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