iNAP Negative Air Pressure Therapy Gains Momentum as CPAP Alternative

By Alyx Arnett 

Sleep specialists can increase their role in the early detection of cardiac comorbidities in sleep apnea patients. Sleep Review’s cardiology-sleep solutions column shares new technologies that can help. Email [email protected] with solutions you’d like to see featured here.

The iNAP device by Somnics, a Redwood City, Calif.-based company, is gaining recognition as a US Food and Drug Administration (FDA)-cleared alternative to CPAP therapy for all severity levels of obstructive sleep apnea (OSA). Using intermittent negative air pressure therapy, iNAP stands out as an innovative solution, and its profile has been elevated by recent achievements, including recognition from the American Heart Association (AHA).

Somnics was selected as one of five to participate in the inaugural AHA Heart and Brain Health Accelerator, an initiative designed to advance solutions with the potential to improve cardiovascular and neurological outcomes. The AHA added sleep to its list of modifiable components for cardiovascular health in 2022.

In a separate recognition, Somnics was also named to the MedTech Innovator 2024 Cohort for its “effective, easy, and portable treatment for all severities” of OSA. With an acceptance rate of 5%, the four-month program culminated with 65 companies competing for $800,000 in non-dilutive funding. Somnics made it to the final four in the Mid-Stage Competition.

“I’m trying to leverage these connections to spread the word among doctors that, yes, there are other alternatives to CPAP that the patient will use and bring that awareness to the community,” says Somnics general manager Olivier Lauzeral.

Key Takeaway: Recent accolades, along with efforts by Somnics’ leadership, aim to raise awareness among physicians and the broader community about iNAP as a treatment for obstructive sleep apnea.

What Is iNAP? 

iNAP consists of a flexible mouthpiece, tubing, and a compact battery-powered console about the size of a smartphone. It delivers light suction inside the oral cavity, moving the tongue forward and away from the airway to prevent obstruction, allowing the patient to breathe naturally through the nose. 

Once the pump reaches a target pressure, it stops pumping and holds the pressure, reactivating only to restore the seal if the tongue shifts out of position. This means the pump is idle most of the time, making it quiet for the user and bed partner. Additionally, its low energy consumption allows it to hold a charge for up to five or six nights.

iNAP uses oral negative air pressure for the treatment of obstructive sleep apnea in adults. Photo credit: Somnics

iNAP builds on earlier efforts to harness negative pressure therapy for OSA, including ApniCure’s Winx, which ceased operations in 2017. Somnics, which had already created its iNAP prototype at the time, acquired ApniCure’s assets, including inventory and intellectual property, to protect the invention and support its global development efforts.

Key Takeaway: The heir to Winx, iNAP delivers light suction inside the oral cavity and idles once it reaches a target pressure.

Who Does iNAP Work For?

Clinical studies suggest iNAP improves the apnea-hypopnea index (AHI) in people with all OSA severity levels. In a study of 32 patients with moderate to severe OSA in Taiwan, the clinical response rate was 75%.1 The baseline AHI of 32 ± 11.3 decreased to 8.7 ± 9.4. Another 28-day study of 63 OSA patients found that 52% responded to iNAP.2 

Research has also sought to identify which patients are most likely to benefit from iNAP and to better understand its mechanism of action. One study used magnetic resonance imaging and sleep data to differentiate responders from non-responders.3

According to the Tzu-Chun Hung, et al, study, anatomical predictors of iNAP response include:

• larger angulation of sella-articulate-gonion,
• longer distance of the anterior nasal spine to the posterior nasal spine, and
• elongated tongue.3

Conversely, patients with features such as oral tissue redundancy, an enlarged middle pharyngeal space, or a longer distance from the hyoidale to the mandibular plane were less likely to respond.3

Key Takeaways: iNAP is cleared for all OSA severities; however, certain characteristics make some more likely to respond to this therapy than others.

Addressing OSA’s Cardiovascular Impact Challenges 

According to a controversial report by the Agency for Healthcare Research and Quality, there is inadequate evidence to show whether CPAP therapy improves cardiovascular outcomes in patients with OSA.4 Lauzeral positions iNAP as a patient-friendly alternative that could address the adherence challenges associated with CPAP and, in turn, play a role in mitigating cardiovascular comorbidities. 

However, there is also no evidence that iNAP improves cardiovascular outcomes in OSA patients. Laurezal notes this would require a large study, which is thus far not planned. For now, Laurezal focuses on high adherence rates for iNAP.

“To make the patient compliant and use it, you need to design something that people will love. That means almost no side effects and no impact on their lifestyle and their bed partner’s lifestyle, and I do believe that we achieved all those goals with iNAP,” Lauzeral says. 

Key Takeaway: Somnics focuses on iNAP’s adherence rates as a potential differentiator in the quest for sleep apnea therapies that improve long-term cardiovascular outcomes.

Case Study: Woman Bypasses Ablation With iNAP 

Anecdotal evidence exists for iNAP’s promise in alleviating cardiovascular comorbidities. One such case is that of Rosemary McQuinney.

McQuinney, then 75, woke up one morning feeling unwell. When she checked her blood pressure, it read 120 over 125—a spike from her usual 120 over 70. “My heart was just jumping and flipping. I could feel it doing somersaults in my chest,” she recalls.

