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

Not Applicable

Completed

Brief Summary: The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.

This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
RFA treatment	RFA treatment	RFA treatment performed with CelonProSleep plus device

Primary Outcome Measures

Name	Time	Method
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline	6 months following last treatment	The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.

Secondary Outcome Measures

Name	Time	Method

Locations (6): Methodist Healthcare Foundation
🇺🇸
Memphis, Tennessee, United States
Bluesleep clinic
🇺🇸
New York, New York, United States
Alessi Clinic
🇺🇸
Beverly Hills, California, United States
ENT of Georgia
🇺🇸
Atlanta, Georgia, United States
Otolaryngology Colorado
🇺🇸
Greenwood Village, Colorado, United States
Institutional Review Board for Human Research (IRB)
🇺🇸
Charleston, South Carolina, United States