From smaller sizes to lighter weights, manufacturers have over the years introduced mask upgrades designed to increase obstructive sleep apnea patient comfort.
A number of obstacles contribute to patient compliance with CPAP therapy, including how comfortable the interface is to wear on a nightly basis. Manufacturers have innovated CPAP mask technology in order to increase patient comfort, which may in turn increase therapeutic compliance and improve patient outcomes.
Comfort and Compliance
According to Mark D’Angelo, sleep business leader for Philips, a patient’s ability to acclimate to wearing a mask each night is the most important factor in determining long-term success with CPAP therapy. As such, an uncomfortable or ill-fitting mask may mean the user will struggle to incorporate it into their daily routine. He says, “For CPAP therapy to be successful, patients must be committed to using their equipment regularly. Our designs are patient driven, to ensure that patients can get their best sleep possible, and feel less like they’re being treated for a condition.”
Susie Justus, LVN, inside clinical specialist at ResMed, also says patient comfort is key in helping the user reap the maximum benefits. “Patient comfort is key, so it’s essential for us to continue developing more comfortable and innovative masks,” Justus explains. “If a patient does not use their mask because of discomfort, then they are not getting the optimal results that consistent therapy usage can deliver.”
Kelly Rudolph, president of Hans Rudolph, says his company strives to exceed in comfort, seal, and durability in its CPAP masks. “We are the designers and makers of all our masks and we take great pride in making a mask that will work. If the mask is not made to be comfortable, then the patient will not be able to sleep with it very well and that concerns us,” Rudolph says.
Interface manufacturers are using feedback from consumers to understand what is currently working, in addition to what types of innovations may be needed in the future. Justus says patient feedback is a critical part of ResMed’s product development process. “Patients are our end users, so their input is vital to how we progress on and improve our products. We’re focused on patient-centric innovation, and we use a variety of different tools to gather feedback,” Justus says.
At Philips, D’Angelo also says that patient insight is a valuable part of the design process. “Philips Respironics employs a variety of approaches, including one-on-one interviews, focus groups, online surveys, and ethnographies, to collect feedback from both patients and sleep professionals,” says D’Angelo. “It’s important to get input from people who are actually using the masks—what they think works, what doesn’t, the biggest challenges, and what could be improved.”
For example, in creating its newest DreamWear mask, the Philips team gathered input from hundreds of patients. D’Angelo explains, “Many patients told us that they had to modify how they slept, perhaps adjusting their usual position, in order to make PAP therapy work for them. We took this feedback into account to create DreamWear, providing a mask that enables patients to have freedom of movement in bed to sleep however they’d like.”
Hans Rudolph also values customer input, and the company also gathers insight from healthcare professionals. Rudolph says, “We have always gathered input from the field such as the end user patients, respiratory therapists, sleep technicians, nurses, doctors, and others who fit masks and hear the patients’ feedback (such as the home care dealers). We get the information via phone calls to all, from surveys and customer questionnaires, and at congresses and symposiums.”
Specific Comfort Innovations
According to D’Angelo, there has been a trend in the past 10 years toward masks that are lighter and smaller. “At Philips, our newer mask designs are smaller and sleeker. Most of the weight reduction is due to a decrease in the overall footprint of the mask and designs that allow for greater performance in a smaller package,” D’Angelo explains. “For example, the under-the-nose cushions on both DreamWear and Amara View result in masks that are smaller and eliminate irritation on the bridge of the nose and inside the nostrils.”
According to Justus, CPAP masks today are much lighter in weight and have fewer parts, which can make them easier to use and keep clean. To illustrate this point, Justus says, “ResMed’s AirFit P10 and AirFit P10 for Her masks specifically are 50% lighter than their predecessors. They are also 50% quieter, and that combination has been shown to deliver more than 40 minutes of additional sleep per night.”1
Manufacturers can achieve a smaller size in a number of ways, from the actual interface to streamlined designs. To begin, a smaller CPAP interface can contribute to a more petite size. “The actual interface is what makes CPAP masks smaller. Being smaller, lighter, and looking less like a medical device all play into a patient wanting to try a particular mask, headgear included,” Justus explains. “The industry has come from thick wide straps in the past to very lightweight materials that allow the skin to breathe without compromising the frame and sealing ability of the interface.”
According to D’Angelo, “It depends on the mask, but generally these new designs have been streamlined to include no forehead arms or pads, or cushions that do not cover the nose bridge or need to be inserted into the nose. [For example] in DreamWear’s design, airflow passes through the frame along the sides of the face, making the mask more stable and smaller where it matters.
