Are We Truly Open to Change in the Approach to OSA?

Although there are more than half a billion individuals worldwide affected by moderate to severe obstructive sleep apnea (OSA), the vast majority still remain undiagnosed and many are untreated.^1-2 Healthcare in the United States is facing shortages at every level—and these shortages are projected to increase sharply over the next decade.³ This is reflected in our own field with shortages of sleep medicine providers and sleep technologists.

We are also recognizing the inequities that our healthcare system and research efforts have fostered. Fortunately, we live in a time where innovative methods of practice are making the path to diagnosis and therapy much faster, easier, and cost-effective.

Tackling the difficult issues our field is facing requires an acceptance of change at a much more rapid pace than we have historically taken to address those with untreated or under-treated OSA.

One of the intriguing challenges in our field is the incredibly fractured path to diagnosis and treatment. Not only are the paths deleterious to our patients, but truly daunting for providers as well. To combat this, we must be willing to embrace change in the form of the innovations that are now available.

Embracing Digital Innovation

One of the most important aspects of innovation involves utilizing digital platforms that can improve our organizational ability to navigate the path to diagnosis and care. Artificial intelligence (AI) and machine learning hold the keys to streamlining processes that keep our practices bogged down. Consider polysomnography scoring and clinical practice workflows as two examples of how AI could improve OSA care paths.^4-5

The 5 V’s of Big Data—volume, velocity, veracity, variety, and value—are allowing us to redesign clinical trials to look at those questions that have been traditionally difficult to answer without large and cost-prohibitive clinical trials.⁶ If we can utilize Big Data for both research and guidance of clinical practice, we can turn our focus to a value-based care model that combats the inequities that healthcare has struggled with to date. It does require relinquishing current misconceptions by embracing educational endeavors. A historical comparison can be made to the initial attitude toward calculators, demonstrated by math professors who formally protested the use of calculators by students.⁷

In the realm of diagnostics, we previously utilized methods that are cumbersome, expensive, and have prolonged the path to care. Diagnosis of sleep apnea has gone from in-lab diagnostic testing for all suspected of having the disorder, to home sleep apnea testing (HSAT) with traditional flow-based monitoring. More recently, peripheral arterial monitoring has come to the forefront of HSAT after a prolonged time to accept its use. With the growth of remote patient monitoring (RPM) and the recent FDA approval of photoplethysmography (PPG) powered by AI, we are finding ways to increase access to care through smaller, less cumbersome devices.⁸ The analysis of signals that we have been acquiring for many years—but are now analyzing in a different manner—is allowing us to use smaller, more streamlined devices to diagnose sleep apnea.

In the realm of therapeutics for OSA, we now can approach our patients with precision based on endotypes and phenotypes. Danny Eckert, PhD, a leading researcher and sleep and respiratory physiologist, has performed elegant studies in his research lab delineating various endotypes of obstructive breathing beyond airway collapsibility to include pharyngeal muscle dysfunction, high loop gain, and reduced arousal thresholds.⁹ In the clinical setting, there are several published studies delineating phenotypes of patients with resultant therapeutic implications, based on history, physical assessment, diagnostic testing parameters, and co-morbidity cluster analysis from data mining the electronic health record.^10-11

Expanding Options

Let’s look at the therapies for OSA, keeping in mind that combining options and re-evaluating the patient and their motivations at regular intervals is key. We’ll start with behavioral modifications and positional therapy, as they can be added to all other forms of therapy to boost efficacy and potentially adherence. These are also the adjunct therapies that are often either ignored or mentioned in a superficial manner with patients.

