From smaller sizes to lighter weight masks, manufacturers have introduced new innovations for continuous positive airway pressure masks and interfaces designed to increase patient comfort.
By Cassandra Perez
Comfort Equals Compliance
Manufacturers have developed new innovations for CPAP masks intended to increase patient comfort, which may in turn increase therapeutic compliance and improve patient outcomes. 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 and may ultimately not use it.
“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,” D’Angelo said.
Poor adherence to CPAP therapy is common. According to 2009 research published in the Journal of Clinical Sleep Medicine, 29% to 93% of patients were non-adherent to therapy when adherence was defined as greater than four hours of CPAP use per night.1
Therefore, comfort is a primary factor in helping the user to reap the maximum benefits from their therapy, said Susie Justus, LVN, inside clinical specialist at ResMed. “Patient comfort is a key, so it’s essential for us to continue developing more comfortable and innovative masks,” she explained. “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.”
Informed by Patient Feedback
In order to design and construct a CPAP mask that is comfortable to wear, manufacturing companies are using feedback from consumers to understand what is currently working and what types of innovations may be needed in the future. Justus said 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 said.
D’Angelo agreed that patient insight is a very valuable part of the design process at Philips. “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,” said 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 interface, DreamWear, the Philips team gathered input from hundreds of patients. “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,” D’Angelo explained. “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.”
Patients aren’t the only source of insight in the design process. Mask manufacturer Hans Rudolph Inc values input from customers, but the company also gathers insight from healthcare professionals to improve and upgrade their products, according to company president Kelly Rudolph. “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 homecare dealers. We get the information via phone calls to all, surveys, customer questionnaires, and at congresses and symposiums,” Rudolph said.
Innovations for Comfort
Once companies receive the user and clinician feedback, the goal becomes incorporating that information into the design and production of more comfortable, effective devices. “Enhanced design tools have led to more aesthetically pleasing, comfortable designs,” said D’Angelo, who noted the under-the-nose cushion was made possible due to these advancements. Furthermore, from smaller size masks to CPAP masks that are lighter in weight, manufacturers and designers are introducing new innovations intended for a more comfortable user experience.
According to D’Angelo, there has been a trend in the past 10 years towards masks that are lighter and smaller, which can be beneficial for patients. “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,” he said. “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.”
Meanwhile, Justus said 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 explained: “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.”2
A CPAP mask that is smaller in size is another innovation that can increase patient comfort at bedtime. Manufacturers can achieve this 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 said. “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 number of benefits of a smaller size mask, but primarily it can offer the wearer a more natural fit that can enhance comfort. “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,” said D’Angelo, who added that smaller masks can give patients more freedom to sleep how they want.
Justus echoed that sentiment and said increased mobility and comfort are the most significant benefits of smaller sized masks. “Smaller masks are less obstructive and allow patients to more easily maintain their nightly routines…without the mask becoming an obstacle,” she said.
The 7600 V2 Full Face and 6860 Series Quest Mask from Hans Rudolph allow a patient to wear glasses while wearing their mask, which is a beneficial feature of the masks’ design. “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,” Rudolph explained.
Seals and Parts
To improve comfort and user experience, older mask parts have been replaced with more modern materials to create a streamlined mask. At the same time, seals have been improved by advancements in technology and by embracing the reality that one size doesn’t fit all. “To improve seals on CPAP masks, we’ve made improvements to overall mask design, including developing masks specific to different facial shapes and features,” said Justus. “By improving mask fit and making them easier to use, our goal is for sleeping in them to become second nature for patients.”
For Hans Rudolph masks, the sealing flange geometry and construction has changed in each series the company designs, Rudolph emphasized. This has improved the seals of their interfaces. “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,” Rudolph said.
The mask geometry design improvements on each new mask series developed by Hans Rudolph helps eliminate older mask parts, according to Rudolph, and he said 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,” he explained.
D’Angelo added 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. “[This] enables us to streamline the mask and provide the patient with more freedom to move throughout the night,” he said.
An important aspect of comfort for CPAP mask wearers is protecting the skin. To do so, Hans Rudolph incorporates high quality materials and a unique design in order to prevent breakdown of the skin. “We incorporate…high quality silicone rubber molded in a geometry and wall thickness that allows 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,” explained 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.”
D’Angelo said the Philips team hears frequently that obstructive sleep apnea (OSA) patients do not want to be embarrassed when wearing a CPAP mask and want to be able to go about their nighttime routine as normal. As such, newer masks offer patients an unobstructed view to allow the user to wear their glasses or watch television before bed, according to D’Angelo. D’Angelo says, “With options like Philips’ DreamWear, we’re working to ensure that the mask a patient interacts with every night is more comfortable, less intimidating, and feels less like a medical device.”
In addition, protecting the more sensitive parts of the face is essential for patient comfort. “The ability to avoid sensitive areas of the face is critical. This includes the nose bridge and the inside of the nostrils,” D’Angelo states. The Philips Amara View features an under-the-nose full-face design that allowed the makers to eliminate nose bridge irritation often 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
Rudolph said his company strives to exceed in comfort, seal, and durability of their CPAP masks as patient comfort is of the utmost importance. “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,” he said.
According to Rudolph, his company 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 lab, hospitals, clinics, long- and short-term care facilities, etc,” he said.
The emphases on smaller, lightweight, better sealing interfaces with patient-centered designs will continue, manufacturers expect. “I think that there will be continuous momentum toward patient-centric designs,” said D’Angelo. “At Philips, we’re interested in hearing what does and doesn’t work from real OSA patients, so we can use that feedback to evolve our masks to meet patient needs and desires.”
Overall, present and future innovations made for comfort will help improve patient compliance and allow patients to enjoy the therapeutic benefits of CPAP therapy, according to Justus. “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,” Justus said. RT
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Parthasarathy S, et al. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2009;9(6). http://dx.doi.org/10.5664/jcsm.2744
ResMed Clinical Study Comparing AirFit P10 to Swift FX FECS3. Retrieved from www.resmed.com