Over 80 Million Americans Affected by Sleep Apnea: Disruptive Innovations Transforming Treatment

Sleep is one of the three pillars of health —together with nutrition and movement—, yet for nearly 80 million U.S. adults with obstructive sleep apnea (OSA), restful nights remain elusive.^1,2 This chronic condition causes airway blockages during sleep, leading to oxygen deprivation and repeated breathing interruptions. Beyond its impact on sleep quality, untreated OSA increases the risk of serious health issues, including cardiovascular disease, type 2 diabetes, and anxiety. Alarmingly, 90% of those with OSA are undiagnosed, compounding its status as an underestimated public health crisis.³

While CPAP machines have historically been the frontline treatment, their design often results in discomfort and non-compliance. Nowadays, patients and healthcare professionals are seeking less invasive and more user-friendly alternatives. Emerging treatments, such as advanced oral appliances, innovative neurostimulation systems, and FDA-approved weight loss medications, reflect a growing recognition of OSA’s complexity and the need for patient-centered care solutions. As awareness rises, so does the demand for accessible and effective options that go beyond traditional paradigms.

The Evolution of OSA Treatments

The journey to treat obstructive sleep apnea (OSA) has not seen a significant front-line advancement since the advent of CPAP back in the mid-1980’s. Historically dismissed as merely a snoring issue, OSA is now recognized as a serious medical condition with life-threatening consequences. Early interventions primarily focused on managing symptoms, often through lifestyle changes or rudimentary mechanical devices. However, as understanding of the condition grew, so did the sophistication of treatment options.

Today, treatments range from continuous positive airway pressure (CPAP) machines to surgical procedures and cutting-edge non-invasive solutions. While these advancements have improved patient outcomes, each approach carries its own set of limitations, underscoring the need for ongoing innovation. Below is a breakdown of common OSA treatments and their associated challenges.

OSA Treatments and Their Limitations

CPAP: This device uses a mask to deliver constant air pressure, keeping airways open during sleep.

Limitations: CPAP therapy as a solution for OSA is limited by the following: 

• Patients hate it: leading to low adoption and compliance. Between 30% to 50% of users can’t tolerate the mask and stop using CPAP.⁴
• Undesirability: prevents patient willingness to test (diagnosis) and compliance. Many avoid testing because CPAP is the standard treatment, and they fear its noise, discomfort, and inconvenience.
• Requirement to use CPAP nightly for life: Most people prescribed CPAP will need it indefinitely, as it only works while in use and doesn’t prevent future breathing issues. Patients are expected to use the machine for at least 4 hours per night within a 90-day period.^5,6
• Failure to address the underlying root cause: CPAP is a management tool, not a cure. While it can effectively reduce symptoms, it does not eliminate sleep apnea or provide long-term relief. It does not address the structural issues causing sleep apnea, such as a naturally narrow airway, or a recessed jaw. 

Additional Limitations:

• Claustrophobia and difficulty sleeping with the device.
• Risk of infections and nasal congestion from prolonged use.
• Frequent cleaning and maintenance add to the inconvenience.
• Discomfort and skin irritation from the mask.

Surgical Interventions: Includes tissue removal, jaw repositioning, nasal surgeries to widen airways, among others.⁷

Limitations:

• Surgery can be prohibitively expensive, often not fully covered by insurance.
• Invasive with risks of infection, bleeding, and anesthesia complications.⁸
• Unpredictable outcomes and low success rates in some patients.⁹
• Patients often face longer recovery periods. Jaw surgery complete healing can take up to 12 months.¹⁰
• It may still require additional treatments, such as CPAP, post-surgery.

Oral Appliances (Mouthpieces): Custom-fitted devices reposition the jaw or tongue to keep airways open.

Limitations:

• Potential Side Effects: May cause Temporomandibular disorder (TMD), jaw pain, bite changes, or excessive salivation.
• Custom fittings: Requires custom fitting and regular adjustments.
• Replacement Frequency: Periodic replacement of devices required every 2-3 years 
• Declining Effectiveness: Effectiveness eventually declines over time, with success rates dropping from 79% at 3–6 months to 52% at five years.¹¹
• Failure to address the underlying root cause: Like CPAP, oral appliances do not address causes like underdeveloped jaws or palates, it just keeps the airway open during sleep, but once the device is removed, the underlying problem remains.
• Lifelong Use Required: Oral appliances, like CPAP, are long-term solutions that require nightly use to manage symptoms.