McQuinney called an ambulance and was taken to the emergency room, where physicians suspected sleep apnea. McQuinney was referred to the Eisenhower Sleep Clinic and was subsequently diagnosed with severe OSA and prescribed CPAP. As someone who identified as a mouth-breather and snorer, she says the diagnosis made sense.

However, McQuinney struggled with CPAP. A full-face mask was intolerable, and a nasal pillow mask irritated her already sensitive sinuses. After weeks of failed attempts, she gave up. “The doctor said, ‘You have to do something because you can’t go on like this,’” McQuinney says.

Her cardiologist recommended an ablation to address her arrhythmias, but McQuinney hesitated, calling it a major procedure that required serious consideration. She had heard of hypoglossal nerve stimulation for OSA but was deterred by the idea of surgery. Then, a neighbor mentioned iNAP for OSA. Intrigued but skeptical, she researched the device and discussed it with her sleep doctor, who recommended she give it a try.

The results were immediate, she says. The first night she used it, she woke up with normal blood pressure and no arrhythmias, McQuinney says. Initially, she thought it was a coincidence, but the improvements persisted. After using it for a couple of weeks, she had another sleep study, which showed her AHI had dropped to 9. 

Two years later, she continues to use iNAP, for about six hours each night. “It was like a miracle. I thought it couldn’t work all the time, but it has,” says McQuinney, now 77.

Key Takeaway: Diagnosed with severe OSA, Rosemary McQuinney failed CPAP and opted for iNAP, to which she has been adherent for two years. She credits iNAP with resolving her cardiac arrhythmia.

Treating OSA Earlier to Reduce Comorbidities

While iNAP provides an alternative for patients who struggle with CPAP, Lauzeral also envisions it as a tool to encourage earlier treatment of OSA, as the average age of diagnosis and treatment is 53.5

Lauzeral says, “If I could get the 30- and 40-somethings to start with treatment, they don’t develop the comorbidities that they would if they postpone the CPAP by 10 or 15 years.” 

To lower barriers to entry, Somnics is adopting a more direct-to-consumer approach for iNAP. As a Class II device, iNAP requires a prescription, but Somnics uses platforms like Facebook and Instagram to engage potential patients. Interested individuals can share necessary information with their physicians, who generate a prescription sent to Somnics. Patients can then order the device online. Patients are offered a video onboarding session to help them use the device and can download an app that allows adherence data to be shared with physicians and for the device to be titrated remotely. 

In the United States, approximately 2,500 patients are currently using iNAP, with an average adherence rate of around 65% after a year, according to Lauzeral. Currently, iNAP is not covered by insurance, and, according to its website, the cash-pay price is $1,199.

Key Takeaway: Somnics envisions iNAP as a tool to entice younger patients to treat OSA.

Changing Attitudes Toward OSA Treatment

Somnics is focused on expanding its reach, including raising funds to build a US-based sales team and conducting post-market clinical research to provide physicians with additional data. 

Leveraging connections with the AHA and the MedTech Innovator program, Lauzeral is not only raising awareness about iNAP among the cardiology community but also positioning it as a more comfortable, less stigmatized option to encourage earlier and accessible treatment for OSA. By addressing barriers to diagnosis and treatment, Somnics aims to make a lasting impact on both patient outcomes and the broader understanding of OSA’s link to cardiovascular health.

Somnics general manager Olivier Lauzeral attends the American Heart Association’s Scientific Sessions 2024, where he presented about iNAP. Photo credit: Somnics

In addition to saying iNAP lends itself to higher adherence than CPAP, Lauzeral posits that the negative pressure device has several advantages over the more well-known CPAP alternative of oral appliance therapy. According to Laurezal, advantages to iNAP include recording objective monitoring data, no time spent building a custom device, clearance for all OSA severity levels (only a few oral appliances have FDA clearance for severe OSA), and no potential changes to a patient’s bite.

“We made it a point to ease the adoption and make it so comfortable that patients keep using it,” Lauzeral says. “And since we’re cleared for all severities of OSA, it makes us a game-changer in trying to bring many patients to a successful management of their OSA.”

Key Takeaway: Somnics focuses on expanding iNAP’s reach and positioning it appropriately as a CPAP alternative.

Photo caption: A photo illustrates a man wearing iNAP while sleeping.

Photo credit: Somnics

References:

1. Nilius G, Farid-Moayer M, Lin CM, et al. Multi-center safety and efficacy study of a negative-pressure intraoral device in obstructive sleep apnea. Sleep Med. 2024;119:139-46.
2. Hung TC, Liu TJ, Lu TM, et al. Building a model to precisely target the responders of a novel intermittent negative air pressure device-with mechanism definition. Sleep Med. 2020;72:20-7. 
3. American Academy of Sleep Medicine. Sleep apnea patient experience: describing the physical, emotional, and functional impact of sleep apnea and its treatment. 2017. Accessed 2024 Dec 2. https://aasm.org/resources/pdf/sleep-apnea-patient-experience.pdf
4. Balk EM, Adam GP, Cao W, et al. Long-term health outcomes in obstructive sleep apnea: a systematic review of comparative studies evaluating positive airway pressure and the validity of breathing measures as surrogate outcomes. 2022 Dec 1. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/sleep-apnea/sleep-apnea-report.pdf
5. American Academy of Sleep Medicine. Hidden health crisis costing America billions: underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. 2016. Accessed 2024 Dec 2. https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf

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