The effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis, sleep, and daytime somnolence in perennial allergic rhinitis.

Recent data suggested that daytime somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime somnolence. Previously, we showed that nasal steroids improved all three symptoms. Presently, we have not performed objective sleep testing to determine if there is a correlation between subjective improvement of congestion, sleep, and daytime somnolence. The objective of this 8-week, double-blind, placebo-controlled study was to determine if topical nasal fluticasone is effective at decreasing subjective congestion and daytime somnolence and improving sleep and if this improvement correlated with a change in overnight sleep testing (polysomnography). We recruited 32 subjects with perennial allergic rhinitis and randomized them in a double-blinded, cross-over fashion, to receive placebo or fluticasone (50 micrograms a spray), 2 sprays each side everyday, using Balaam's design. Questionnaires, quality of life instruments, daily diary, Epworth Sleepiness Scale, and an overnight sleep test with polysomnograms were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Correlations between arousals on sleep tests and subjective tests were performed. Fluticasone improved subjective sleep when compared with placebo (p = 0.04); however, there was no difference in the apnea/hypopnea index in those that were treated. Daytime sleepiness and fatigue were decreased by > 10% in the treated group; however, this was not statistically significant. However, fluticasone used at approved doses improves subjective sleep in patients with perennial allergic rhinitis without a change in the apnea/hypopnea index.

RCT Entities:   Population Interventions Outcomes