Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

INTRODUCTION: This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. METHODS: Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline. Nasal breathing, congestion, and sleep were measured subjectively using rating scales and questionnaires. During a crossover nasal resistance phase (n = 55), nasal resistance was measured using posterior rhinomanometry with the strip applied on one of two nights. RESULTS: In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P < 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P < 0.0001). However, while objective polysomnography metrics were generally similar with and without the strip, median wake after sleep onset time was numerically reduced by ~ 11 min, and the spontaneous arousal rate fell by ~ 37%. In the nasal resistance phase (n = 55), median resistance (at 0.2–0.25 l/s) while asleep was 39.1% lower with (n = 37) versus without (n = 36) the strip (1.34 vs. 2.20 cmH(2)O/l/s; P = 0.048). CONCLUSIONS: This exploratory study supports a role for the improved spring force nasal dilator strip in alleviating sleep-related symptoms in subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings. A larger study is indicated to confirm these preliminary data. CLINICALTRIALS.GOV IDENTIFIER: NCT03105297. FUNDING: GlaxoSmithKline Consumer Healthcare. PLAIN LANGUAGE SUMMARY: Plain language summary available for this article. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-019-00980-z) contains supplementary material, which is available to authorized users.