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

Apnea, Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349893
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Olympus Surgical Technologies Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

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

Related Conditions & MeSH terms

• Apnea
• Apnea, Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• RFA treatment
RFA treatment using CelonProSleep plus system

Locations

Country	Name	City	State
United States	ENT of Georgia	Atlanta	Georgia
United States	Alessi Clinic	Beverly Hills	California
United States	Institutional Review Board for Human Research (IRB)	Charleston	South Carolina
United States	Otolaryngology Colorado	Greenwood Village	Colorado
United States	Methodist Healthcare Foundation	Memphis	Tennessee
United States	Bluesleep clinic	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Surgical Technologies Europe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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