Mouth device for obstructive sleep apnea, checked for safety and sleep improvement

Who can take part

• • 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

Who cannot take part

• • 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