“There are a lot of benefits for the patient when they can use a smaller mask. Smaller masks feel more normal and natural, reduce claustrophobia, and enable patients to carry on with their nighttime routine.”
Justus echoes a similar sentiment, saying: “Smaller masks are less obstructive and allow patients to more easily maintain their nightly routines…without the mask becoming an obstacle.”
The 7600 V2 Full Face and 6860 Series QUEST masks from Hans Rudolph allow a patient to wear glasses. Rudolph explains, “This allows the patients to read and watch TV and avoid feeling claustrophobic and blinded prior to falling asleep. This also adds safety if they wish to disconnect the tube with our Easy Release and walk to the bathroom, or elsewhere, with the mask on.”
Overall, D’Angelo says smaller masks can give patients more freedom to sleep how they want.
Seals and Parts
Older mask parts have been replaced with more modern materials to create a streamlined mask, and seals have been improved with technological advancements. For improved seals, overall design has enhanced this vital feature. “To improve seals on CPAP masks, we’ve made improvements to overall mask design, including developing masks specific to different facial shapes and features,” explains Justus. “By improving mask fit and making them easier to use, our goal is for sleeping in them to become second nature for patients.”
D’Angelo also says mask design has helped improve mask seal. D’Angelo says, “Enhanced design tools have led to more aesthetically pleasing, comfortable designs. Specifically, the under-the-nose cushion was made possible due to these advancements.”
For Hans Rudolph masks, Rudolph explains that the sealing flange geometry and construction have changed with each series mask to improve the seals. Rudolph says, “We added multiple layers and baffles in the sealing flange around the face and made the flange geometry contour smoother to follow a wide range of face curvatures. We continue to make more sizes…to fit a wider range of face sizes and types.”
The mask geometry design improvements on each new mask series developed by Hans Rudolph help eliminate older mask parts, according to Rudolph, and he says the 7600 CPAP Vmask is one such example. “Our older series 7600 CPAP Vmask had a button-on Sensa Seal that is a second layer seal over the nose bridge. We simply incorporated that double seal in the next generation of the 7600 Series V2 Mask and other series V2 Masks where we have different swivels that are mounted on to them,” Rudolph says.
D’Angelo explains that with the Philips DreamWear mask, the Philips team was able to eliminate the tubing at the front of the face and route airflow through the frame. According to D’Angelo, “[This] enables us to streamline the mask and provide the patient with more freedom to move throughout the night.”
An important aspect of comfort for CPAP mask wearers is protecting the skin, and recent innovations can prevent skin breakdown. “We incorporate…high quality silicone rubber molded in a geometry and wall thickness that allow it to seal easily on a wide range of face sizes and shapes without incorporating a hard frame that pushes on the skin and causes skin marks, breakdown, and sores with potential for infections,” explains Rudolph. “Our design that eliminates a hard frame…is great for home use but also great in hospitals as they have infection issues liability to deal with.”
In addition, protecting the more sensitive parts of the face is essential. “The ability to avoid sensitive areas of the face is critical. This includes the nose bridge and the inside of the nostrils,” D’Angelo says. The Philips Amara View features an under-the-nose full-face design that allowed the makers to eliminate nose bridge irritation that can be associated with over-the-nose cushions.
Other mask features can also contribute to a more comfortable user experience. According to Justus, “Noise level, tightness of headgear, straps on a patient’s face, and weight distribution are all important considerations when it comes to innovating on mask comfort.”
The Comfort Zone
“I think that there will be continuous momentum toward patient-centric designs. At Philips, we’re interested in hearing what does and doesn’t work from real OSA [obstructive sleep apnea] patients, so we can use that feedback to evolve our masks to meet patient needs and desires,” says D’Angelo.
According to Rudolph, Hans Rudolph will continue to incorporate soft materials, advanced mold making, and complex mask surface geometries to produce good seals and comfort for CPAP mask users. “This will make the job of our respiratory therapy customers much easier and allow better respiratory therapy outcomes for them in their daily jobs in sleep labs, hospitals, clinics, long- and short-term care facilities, etc,” says Rudolph.
Overall, the present and future innovations made for comfort will help improve patient compliance and enable patients to reap the therapeutic benefits of CPAP therapy. Justus says, “Innovation should always support effective therapy. As mask developers continue to innovate and improve, competition to make the best mask will increase, and the patient will ultimately benefit from improved design.”
Cassandra Perez is associate editor of Sleep Review. A version of this article also appeared in the March 2016 issue of sister publication RT Magazine.
1. ResMed Clinical Study Comparing AirFit P10 to Swift FX FECS3. Retrieved from www.resmed.com