A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome.
OBJECTIVE
The study goal was to determine the effectiveness of (1) multilevel temperature-controlled radiofrequency tissue ablation (TCRFTA) or (2) continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea syndrome (OSAS).


METHODS
We conducted a randomized, placebo-controlled, 2-site trial, comparing TCRFTA (n = 30) and CPAP (n = 30) with sham-placebo (n = 30) using intention-to-treat analysis.


RESULTS
Compared with pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality of life (QOL), and subjective sleepiness (all P < 0.05). Compared with sham-placebo, TCRFTA improved QOL, airway volume, apnea index, and respiratory arousal index (all P < 0.05). TCRFTA side effects and complications were mild, temporary, and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared with sham-placebo (all P < 0.05). Significant differences were not seen between TCRFTA and CPAP outcomes.


CONCLUSIONS
TCRFTA and CPAP each improve QOL for mild-moderate OSAS patients. TCRFTA improvements may result from changes in airway volume, apnea index, and respiratory arousal index.
Woodson
B Tucker
BT
Department of Otoraryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, WI 53226, USA. bwoodson@mcw.edu
Steward
David L
DL
Weaver
Edward M
EM
Javaheri
Shahrokh
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D011175:Positive-Pressure Respiration; D011788:Quality of Life; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D013696:Temperature; D016896:Treatment Outcome