Exploring New Medications Treatments for OSA

Weight Loss Drugs: The FDA recently approved Zepbound, marking it as the first prescription medication specifically designed to treat OSA in patients with obesity.¹² Losing weight can reduce airway blockages and alleviate the severity of OSA symptoms and early studies have shown significant improvement in sleep apnea symptoms among users. 

Limitations:

• Costs between $400 and $550 / month. Insurance coverage is limited.
• Effectiveness may vary by individual.
• Long term effects unknown. Requires further studies.
• Not suitable or effective for all OSA patients

Electrical Stimulation of the Upper Airway: uses targeted electrical impulses to stimulate the muscles that keep the airway open during sleep.¹³

Limitations:

• Require surgical intervention, specialized equipment, and expertise.
• Not as effective with patients with high BMI or obesity.
• Limited reported data

AD109: this oral drug combines aroxybutynin and atomoxetine. Aroxybutynin treats overactive bladder symptoms, while atomoxetine addresses ADHD.¹⁴ Together, they are believed to prevent airway collapse and help maintain sleep, providing a potential non-invasive treatment for OSA.

Limitations:

• Still in early-stage development with limited clinical data.
• Needs larger-scale trials to confirm long-term safety and effectiveness.
• Currently there is no FDA approval for OSA treatment.

Beyond Snoring: The Urgent Need for Public Awareness

Despite advancements in treatment options, significant gaps persist in meeting the needs of patients with obstructive sleep apnea (OSA) and the healthcare system. Many individuals still think of OSA as “just snoring,” failing to recognize the severe health risks it poses. Even physicians often overlook OSA, leading to a lack of testing and preventing patients from receiving any kind of treatment. This misconception underscores the need for greater public education to highlight the serious consequences of untreated OSA and the life-changing potential of effective treatments. 

For patients, access to comfortable and accessible therapies remains a challenge. Traditional treatments like CPAP often lead to non-compliance due to discomfort and inconvenience, leaving many without adequate relief. 

For the healthcare system, the financial toll of untreated OSA—estimated at over $250 billion annually in the U.S.—demands scalable, cost-effective solutions that can improve early detection and treatment adherence. Addressing these unmet needs is essential not only to reduce the financial and health burdens of OSA but also to improve the quality of life for millions.

Empowering Patients: The Impact of Non-Surgical Treatments

Recent advancements in medical technology are paving the way for a new era of non-invasive treatments for obstructive sleep apnea (OSA), offering patients more comfortable and effective alternatives to traditional therapies. Among these innovations are FDA-cleared oral appliances from Vivos Therapeutics that address the root causes of OSA by redeveloping and repositioning the tissues that define the airway and help it function. Unlike CPAP machines, which require nightly use and can be uncomfortable, or surgical procedures that come with inherent risks, these unique oral devices provide a non-surgical, non-invasive, and non-pharmaceutical solution. The treatment duration typically lasts just 12, with 80% of patients experiencing significant resolution of their symptoms.

Furthermore, clinical studies have shown that 97% of adult Vivos patients report symptom relief, and almost 30% achieve full recovery, highlighting the effectiveness of these devices. These oral appliances are becoming a game-changer, offering a more sustainable and patient-friendly approach.

Key Benefits:

• Addresses Root Cause: Unlike CPAP and traditional oral appliances, devices like Vivos CARE correct the underlying structural issues causing OSA, remodeling the tissues of the oral cavity and jaws, assisting airway function.
• Limited Treatment Times: Most patients complete treatment in 12 months or less, making it a faster alternative to lifelong CPAP or oral device use.
• Improved Compliance: Comfortable and easy-to-use designs encourage consistent adherence to treatment plans.
• Reduced Risks: Non-invasive and non-surgical options significantly lower the risk of complications.

Redefining OSA Care: Overcoming Design Challenges for Better Patient Compliance

Designing effective interventions that can actually resolve obstructive sleep apnea (OSA) remains a significant challenge due to the complexity of the condition and variations from patient to patient. Traditional treatments, such as CPAP machines and mandibular advancement oral appliances, focus on alleviating the effects of OSA by attempting to keep the airway open during sleep. However, these treatments do not address the underlying anatomical factors—such as underdeveloped structural features, airway tissue patency, or anatomical airway obstructions that often constitute the primary origins of OSA. This makes symptom management easier but leaves the core problems unaddressed, which can result in suboptimal long-term outcomes for patients.

