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 theBrodsky 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 theduration 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-obstructivesleep-disordered breathing (e.g., central sleep apnea, hypoventilation,and sleep-related hypoxemia). Examples of such conditions includesignificant cardiopulmonary disease, potential respiratory musclesweakness due to neuromuscular conditions, history of stroke, and chronicopiate medication use.

• Concern for significant non-respiratory sleep disorder(s) that requireevaluation (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 acquisitionand 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 meannocturnal 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 legssyndrome, 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 asuvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), ortongue/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 couldalter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoidsuspension)

• 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 pressuredespite therapy with ≥ 3 oral hypertensive agents

• Presence of congestive heart failure (NYHA Class IV), persistent/permanentatrial fibrillation, or acute coronary artery disease (STEMI/NSTEMI/USA) in thepast 30 days.

• Presence of neuromuscular diseases e.g. myasthenia gravis, amyotrophic lateralsclerosis, Guillain-Barré syndrome and muscular dystrophy, or hypoventilationdisorders which results in shallow breathing during sleep and/or cyanosis ofthe fingers/toes.

• Presence of pulmonary disease resulting in significant desaturation, e.g.,severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2nadir 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