Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
Primary Purpose
Apnea, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RFA treatment
Sponsored by
About this trial
This is an interventional treatment trial for Apnea, Sleep
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
Sites / Locations
- Alessi Clinic
- Otolaryngology Colorado
- ENT of Georgia
- Bluesleep clinic
- Institutional Review Board for Human Research (IRB)
- Methodist Healthcare Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RFA treatment
Arm Description
RFA treatment performed with CelonProSleep plus device
Outcomes
Primary Outcome Measures
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT02349893
First Posted
January 24, 2015
Last Updated
June 27, 2022
Sponsor
Olympus Surgical Technologies Europe
1. Study Identification
Unique Protocol Identification Number
NCT02349893
Brief Title
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
Official Title
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Surgical Technologies Europe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA treatment
Arm Type
Experimental
Arm Description
RFA treatment performed with CelonProSleep plus device
Intervention Type
Device
Intervention Name(s)
RFA treatment
Intervention Description
RFA treatment using CelonProSleep plus system
Primary Outcome Measure Information:
Title
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
Description
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Time Frame
6 months following last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun Nguyen, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alessi Clinic
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Otolaryngology Colorado
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Bluesleep clinic
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Institutional Review Board for Human Research (IRB)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8570
Country
United States
Facility Name
Methodist Healthcare Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
We'll reach out to this number within 24 hrs