PULMONARY

What’s New in the Treatment of Mild Obstructive Sleep Apnea and Primary Snoring?

By Tabarak Qureshi, MD FCCP

THE FIRST FDA-AUTHORIZED DAYTIME THERAPY: EXCITEOSA® SNORE... SNORE… SNORE…

We all know of someone who snores, but when people are informed of their snoring, the typical response is denial and disbelief. The truth of the matter is that snoring is extremely common, but most people don’t understand why it happens.

Snoring is generated when the upper airway/pharyngeal muscles relax and as air flows through a relaxed posterior airway. In some people with a crowded posterior airway, these sounds and vibrations result in mild obstructive sleep apnea (OSA), which is identified by having an AHI (apnea hypopnea index) between 5-15 events/hour. The repeated airway obstructions result in sleep disruption, blood pressure swings, and recurrent nocturnal asphyxia and hypoxia resulting in increased sympathetic nervous system activation during sleep. Traditionally, there has not been any significant treatment modality for primary snoring. Mild OSA has been treated primarily with auto-CPAP/PAP or mandibular advancement devices along with lifestyle modifications (weight loss, drinking, and smoking cessation). The most notable change is noted in the upper airway and the genioglossus muscle. This collapsibility is higher in mild OSA compared to primary snoring. In non-snorers, there is an ability to prevent collapsibility of the upper airway and have functional mechanisms that prevent collapse.

The genioglossus is considered the largest muscle of the airway and the most important dilatory muscles during sleep onset. With sleep onset, there is rapid reduction in pharyngeal and tongue muscle contractility. Over time the respiratory stimulus and genioglossus activity progressively increase during stable non-REM sleep. However, a notable number of individuals fail to effectively increase genioglossus activity or achieve inadequate tongue muscle activation to overcome the obstruction prior to the arousal. Therefore, there is a failure of the tongue muscles to generate an appropriate protective response from a neural drive or responsiveness perspective.

The first proof of concept of daytime stimulation of the tongue was presented by Wiltfang in 1999 (28). He demonstrated using a TENS like stimulation during daytime for two weeks resulted in a significantly reduced respiratory disturbance index (RDI), from 13.2/hour to 3.9/hour, oxygen desaturation index improved as did minimum oxygen saturation from 75% to 88%. In another prospective placebo controlled randomized trial of daytime tongue stimulation vs TENS type stimulation the number of snoring epochs decreased significantly (from 63.9±23.1 epochs per hour to 47.5±31.2; P<.05). EXCITEOSA®:

The eXciteOSA device targets the intrinsic and extrinsic pharyngeal and tongue muscles by delivering neuromuscular electrical stimulation to the tongue with the purpose of increasing muscle responsiveness and preventing excessive relaxation. The device has three components: 1. Washable flexible electrode mouthpiece with an electrode array that fits onto the tongue. 2. Rechargeable control unit that attaches to the mouthpiece via a USB connection. 3. Smartphone App that manages the functions of the device.

The mouthpiece is placed in the mouth, on the tongue with the two electrodes located above and two below the tongue. Therapy consists of a series of pulse bursts with rest periods for 20 minutes during the wakefulness state for a period of 6 weeks. With daily use of eXciteOSA, the tongue muscle function improves to prevent the backward collapse of the tongue and hence obstruction of the airway. CLINICAL TRIALS DATA

The original trial was a prospective multicenter trial of individuals with primary snoring or mild OSA. Snoring was assessed by the bed partner reporting on a visual analog scale-VAS (ranging from 1-10, 10=unbearable snoring). The snorers sleep quality was recording using the Pittsburgh Sleep Quality Index (PSQI) pretreatment (2 weeks before start of therapy), during treatment phase (6 weeks recorded in last two weeks) and post treatment (2 weeks after stopping therapy). 27 individuals completed the trial (8 women and 19 men), average age 44 years (age range 2568 years), BMI 29.7 (range 20.7-35) and AHI 9 (range 2.5-15).

Eight primary snorers and 19 had mild OSA.

Results revealed bed partner reported snoring reduced by 52% (p<0.001) with over 80% declaring a reduction of >40%. The change remained statically significant for primary snores and mild OSA patients (VAS reduction 6.6 to 3.6 p<0,001).

