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

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).

Study Overview

• Status: Completed
• Conditions: Apnea, Sleep
• Intervention / Treatment: Device: RFA treatment

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Alessi Clinic
  • Colorado
    • Greenwood Village, Colorado, United States, 80909
      • Otolaryngology Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • ENT of Georgia
  • New York
    • New York, New York, United States, 10003
      • Bluesleep clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8570
      • Institutional Review Board for Human Research (IRB)
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist Healthcare Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFA treatment; RFA treatment performed with CelonProSleep plus device	Device: RFA treatment; RFA treatment using CelonProSleep plus system

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Olympus Surgical Technologies Europe
• Investigators: Principal Investigator: Shaun Nguyen, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 24, 2015
• First Submitted That Met QC Criteria: January 24, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)