Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion.
Level 2 - randomized trial
Randomized crossover trial evaluating objective nasal resistance and active intervention phase
PubMed 31119695 · doi:10.1007/s12325-019-00980-z
What was done
This exploratory study evaluated a prototype nasal dilator strip designed with improved spring force in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. In a 28-day active phase (n = 70), participants applied the strip at bedtime; objective polysomnography (PSG), snoring variables, and breathing route were measured relative to baseline, alongside subjective questionnaires for breathing and sleep. In a separate crossover nasal resistance phase (n = 55), posterior rhinomanometry was used to measure nasal resistance during sleep over two nights (one with strip, one without).
What was found
In the 28-day active phase, participants reported significantly less daytime sleepiness (P < 0.04) and improved ease of breathing, sleep quality, ability to stay asleep, and feeling refreshed in the morning (all P < 0.0001). Standard objective PSG metrics were generally similar with and without the strip, though median wake after sleep onset was numerically lower by ~11 min and spontaneous arousal rates fell by ~37%. In the crossover phase, median sleeping nasal resistance (at 0.2–0.25 l/s) was 39.1% lower with the strip (n = 37) compared to without (n = 36) (1.34 vs. 2.20 cmH2O/l/s; P = 0.048).
Why it matters
The study demonstrates that increasing nasal dilator spring force can significantly reduce sleeping airway resistance and subjective congestion symptoms, although the translation to standard objective polysomnographic endpoints is limited.
Limits
The active 28-day phase was compared only to baseline rather than a sham control, making subjective outcomes vulnerable to placebo effects. Sample sizes were modest, particularly for evaluable nasal resistance measurements (n = 36–37). Primary objective polysomnography parameters showed no statistically significant change.
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