The effect of intranasal steroid budesonide on sleep disturbance and daytime somnolence in patients with perennial allergic rhinitis

Abstract

Rationale The objective of this study was to determine whether intranasal corticosteroid budesonide reduced complaints of nasal congestion, poor sleep, daytime fatigue, and somnolence in patients with perennial allergic rhinitis (PAR). Methods Following IRB approval, twenty-six subjects were enrolled in a double-blind, placebo-controlled, crossover study using Balaam's design. Patients were treated with intranasal steroid spray budesonide or placebo. 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. Results The daily diary data showed significant improvement in nasal congestion (p=0.04) and daytime sleepiness (p=0.01), and marginally significant reduction in daytime fatigue (p=0.08) in the budesonide group compared to the placebo group. The sleep measures demonstrated 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. Conclusions Nasal corticosteroid budesonide is effective in reducing nasal congestion, daytime somnolence, and daytime fatigue, and improving sleep quality and the PAR patients' quality of life.