Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial.

Background: This exploratory study investigated effects of a new asymmetric butterfly-shaped prototype nasal dilator strip and the currently marketed clear Breathe Right Nasal Strip (BRNS) on subjective measures of nasal congestion and sleep quality.

Methods: In this randomized, double-blind study, subjects with chronic nasal congestion and sleep difficulties were assigned a BRNS clear strip, an asymmetric butterfly prototype, or an asymmetric butterfly placebo strip without springs, to use nightly for 2 weeks. The main outcomes included change from baseline to days 7 and 14 on the Pittsburgh Insomnia Rating Scale (PIRS), Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), and Congestion Quantifier Seven-Item Test (CQ7).

Results: The intent-to-treat population included 59 subjects. The butterfly and BRNS strips showed significant ( P  < 0.05) improvement versus placebo on PIRS satisfaction with sleep at day 7 [least square (LS) mean changes: - 0.7, - 0.6, and - 0.2, respectively], and the butterfly strip also showed significant improvement from baseline on this outcome versus placebo at day 14 (- 1.0 vs - 0.5). On the NRQLQ, both the butterfly prototype and BRNS clear were more effective than placebo in improving symptoms on waking at day 7 (LS mean changes: - 7.9, - 7.2, and - 4.1, respectively); the BRNS clear was significantly more effective than placebo in improving sleep problems at day 7 (- 7.4 vs - 4.2). There were no between-treatment differences on the CQ7. All strips were well tolerated.

Conclusions: The asymmetric butterfly prototype and BRNS clear strip significantly improved some subjective measures of nasal congestion and sleep compared with placebo in subjects with nasal congestion and sleep difficulties. Trial registration This study is registered at ClinicalTrials.gov (identifier: NCT01122849).