The effect of intranasal steroid budesonide on the congestion-related sleep disturbance and daytime somnolence in patients with perennial allergic rhinitis.

Patients with perennial allergic rhinitis (PAR) often present with nasal congestion, poor sleep, daytime fatigue, and daytime somnolence. Pharmacologic therapy that reduces nasal congestion should improve the PAR patients' sleep quality and reduce daytime somnolence and fatigue. Our hypothesis is that intranasal steroid budesonide (BUD), an effective topical anti-inflammatory agent, will reduce nasal congestion and improve the patients' quality of life. The objective of this study was to determine whether topical steroid BUD improves sleep, daytime somnolence, and fatigue in patients with PAR. Twenty-six subjects were enrolled in a double-blind, placebo-controlled, crossover study using Balaam's design. Patients were treated with intranasal steroid spray BUD or placebo. The Epworth Sleepiness Scale, daily diary, and questionnaires were used as tools for subjective data analysis, which focused on nasal symptoms, sleep quality, daytime somnolence, and fatigue. The results were summarized and compared by PROC MIXED in SAS. The daily diary data showed significant improvement in self-reported nasal congestion (p = 0.04) and daytime sleepiness (p = 0.01) and a trend in reduction of daytime fatigue (p = 0.08) in the BUD group compared with the placebo group. The sleep measures showed statistically significant improvement in total sleep measures score (p = 0.04), "sleep compared with absolute" (p = 0.01), and "refreshing and restorative" sleep (p = 0.04) in the active group. Nasal corticosteroid BUD is effective in reducing nasal congestion, daytime somnolence, and daytime fatigue, and improving sleep quality in PAR.

RCT Entities:   Population Interventions Outcomes