Additionally, the challenge of designing devices capable of evoking a tissue remodeling and airway enhancement effect while maintaining comfort, ease of use, and patient compliance adds another layer of complexity. Many of the more invasive or uncomfortable treatments, such as jaw surgeries or CPAP, can lead to low patient acceptance and long-term dissatisfaction. This leads to a higher rate of abandonment and non-compliance, which can ultimately affect treatment efficacy and patient outcomes.

The Growing Role of Telemedicine in OSA Diagnosis and Treatment

The lack of proper diagnosis in obstructive sleep apnea (OSA) continues to contribute to its widespread impact, with millions at risk for severe health complications. Traditional in-lab sleep studies, with their high costs and logistical barriers, have made timely diagnosis challenging. However, telemedicine and home sleep testing technology are revolutionizing the landscape of obstructive sleep apnea (OSA) care, by offering accessible and affordable solutions for diagnosing and managing OSA, especially those in rural or underserved areas.

Home Sleep Tests (HSTs) equipped with advanced diagnostic technologies offer clinical-grade accuracy comparable to in-lab polysomnograms (PSGs) at a fraction of the cost. With a simple Bluetooth-enabled finger ring device connecting to a smartphone, patients can complete their sleep assessments comfortably from home. This innovation dramatically reduces diagnostic costs—often under $50 for healthcare providers—and eliminates the logistical challenges associated with traditional sleep labs.

For patients, the affordability and convenience of telemedicine-enabled HSTs are game-changing. Typical insurance reimbursements for these tests range from $150 to $250, making them far more accessible than the $2,000–$6,000 price tag of in-lab studies.¹⁵ Moreover, patients avoid lengthy wait times, often exceeding 90 days, associated with backlogged sleep centers.

Trends in OSA Device Design: Innovations on the Horizon

As OSA treatment continues to evolve, innovative device design and technology are set to revolutionize patient care over the next decade. The future of OSA diagnostics and management will be characterized by integrating advanced materials, sophisticated wearables, and cutting-edge smart technologies that enhance patient experience and improve clinical outcomes.

Wearables: The emergence of new wearable devices promises to redefine how we screen and diagnose OSA. Unlike traditional equipment, these devices leverage novel sensors and AI-driven algorithms to collect and analyze data in real time. Future iterations of these wearables will likely focus on miniaturization and improved comfort, making them suitable for long-term use without the cumbersome nature of existing devices. 

Wearable gadgets such as rings and wristbands are designed to gather data over extended periods, tracking vital metrics like heart rate and movement.¹⁶ By employing advanced technologies such as photoplethysmography (PPG) and inertial measurement units (IMUs), these next-generation devices can deliver critical insights into cardiac and respiratory functions, which are essential for OSA diagnosis and monitoring.

Limitations:

• Wearable technology today still lacks the precision of in-lab diagnostics, potentially leading to inaccurate results.
• Battery technology limitations and the need for continuous monitoring are the current barriers to more consistent and accurate clinical results.
• Patients may struggle with consistent use, especially if devices are uncomfortable.

Smart Technologies and IoT: The key to this future lies in creating interconnected devices that harness the power of the Internet of Things (IoT). For instance, advancements like the IoT-based wireless polysomnography system will revolutionize sleep diagnostics by enabling at-home assessments that eliminate the need for restrictive settings.¹⁶ These innovations herald an era where patients are not just passive participants in their care but active monitors of their health.

Limitations:

• IoT systems raise concerns about the security and privacy of sensitive patient data.
• Integration between different devices can lead to compatibility issues, limiting effectiveness.
• Limited access to technology or reliable internet may hinder the adoption of IoT-based solutions, especially in rural areas.

A Patient-Centric Paradigm: The evolution of OSA treatment will fundamentally shift towards a more patient-centered approach. Initiatives to integrate these novel technologies into current care models must be guided by empirical evidence and patient preferences. Clinicians must stay informed about these advancements to leverage them appropriately, ensuring improved patient outcomes and enhanced quality of life.

Limitations:

• Patients may struggle to understand or properly use new technologies, impacting adherence.
• Finding the right device or treatment for each individual will still require the specific knowledge and direction of trained clinicians to avoid patients resorting to trial-and-error approaches.
• Total cost of care considerations based on today’s most advanced technologies may still render this type of patient-centered solution inaccessible to many patients.

