Pivotal Study of the iNAP® in Adults With OSA

A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)

A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.

Inclusion Criteria:

• Patients able to read and sign on the informed consent form and able to comply with study requirements.
• Body mass index (BMI) <33 kg/m2
• AHI between 15~55
• Pass a device feasibility test

Exclusion Criteria:

• Obstructed nasal passages
• Hypoxemia (SpO2 <80%)
• Primary insomnia or other suspected sleep disorder other than OSA
• Muscle diseases, e.g. CSA
• Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients