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). 8 FLORIDA MD - MARCH/APRIL 2022
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).