The future of OSA diagnosis and treatment is poised for remarkable transformation. Advances in lower-cost, user-friendly diagnostic technologies will enable more patients to receive timely identification and care. At the same time, new treatments are shifting away from “manage the disease until the patient dies” paradigm. Most patients want to reclaim their health and wellness. This calls for treatments that go beyond symptom control—offering the potential to reverse or resolve the condition. Already, patients are benefiting from more precise diagnostics and devices that empower them to manage their health more effectively. Much work remains, however, and as we embark on this journey of innovation, the collaboration between technologists, clinicians, and patients will be paramount in shaping a new era of OSA care.

Designing the Future of OSA Treatment

As the landscape of obstructive sleep apnea (OSA) treatment continues to evolve, medical device developers and manufacturers have a unique opportunity to drive meaningful change by focusing on innovations that not only address the symptoms but also tackle the root causes of the condition. To truly revolutionize OSA treatment, it’s crucial to prioritize designs that offer a clear path of rehabilitation and restoration of optimal airway form and function. Among the emerging solutions, the Vivos CARE oral medical devices represent hope of a true cure. These products currently represent the only FDA-cleared, non-surgical clinical intervention available that offers non-invasive, effective, short-term-duration treatment with the chance of complete and lifelong OSA symptom resolution, without further interventions. For children with OSA, these devices stand alone as the only non-surgical, non-CPAP, FDA-cleared options for moderate to severe OSA.

In the future, only technologies that feature safe, effective, non-invasive, short-term interventions with long-term and lasting symptom resolutions will align with patient health goals, preferences, and lifestyle objectives. Even today, when newly diagnosed OSA patients are presented with all treatment options, over 80% of them are reported to select this rehabilitative and restorative approach over traditional CPAP or surgery.

Product developers and manufacturers with a variety of approaches and methodologies need to also step up and step in. No single company or technology can do this alone or in isolation. The market and diversity of approaches required is simply too vast. We need more and better means of effective and accurate diagnosis, and for patients who test positive for OSA, they need better options that can help them reach their lifestyle and health goals.

We look forward to continuing this journey of discovery and progress until the day when this pernicious and deadly disease we call sleep apnea is extinguished from the earth.

References:

1. National Institutes of Health (NIH). “NIH-Funded Study Explains Link to Increased Cardiovascular Risks for People with Obstructive Sleep Apnea.” National Institutes of Health (NIH), 26 July 2023, nih.gov/news-events/news-releases/nih-funded-study-explains-link-increased-cardiovascular-risks-people-obstructive-sleep-apnea.
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10. Maranon, George A. “What to Expect after Corrective Jaw Surgery, Post-Op Instructions.” Drmaranon.com, 2024, drmaranon.com/procedures/jaw-surgery/what-to-expect-after-surgery/. 
11. Fricton, James. “Are Oral Appliances Effective for Treating Sleep Apnea?” Minnesota Head & Neck Pain Clinic, MN Head and Neck Pain Clinic, 6 Jan. 2022, mhnpc.com/2022/01/06/effective-oral-appliances-for-treating-sleep-apnea/.
12. Blum, Dani. “F.D.A. Approves Weight-Loss Drug to Treat Sleep Apnea.” The New York Times, 20 Dec. 2024, nytimes.com/2024/12/20/well/zepbound-sleep-apnea.html.
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14. Brzostowicki, David. “New Drug Offers Hope for CPAP-Free Nights for Sleep Apnea.” WebMD, 30 May 2024, webmd.com/sleep-disorders/sleep-apnea/news/20240530/new-drug-offers-hope-for-cpap-free-nights-for-sleep-apnea.
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16. Kundu, Kaustav, and Lokesh Kumar Saini. “Novel Wearable Devices for Screening Obstructive Sleep Apnea.” Sleep and Vigilance, vol. 8, no. 1, 13 June 2024, pp. 1–2, doi.org/10.1007/s41782-024-00275-6.

R. Kirk Huntsman, Chairman, CEO, and Co-founder of Vivos Therapeutics, is a distinguished leader in the dental and healthcare industries, renowned for founding and growing successful dental service organizations (DSOs). In 1995, he founded Dental One, expanding it to over 165 practices across 15 states before its sale in 2008. He later led ReachOut Healthcare America, a Morgan Stanley Private Equity portfolio company, and established both Xenith Practices and Ortho Ventures. Since 2016, Kirk has served as CEO and chairman of Vivos, driving advancements in dental technology. As a founding member of the Association of Dental Support Organizations (ADSO), he continues to shape the industry’s future.