OBJECTIVES: We sought to determine whether increasing temperature-controlled radiofrequency tissue ablation (TCRFTA) treatments provide incremental improvement in outcomes of obstructive sleep apnea syndrome (OSAS). METHODS: Twenty-six subjects randomized to TCRFTA treatment for mild to moderate OSAS were studied at baseline, 1 month after 3 tongue treatments (interim), and then 2 months after 2 additional tongue and palate treatments (final). Outcomes included OSA-specific quality of life (Functional Outcomes of Sleep Questionnaire [FOSQ] and Symptoms of Nocturnal Obstruction and Related Events [SNORE25]), daytime sleepiness, and reaction times (slowest, median, and fastest). RESULTS: Interim outcomes were significantly better than baseline for FOSQ and SNORE25 (P < 0.05), with a trend toward improvement for sleepiness (P = 0.06). Final outcomes were significantly better than interim outcomes for FOSQ, sleepiness, slowest and medianreaction time (all P < 0.05), and nonsignificantly improved for SNORE25 (P = 0.30) and fastest reaction time (P = 0.18). All final outcomes were improved from baseline (P < 0.05). CONCLUSIONS: Three TCRFTA tongue treatments significantly improved OSA-specific quality of life. An additional 2 TCRFTA tongue and palate treatment sessions further significantly improved quality of life and reaction times.
RCT Entities:
OBJECTIVES: We sought to determine whether increasing temperature-controlled radiofrequency tissue ablation (TCRFTA) treatments provide incremental improvement in outcomes of obstructive sleep apnea syndrome (OSAS). METHODS: Twenty-six subjects randomized to TCRFTA treatment for mild to moderate OSAS were studied at baseline, 1 month after 3 tongue treatments (interim), and then 2 months after 2 additional tongue and palate treatments (final). Outcomes included OSA-specific quality of life (Functional Outcomes of Sleep Questionnaire [FOSQ] and Symptoms of Nocturnal Obstruction and Related Events [SNORE25]), daytime sleepiness, and reaction times (slowest, median, and fastest). RESULTS: Interim outcomes were significantly better than baseline for FOSQ and SNORE25 (P < 0.05), with a trend toward improvement for sleepiness (P = 0.06). Final outcomes were significantly better than interim outcomes for FOSQ, sleepiness, slowest and median reaction time (all P < 0.05), and nonsignificantly improved for SNORE25 (P = 0.30) and fastest reaction time (P = 0.18). All final outcomes were improved from baseline (P < 0.05). CONCLUSIONS: Three TCRFTA tongue treatments significantly improved OSA-specific quality of life. An additional 2 TCRFTA tongue and palate treatment sessions further significantly improved quality of life and reaction times.
Authors: Jonathan R Skirko; Kathryn T James; Louis P Garrison; Edward M Weaver Journal: JAMA Otolaryngol Head Neck Surg Date: 2020-03-01 Impact factor: 6.223