Background

If the Healthcare industry is going to address the cost of Chronic Disease, Obstructive Sleep Apnea (OSA) must be effectively treated. OSA has an extremely high clinically proven correlation (comorbidity) with heart disease, atrial fibrillation, stroke, diabetes, hypertension and obesity, making it one of the most devastating untreated diseases currently faced by the medical community.

The major precipitating factors are the aging population, and more importantly, the rapidly increasing incidence of obesity within the overall population. The underlying problem is that Primary Care Physicians and dentists see millions of patients every day, yet over 85% remain undiagnosed because they are not screened for OSA.

Number of Undiagnosed Doubled in Ten Years

Unlike ten years ago, the Medical and Dental Community recognize the problem, and are anxious to address OSA. Third Party Payors also now understand the cost of leaving the disease untreated and universally pay for OSA care. However, despite the awareness of the problem, the willingness to reimburse, and the presence of diagnostic and therapeutic products that work, the healthcare system is losing ground in the fight.

OSA is a chronic disorder, characterized by repetitive stops and starts in breathing during a night of sleep. As muscles in the throat relax, a partial (hypopnea) or complete (apnea) blockage of the airway occurs, leading to symptoms such as snoring, gasping or choking. The Patient struggles to breath, forcing them to awake and take action to relieve the obstruction. Breathing resumes, oxygen levels increase, carbon dioxide is reduced, and the Patient resumes sleep. This cycle can occur several dozen times per hour, which severely insults the central nervous system and results in many comorbidities over time.

Comorbidities

OSA has an extremely high clinically proven correlation (comorbidity) with heart disease, stroke, diabetes, hypertension, obesity, ocular disorders (such as glaucoma), memory and cognitive problems, and depression, making it one of the most devastating untreated diseases currently faced by the medical community. Chronic conditions are the leading cause of death and disability¹,  and treating patients with comorbid conditions costs up to seven times as much as treating patients with only one chronic condition². The comorbidities associated with untreated OSA cost over $130 billion per year, making diagnosis and treatment the most cost justified expense in healthcare.

Responsive to Treatment

There is substantial clinical documentation showing that the treatment of OSA has a rapid, positive impact on comorbidities:

• Daytime blood pressure, heart rate, and left ventricular function improve
  within one month of treatment;
• Risk of stroke is reduced by 35%, and coronary heart failure by 20%;
• Blood glucose levels are improved; and
• Blood pressure is reduced by an amount which equates to a 20% reduction in cardiovascular risk.

Treatment is Sound Economics

There are many studies documenting large healthcare cost reductions resulting from treatment. One study by Kryger et al, compared one group of OSA patients undergoing treatment with one that did not. It showed that expenditures for physician care were reduced by 50%, and the hospitalization days were reduced by a dramatic 64%.

Two additional studies in the transportation industry showed similar results. Schneider Trucking compared a single group of patients, both pre and post diagnosis. They found a healthcare cost reduction of 48% after the individuals were under treatment for OSA. Waste Management directly compared healthcare costs for treated vs. untreated OSA patients and found that the second year medical costs for those being treated were reduced by 41%. Adding disability costs, the two-year healthcare savings for the treated group was over $6,000 per driver.

Diagnosis

Screening and Assessment
A multistep approach is taken to diagnose OSA. It all begins with a screening questionnaire that collects OSA relevant medical history and answers to symptomatic questions. For a current practice patient, it can be taken online through a provider linked website or in the office through a digital input device such as an electronic tablet. Alternatively, consumer can access the screening survey at mysleepsurvey.com.
Based on the results, it can be determined if further evaluation is required. If the patient is positive to the screen, they will be directed to a provider, who will review the screening questionnaire and complete a final and actionable Assessment. As part of a comprehensive clinical evaluation in a patient suspected of OSA, various measurements may be utilized to evaluate symptoms and rate the likelihood that symptoms represent OSA.
The most common instruments evaluate daytime sleepiness, snoring, blood pressure, and fatigue and fatigue symptoms, as well as demographic and anatomic information. Commonly used measurements include the Epworth Sleepiness Scale (ESS), the STOP and BANG, all of which are included in ProAct’s proprietary Assessment. Based on the Assessment, a decision to proceed with a sleep test can be made.

Epworth Score Explained

The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness. Depending on the comorbidities, a score of 11 or more is often required by most Payors to justify reimbursement for a Home Sleep Test (HST), unless there is a positive result on Witness Apnea Assessment Question, in which case an HST is immediately justified.
In addition to the Epworth questionnaire, several other evaluation tools may be employed for initial OSA assessment. These tools include the STOP and BANG questionnaires, with STOP-BANG often used together for Dental and pre-Surgery patients.

STOP Score Explained (Snore, Tired, Obstruction, Pressure)

This simple 4 question tool provides a quick guide for diagnosis. Patients tend to have a low risk of OSA if affirmative answers are ≤1, and a high risk of Sleep Disordered Breathing (SDB) if the affirmative answers are ≥2.

BANG Score Explained (BMI, Age, Neck, Gender)

Patients tend to have a low risk of OSA if there is only 1, or zero, affirmative answer. This extension to the STOP questions provides additional accuracy to screening for OSA. Affirmative answers to 3 or more of the combined STOP-BANG questions indicate a high risk of OSA.

Following initial assessment, patients judged to be at risk of having OSA can undergo objective sleep testing to measure the Apnea-Hypopnea Index (AHI): the sum of the number of apneas and hypopneas divided by the total hours of sleep. Apneas are complete disruptions in breathing that are greater than 10 seconds.  Hypopneas are defined as a 50+% reduction in breathing lasting longer than 10 seconds.

