamber to be attached to such a small thing.
There is no indication that data tracking is integrated into the device. This is important to demonstrate the effectiveness of the therapy and compliance for insurance payment. If each is thrown away on a nightly basis, external data collection via wireless technology would be necessary. The shell of the device is potentially getting awfully crowded with needed additions.
The proposed chronology will delay availability for years
According to a schedule provided by the company, Airing Micro-CPAP will not be available for at least 2 years. Realistically, this is probably an optimistic prediction for several reasons. After a successful stage of funding, raising around $ 1 million from this writing of numerous hopeful individuals, the work begins now.
Now you must create a functional prototype, not just an attractive photo based on a theory. It is anticipated that this will continue until March 2016. Some of the problems described above could delay it further. To be available to the public, Airing Micro-CPAP must go through the approval and approval of the FDA. It is expected that this can be done based on existing technology and approved by January 2017, but this is not guaranteed. This could be a long process, especially if serious questions must be addressed and clinical research trials are required. Transmission will require a prescription, as do existing treatments for sleep apnea.
Ultimately, who will pay for these devices? This requires insurance companies to join the technology. As has been demonstrated with other recent products, including Provent and Winx, this can be a very difficult path. At an anticipated cost of $ 3 per night use, it is proposed that it will cost the user 60 cents after 80% of insurance coverage for durable medical equipment (although this is not “durable” and may not be eligible). The transmission could cost the average person from $ 200 to more than $ 1,000 per year, depending on the actual insurance reimbursement and the product costs. Compared to existing CPAP therapy, it is not cheap.
The planned date of shipment of the company for July 2017 is highly unlikely and time will tell whether this new technology can become the effective treatment it promises to be. Meanwhile, we expect an optimized design, FDA approval and the development of a production process and a reimbursement scheme that is likely to be extended for years.
The businessman Stephen Marsh, who currently has more than 75 patents in his name, is the founder of Airing LLC, a company that next month will seek funds for what it says is a disposable micro-CPAP device that weighs less than an ounce. The nose, and it has no wires or hoses. Airing says the device will address widespread concerns about non-compliance with CPAP for patients with obstructive sleep apnea.
The Airing design includes battery-powered “micro-blower” technology that blows the amount of air pressure prescribed by the patient’s airway doctor to effectively treat OSA.
While conducting research in another field, Marsh saw the applicability and the need for a new CPAP solution due to a personal connection with the dangers of respiratory disorders. Marsh then shared his design and concept with medical professionals and expert medical experts in the area of respiratory disorders, all of whom, according to him, fully endorsed his approach and proposed solution.
“I think it’s going to be wonderful for people, for the first time we have a treatment that patients will be willing to use, I think Airing will have a tremendous impact,” says Jeffrey Bass, MD, of Brigham & Women’s Hospital and board member. Medical adviser to Airing, in a statement.