Radiofrequency treatment of turbinate hypertrophy in subjects using continuous positive airway pressure: A randomized, double-blind, placebo-controlled clinical pilot trial

Objectives: To estimate the treatment effect of temperature-controlled radi o-frequency (TCRF) reduction of turbinate hypertrophy in patients with slee p-disordered breathing (SDB) treated with nasal continuous positive airway pressure (CPAP), and to assess the impact of study design on this estimate. Study Design: Prospective, randomized, double-blind, placebo-controlled cl inical pilot trial. Methods. Twenty-two CPAP-treated patients with SDB with turbinate hypertrophy were randomly assigned to either TCRF turbinate trea tment (mean energy 415 +/- 37 J/turbinate; n = 17) or placebo control (n = 5). Changes in nasal obstruction were evaluated between pretreatment and 4 weeks post-treatment. The primary outcome assessed changes in the blinded e xaminers' findings of nasal obstruction on a visual analogue scale (VAS). S econdary outcomes included blinded patients' and unblinded examiner assessm ents of nasal obstruction (VAS), nightly CPAP use, adherence, and tolerance , along with sleepiness and general health status scales. The treatment gro up findings were subtracted from the changes in the placebo group to yield treatment effect. Results: The primary outcome treatment effect by VAS was -0.9 cm. (95% confidence interval [CI], -2.4, 0.7), and beyond the placebo effect of -1.5 cm. (95% CI: -3.4, 0.3). The secondary treatment effect of t he unblinded examiner was -3.0 cm (95% CI, -4.9, -1.1). A beneficial treatm ent effect was also seen on every secondary outcome except general health s tatus, but only self-reported CPAP adherence (P = .03) was statistically si gnificant. Conclusions: TCRF turbinate treatment appears to benefit nasal o bstruction and CPAP treatment for SDB. Placebo control and double blinding are critical for establishing the true treatment effect. A future definitiv e trial is feasible to establish statistical significance of these findings . Key Words. Temperature-controlled radiofrequency, turbinate hypertrophy, sleep-disordered breathing, CPAP, placebo-controlled, randomized trial, dou ble-blind.