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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
RFA treatment using CelonProSleep plus system
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
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Time frame: 6 months following last treatment
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