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