Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea

Inclusion Criteria: * • Provision of signed and dated informed consent form * Unable to tolerate or decline positive airway pressure therapy * Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification * Able to protrude tongue ≥20mm beyond maxillary incisors * No uncontrolled nasal obstruction (must be able to breathe through nose) * Stable medication regimen for ≥1 month * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, of any race, aged 18-70 years (inclusive) * If diagnosed with uncomplicated Mild to moderate, moderate to severe OSA (i.e., AHI \>5, \<30 h-1); where uncomplicated is defined by the absence of: * Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use. * Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia). * Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT. * Body mass index (BMI) \< 35 kg/m2 * Neck circumference \< 45 cm * Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 82% * Mandibular range of motion \> 5 mm in protrusive direction * Adequate dentition, as determined by the site dentist * Must have a smart phone able to download 02 ring app Exclusion Criteria: * • Inability to breathe through the nose comfortably * Presence of \> 25% Central Sleep Apnea (CSA) * Severe OSA above AHI \>40 * Uncontrolled sleep disorder such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder * Presence of positional obstructive sleep apnea per Cartwright's definition (Ratio of respiratory events in the supine to nonsupine position greater than 2:1) * History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension. * History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy within the previous 6 months * Presence of hypoglossal nerve stimulation device * Use of CPAP or OAT within the two weeks prior to the screening HSAT * Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension) * Loose teeth or advanced periodontal disease * Teeth extractions/Presence of a dental post implanted less than 12 months * Removable dentures * History of temporomandibular joint disorder (TMJ) * Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents * Presence of congestive heart failure (NYHA Class IV), persistent/permanent atrial fibrillation, or acute coronary artery disease (STEMI/NSTEMI/USA) in the past 30 days. * Presence of neuromuscular diseases e.g. myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome and muscular dystrophy, or hypoventilation disorders which results in shallow breathing during sleep and/or cyanosis of the fingers/toes. * Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension * History of cerebrovascular incident within the last 12 months * Use of pacemaker or other life supporting device * Anticipated change in body weight \> 5% during the study period * Participation in other studies that could interfere with the study protocol