NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients

Inclusion criteria

• Capacity and willingness to sign consent
• Patient willingness to commit to and complete study over a 30-day time period
• Confirmed diagnosis of moderate to severe OSA (AHI >= 15)
• OSA caused by upper airway obstruction
• CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
• Adequate manual dexterity to demonstrate ability to self-insert and remove device

Exclusion criteria

• Within 3 months of initiating CPAP use, and actively using CPAP
• Supraglottic airway collapse
• Distal airway stenosis
• Tracheobronchomalacia
• Currently pregnant
• Active COVID-19 infection
• Need for anticoagulative therapy
• Severe nasal allergies
• Bleeding disorder
• More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time
• Restrictive thoracic disorders
• Silicone, lidocaine, neosynephrine allergy
• Recurrent epistaxis
• Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure