Craig · Allergy and asthma proceedings 2003 · randomized double-blind placebo-controlled crossover trial · n=32

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

Cited 82 times in the scientific literature.

Level 2 - randomized trial

Individual randomized, double-blind, placebo-controlled crossover trial

PubMed 12635578 · record verified 2026-08-29

What was done

In an 8-week, double-blind, placebo-controlled crossover study using Balaam's design, 32 subjects with perennial allergic rhinitis were randomized to receive topical nasal fluticasone (50 micrograms/spray, 2 sprays per side daily) or placebo. Each treatment period lasted 4 weeks. Symptoms of congestion, sleep, daytime somnolence, and fatigue were assessed using questionnaires, quality of life instruments, daily diaries, and the Epworth Sleepiness Scale. Objective sleep parameters, including the apnea/hypopnea index and sleep arousals, were measured using overnight polysomnography during the last 2 weeks of each treatment period.

What was found

Fluticasone significantly improved subjective sleep compared with placebo (p = 0.04). There was no significant difference between treatments in the apnea/hypopnea index. Daytime sleepiness and fatigue decreased by > 10% in the fluticasone group, but this difference was not statistically significant. Exact baseline and post-treatment numeric values for the sleep scores and polysomnography indices were not reported in the abstract.

Why it matters

This trial demonstrates that intranasal corticosteroids can alleviate perceived sleep impairment in perennial allergic rhinitis, though this subjective improvement occurs without measurable changes in objective sleep-disordered breathing metrics such as the apnea/hypopnea index.

Limits

The study had a small sample size (n = 32), which may have limited power to detect differences in daytime sleepiness or polysomnographic measures. The abstract omits exact point estimates, confidence intervals, and detailed numerical results for the correlation analyses between objective arousals and subjective metrics.

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