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

NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients

This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.

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