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

NCT ID: NCT02349893

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2021-06-30

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).

Conditions

Apnea, Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA treatment

RFA treatment performed with CelonProSleep plus device

Group Type: EXPERIMENTAL

RFA treatment

Intervention Type: DEVICE

RFA treatment using CelonProSleep plus system

Interventions

RFA treatment

RFA treatment using CelonProSleep plus system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus Surgical Technologies Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaun Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Alessi Clinic

Beverly Hills, California, United States

Otolaryngology Colorado

Greenwood Village, Colorado, United States

ENT of Georgia

Atlanta, Georgia, United States

Bluesleep clinic

New York, New York, United States

Institutional Review Board for Human Research (IRB)

Charleston, South Carolina, United States

Methodist Healthcare Foundation

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id