Sleep Testing

There are two ways to test patients in order to collect data that will enable a Certified Sleep Specialist to complete the diagnosis and treatment recommendation: 1) a Sleep Lab based Study or Polysomnogram (PSG), or 2) a Home Sleep Test (HST). Unfortunately, deeply embedded paradigms and a general lack of awareness on the part of many have created a situation where historically 97% were completed with a Polysomnogram ($2,000-$5,000) and only 3% by HST ($500-700). However, that trend is rapidly changing toward HST due to cost pressures.

Sleep Labs: Polysomnography (PSG)

A full-night sleep evaluation conducted in an accredited sleep facility and attended by a certified sleep technician is the historical norm for objective confirmation of OSA. Several “channels” (i.e. measurements of objective clinical parameters) are required during a PSG: cardiac activity (via ECG), brain activity (via EEG), visual movements (via electrooculogram), muscle activity (via electromyogram), airflow rate, oxygenation, respiratory movement, and body position. The measurement and clinical documentation of these physical parameters provides data to calculate the AHI and/or RDI by an experienced, board-certified clinician. Patients spend an entire night undergoing evaluation of their sleep and breathing patterns during the PSG. Split-night testing may be undertaken in patients with a confirmed OSA diagnosis in the initial 2 hours of the PSG; following documentation of the AHI, a positive airway pressure treatment device (CPAP) titration is conducted during the remaining hours.

Convenient and Economical

Home Sleep Testing (HST)

A large majority of patients (90+%) can be diagnosed in the comfort of their own home with an inexpensive Home Sleep Test, which gathers all of the required data to allow the Sleep Specialist to complete the diagnosis. The amount of clinical data collected with various monitors differ: the American Association of Sleep Medicine (AASM) recommends that at a minimum, airflow (apneas hypopneas), blood oxygenation, and respiratory effort should be recorded. ProAct utilizes the CleveMed Home Sleep Testing Device which measures the same criteria as recommended by the AASM plus snoring and sleep position.

Treatment

The Certified Sleep Specialist will make a treatment recommendation based on the testing results, combined with a review of other medical conditions. There are currently three reimbursed treatment options available to alleviate obstruction of the airway: Positive Air Pressure (PAP) devices, Oral Appliance therapy (OAT), and, in very rare situations, surgery. After consideration of lifestyle changes such as weight loss, smoking cessation and decreased alcohol consumption, today’s first-line therapy typically involves positive airway pressure (PAP) devices. For patients who do not respond to PAP, alternate approaches include dental appliances and surgery to alter the obstructive anatomy.

Again, this is due largely to deeply embedded paradigms and a general lack of awareness on the part of many; over 50% do not tolerate a PAP and they usually fall out of treatment. It is clinically proven that 70% of OSA patients could/should be treated by OAT as the first course of treatment.  OAT is proven to be tolerated by over 90% of patients.

Compliance is Critical

Positive Airway Pressure (PAP)

PAP involves the administration of pressurized air to a patient through a mask in order to keep the airway fully open during inhalation and exhalation. A titration process is undertaken to arrive at the maximum effective pressure tolerated comfortably by the patient. Common side effects include claustrophobia, along with nasal and oral dryness, which contributes to the poor therapy compliance. Several modifications exist to decrease side effects of PAP such as heated humidification to combat dryness, and alternate modalities like auto-titrating PAP (APAP), bi-level PAP (BPAP) or variable PAP (VPAP). In patients who require very high pressures, these alternate modalities provide different inspiratory and expiratory pressures, which may increase tolerance as well as therapy compliance. Treatment with PAP is long-term with annual evaluation to assess therapy response, compliance, and any equipment adjustments required.

Oral Appliance Therapy (OAT)

Oral devices, custom-fitted by dentists trained in their use may be used to treat patients with mild-to-moderate OSA. OAT is the most prescribed form of oral appliances and should also be used in patients intolerant to PAP therapy. These devices work by advancing the lower jaw, thereby increasing the airway space during sleep. Annual appointments and periodic sleep testing are recommended following initial titration to evaluate continued successful management of OSA.

Surgical Procedures

Reserved predominantly for patients with moderate-to-severe OSA who have failed PAP therapy, surgical techniques designed to alter the anatomic space of the mouth and throat are also potential treatment options. Other common invasive procedures include uvulopalatopharyngoplasty (UPPP), in which the soft palate and surrounding tissue in the back of the mouth are removed to relieve airway obstruction, and maxillomandibular advancement (MMA), in which the upper and lower jaws are repositioned.

Following surgery, some patients may continue to require PAP therapy to effectively manage the symptoms of OSA. In addition to side effects that may occur with any surgical procedures (anesthesia risks, bleeding, infection risk and sudden death), other potential side effects of OSA surgery include speech or swallowing problems, taste alteration, and transient nerve paralysis.

In summary, ProAct believes the surgical approaches are not viable alternatives due to the high risks, intensive pain, long recovery, uncertain outcomes, and high costs.

Other Approaches

There are other devices and treatment alternatives in clinical study; however none have been proven sufficiently to gain Payor reimbursement. When these become viable treatments, ProAct will be in a position to offer them if our patients and providers want to use them.

Weight Loss Interventions

Excessive weight is a serious issue with many OSA patients. In many cases it is difficult to determine what came first, OSA or weight gain. It has been clinically documented that OSA causes hormonal changes that reduce the hormone that suppresses appetite and increases the hormone that increases appetite. However, many people became heavy before they developed OSA. Undoubtedly, weight loss will improve many patients with OSA but the general consensus is that the majority of the patients will be more successful losing weight if their OSA is treated. Exercise alone may impact patients with OSA by decreasing the AHI and improving sleep quality. Following significant weight loss (≥ 10% of body weight), patients should be reassessed for OSA.