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

Eligibility 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
• * • 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