Another multicenter clinical trial was undertaken at London University hospital along with other sites in Europe. The objective was to validate the objective measures and assess the reproducibility of the subjective outcomes of the previous study. This was cohort of mild OSA (HST using WatchPAT®) and primary snorers. Two consecutive night studies were conducted before and after the 6-week period. This was supplemented with partner VAS, Epworth Sleepiness Scale (ESS), and PSQI. 125 patients were recruited and 115 (50 primary snorers and 65 mild OSA patients) completed the trial. The average age was 46 (range 24-79 years), 73 males and 42 females, average BMI 27 (range 20-34). For the study population the mean objective percentage of sleep time snoring at >40dB, reduced significantly by 41% (p<0.001). 90% of the participants recorded an objective reduction in their snoring. Clinically significant reduction in snoring time was also reported at snoring intensities of 45dB and 50dB with an improvement of 52% (p<0.001) and 54% (p<0.001) respectively. In mild OSA, 79% showed an average reduction in AHI of 52% (p<0.001) and the post therapy AHI normalized to 4.95. Statistically significant improvements were noted in ESS and PSQI scores as well (p<0.001).

Oral pooling of saliva was most common side effect, with a

small percentage reported tongue discomfort, tooth discomfort, filling sensitivity, gagging, metallic taste and jaw tightness. Prevalence of these symptoms reduced in the six weeks of therapy. DISCUSSION AND CONCLUSION

Daytime neuromuscular electrical stimulation (NMES) therapy for correction of nighttime airway obstruction is a novel, innovative and probably unconventional therapeutic strategy. The ability to control nighttime sleep disordered breathing without wearing a nighttime device makes this an attractive treatment modality. NMES involves the application of electrical current to induce muscle contractions and has been shown to activate the muscle to a greater extent than voluntary muscle actions. It has been known to activate motor units that are not otherwise activated. NMES has been shown to change the myofibrillar protein expression to induce a phenotype shift from fatigue prone to fatigue resistant with the strengthening of the cytoskeleton. NMES has been shown to result in metabolic shift from glycolytic to oxidative profiles, increasing intracellular defense against harmful oxygen species, reverse the degeneration of pre and postsynaptic tongue neural morphology associated with ageing and a shift to a higher contractile tension. eXciteOSA offers a simple and effective method of addressing the above-mentioned process and has been shown to benefit individuals with primary snoring and mild OSA. eXciteOSA provides a targeted retraining tool to stimulate the tongue and the biggest dilatory muscle of the airway – the genioglossus muscle. The clinical trial demonstrated significant reductions in all of the relevant objective measures, 90% of the study population showed reduction in snoring, 79% of the mild OSA population showed a 50% reduction in AHI and ODI resulting in reduction in ESS and PSQI.

Tongue muscle training using eXciteOSA has proven to be effective in reducing multiple indices associated with sleep disordered breathing. Additional studies have been published and accepted for publication and currently underway. eXciteOSA provides a “no nighttime wearable” safe option of therapy for patients and overcomes many of the risks and disadvantages of currently available treatment options.

For more information on this novel daytime therapy option, visit the eXciteOSA website: eXciteOSA.com or email info@signifiermedical.com.

Bibliography available upon request.

Tabarak Qureshi, MD FCCP practices at Central Florida Pulmonary Group. He is Chairman-Division of Pulmonary Medicine at AdventHealth, Director of ICU AdventHealth Altamonte Springs and Director of the Sleep Lab

at Central Florida Pulmonary Group. 

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When Scoliosis Requires Treatment

By José Herrera-Soto, MD ABOUT SCOLIOSIS

Scoliosis affects an estimated 2 to 3 percent of the U.S. population, both children and adults. But because scoliosis tends to progress as a child develops, this abnormal C- or S-shaped curvature of the spine is most often diagnosed in children between the ages of 10 and 15. A vast majority of cases, up to 85 percent, are classified as idiopathic, and less than 10 percent of children experience any back pain or other symptoms. In fact, it is often during a routine physical exam or Adam’s forward bend test that a spine curvature or rib hump is discovered.

Scoliosis tends to be passed down to children through genetics. Although parents may not have had scoliosis as a child, it may have occurred in other family members or gone undiagnosed. Whether a documented family history of scoliosis is present or not, a child having scoliosis is no one’s fault; scoliosis itself is not preventable.

The biggest risk associated with scoliosis is significant curve progression over time. Referral to a specialist ensures a full orthopedic and neurologic evaluation as well as diagnostic imaging tests to determine the exact location and extent of the curvature in order to develop a customized treatment plan. With about 1,800 visits in 2019, the Scoliosis Center at Orlando Health Arnold Palmer Hospital for Children cares for children across the full scoliosis spectrum, including idiopathic, congenital, neuromuscular and syndromic scoliosis from early-onset to adolescent diagnoses. TREATMENT THERAPIES

Only a small percentage of children with scoliosis — about 30 percent — will require treatment such as physical therapy or bracing, and an even smaller number — about 10 percent — will require surgery. The standard determination of severity in scoliosis is measured in terms of the degree of curvature. Spinal curves measuring less than 25 degrees generally do not require treatment. For these patients, ongoing observation with regular checkups is recommended to watch for any progression of disease.

