Objectives: To estimate the treatment effect of temperature-controlled radiofrequency (TCRF) reduction of turbinate hypertrophy in patients with sleep-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 clinical pilot trial.
Methods: Twenty-two CPAP-treated patients with SDB with turbinate hypertrophy were randomly assigned to either TCRF turbinate treatment (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 examiners' findings of nasal obstruction on a visual analogue scale (VAS). Secondary outcomes included blinded patients' and unblinded examiner assessments of nasal obstruction (VAS), nightly CPAP use, adherence, and tolerance, along with sleepiness and general health status scales. The treatment group 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 the unblinded examiner was -3.0 cm (95% CI, -4.9, -1.1). A beneficial treatment effect was also seen on every secondary outcome except general health status, but only self-reported CPAP adherence (P = .03) was statistically significant.
Conclusions: TCRF turbinate treatment appears to benefit nasal obstruction and CPAP treatment for SDB. Placebo control and double blinding are critical for establishing the true treatment effect. A future definitive trial is feasible to establish statistical significance of these findings.