Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

Inclusion criteria

• Adults (≥ 22 years)
• Self-report of daytime somnolence
• Body mass index (BMI) ≤ 32
• Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
• Evidence of palate and tongue base collapse on supine fiberoptic examination
• Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (< 4 hours per night by patient report)
• No prior surgical treatment for OSAS other than nasal surgery
• Willing and capable of providing informed consent

Exclusion criteria

• Another significant sleep disorder (e.g., insomnia, periodic limb movement)
• Tonsillar hypertrophy
• Chronic Obstructive Pulmonary Disease (COPD)
• Interstitial Lung Disease (ILD)
• Cystic Fibrosis
• Acute Repiratory Distress Syndrome (ARDS)
• Nasal or supraglottic obstruction on fiberoptic examination
• American Society of Anesthesiologists (ASA) class III ,IV, V
• Latex allergy
• Lidocaine allergy
• Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.
• Major depression or non-stabilized psychiatric disorder
• Drug or alcohol abuse
• Previous palatal or tongue surgery
• Stable or unstable angina
• congestive heart failure (CHF)
• moderate or severe valvular disease
• transient ischemic attack (TIA)/cardiovascular accident (CVA)
• Carotid stenosis or endarterectomy
• Anemia
• Room air oxygen saturation (SpO2) < 95%
• Pulmonary hypertension
• Dialysis
• Central or mixed apnea ≥ 10% of respiratory events
• Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study