If the curvature increases over time or presents at 25-45 degrees, nonsurgical treatment encompassing physical therapy, bracing and casting options — used individually or in combination — can help to slow or prevent disease progression. A growing child often can overcome minor spinal curvatures and deformities through these less invasive options; for major deformities, these treatments provide ongoing care until the child is older and showing signs of skeletal maturity needed for surgery.

The Schroth Method is a relatively new type of physical therapy, which began in Germany and has continued to develop as its use around the world has grown. The Scoliosis Center at Orlando Health Arnold Palmer is one of the few centers in Florida that has a specialist trained in this unique treatment option. The Schroth Method focuses on customized posture, positioning and breathing exercises, as well as on activities of daily living and self-image, and is often used in conjunction with bracing. Some studies have found that this treatment option has a positive effect on a child’s sense of well-being and perception of curve improvement, leading to better patient engagement and thus, better outcomes.

If a patient is still skeletally immature but has progressed to a point that physical therapy and/or bracing is ineffective, growing rods become the next course of treatment. Conventional growing rods are surgically inserted either in the lumbar spine or ribs, based on the type of instrumentation used, or a hybrid. Proven to be a very effective treatment, the growing rods are surgically changed or lengthened approximately every six months. Some patients may benefit from a system called MAGEC® (MAGnetic Expansion Control), which utilizes innovative magnet technology. Once the adjustable growing rods are surgically inserted, the lengthening can be done as an in-office procedure using an external remote controller to operate a motor inside the rods to lengthen them as needed. This method can be especially effective for debilitated or very weak patients, reducing the potential risks of repetitive surgeries and anesthesia.

When the angle of curvature is more than 50 degrees, surgical correction is recommended, as studies have shown that deformity over 50 degrees will continue progressing. Spinal fusion is a major surgery, performed to correct the curvature permanently. Hooks or screws are placed into the vertebral column, which are then attached to rods that are maneuvered and rotated to straighten the spine. Orlando Health Arnold Palmer performs about 150 spinal surgeries annually, providing patients with a more functional spine and symptom relief. A multidisciplinary approach includes a dedicated team of specialists utilizing advanced technology, such as spinal cord monitoring and fluoroscopy to aid in the placement of instruments and devices. Ongoing follow up with the patient occurs every six months or yearly, depending on the age and the degree of severity.

A NEW SURGICAL TREND

Orlando Health Arnold Palmer also will soon be participating in a study of a new procedure known as vertebral body tethering (VBT), becoming one of only a handful of centers in Florida to offer this surgical option. Guided by very specific indications of bone maturity and curvature, this procedure harnesses the growth potential on the concavity of the spine while holding or limiting the growth on the convexity. So, as the concavity catches up with convexity in height, the spine straightens. With access through a minimal incision in the chest, anchors are placed on the front of the spine, anchoring the growth centers. But because it is not a fusion, the spine can continue to move in a

THE TAKEAWAY

When a child is diagnosed with scoliosis, many parents are understandably worried about how this diagnosis will affect their child’s health and future. This type of response is normal. Referral to a specialty center to learn more about the science behind scoliosis and its treatments can help patients and families feel less anxious. While scoliosis requires monitoring with a specialist and — depending on its severity — possible life adjustments, it is a manageable condition with positive outcomes, with kids able to compete in sports, play with their friends and enjoy a fun, carefree childhood.

José Herrera-Soto, MD, is a pediatric orthopedic surgeon at Orlando Health Arnold Palmer Hospital for Children. Board

certified in orthopedic surgery, Dr. Herrera-Soto sees patients at the Orlando Health Arnold Palmer Center for Orthopedics.

He specializes in treating congenital, neuromuscular and idiopathic scoliosis, kyphosis and other spinal conditions as well as

hip preservation surgery and hip conditions. He is also involved in the design and development of implants for the correction

of spinal deformities. Dr. Herrera-Soto earned his medical education from the University of Puerto Rico School of Medicine.

He also completed his residency at the University of Puerto Rico and a fellowship in pediatric orthopedic surgery at Cincin-

nati Children’s Hospital Medical Center. 

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