Behavioral modification is central and important to utilize in combination with all other forms of therapy. Maintenance of ideal body weight is key in reducing the apnea hypopnea index (AHI) as much as possible to increase the success of other treatment modalities. The use of the Mediterranean diet was shown in the MIMOSA trial to ameliorate the hypoxic burden of OSA.¹² Medications available for weight loss have shown their ability to reduce AHI and respiratory disturbance index (RDI) in clinical trials.¹³

Positional therapy is one of the most beneficial and easily tolerated forms of therapy that can be utilized in combination with positive airway pressure (PAP), oral appliance therapy (OAT), surgery, weight loss, and hypoglossal nerve stimulation. There are a variety of devices that can be applied to assist in avoidance of supine sleep, with the Centers for Medicare and Medicaid Services (CMS) having recently approved coverage of a device that is a positional trainer monitoring efficacy and adherence.¹⁴

In exploring PAP alternatives in the treatment of OSA, the utilization of drug- induced sleep endoscopy (DISE) can be a powerful tool when used early to assist in treatment decision-making.¹⁵ Oral appliance therapy is a treatment option that is commonly used, both alone and in combination with other therapies, historically for mild to moderate apnea. However, there is a role for the use of OAT in specific patient populations with severe apnea.¹⁶ OAT manufacturing is moving toward technology embedded within devices to monitor efficacy and adherence.

There have been recent developments in the use of oral medications for the treatment of sleep apnea—with the most prominent being the use of atomoxetine-oxybutynin in combination, which has been shown in the literature to reduce AHI and hypoxic burden. The mechanism of actions includes an increase in pharyngeal muscle tone and increased ventilatory drive.¹⁷

Surgery can also be considered as part of the regimen, based on phenotype. Trials have shown reduction of AHI and sleepiness with multi-level surgery in those with moderate to severe OSA, while computer modeling has been found to guide surgical intervention.^18-19 Hypoglossal nerve stimulation devices have shown efficacy by reduction in AHI and ESS as well as increased adherence compared with other therapies.²⁰

PAP therapy is very effective in resolution of airway collapse, hypoxemia, and reduction in hypoventilation.²¹ The pain points are the complex path to treatment, patient adherence, and the difficulty in proving long-term cardiovascular benefit from the use of PAP.

In a recent retrospective analysis of more than 86,000 patients who underwent testing for OSA, of those diagnosed with OSA, only 60.8% were set up on CPAP in the first 12 months, and just 4% were treated with an oral appliance. One might ask about the balance of those diagnosed, and presume they are not treated. There were also prolonged periods of time between diagnosis and the time of therapy.²²

Recent data from CMS shows that once they have been set up on PAP therapy, 72.6% of patients are considered adherent by CMS criteria at 90 days—but there is a rapid decline after that period, resulting in overall non-adherence of 30% to 40% over time.^23-24 There are several innovations that are targeting the barriers to effective PAP therapy.

Robust adherence platforms powered by AI are analyzing and monitoring patient adherence data, allowing us to prioritize our efforts on patients in need with laser focus.⁵ Digital platforms that streamline PAP ordering and setup decrease the time to set up and reduce the pain points providers face when prescribing PAP therapy. Utilizing facial imaging from a device allows better PAP interface choices and has the potential to increase overall adherence. There is also a device available that decreases PAP pressure on inspiration, making therapy more comfortable while reducing overall pressure exposure.

One of the most exciting developments in the last decade has been the Certification in Clinical Sleep Health (CCSH): a credential that validates healthcare providers and educators to work with sleep patients and their families. This addition to the workforce promises to address many of the barriers faced by patients and providers in treating OSA, particularly with PAP therapy.

Conclusion

A plethora of innovations are at our disposal for the diagnosis and treatment of OSA including digital platforms, AI, machine learning, automated scoring, new devices, medications, new credentials, and processes. It does require eliminating the silos between specialties, and the creation of partnerships with those in manufacturing, technological, and pharmaceutical fields.

There is no shortage of patients or lack of combinations of modalities to improve where we currently stand for the best treatment practices for OSA. However, it does require a willingness to explore these modalities for the benefit of our patients.

By Colleen G. Lance, MD

Source: SleepWorld Magazine May/Jun 2024 Issue

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