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Erschienen in:
Open Access 22.05.2019 | Original Research
Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion
Erschienen in: Advances in Therapy | Ausgabe 7/2019
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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 cmH2O/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.
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