Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial.
Level 2 - randomized trial
Individual randomized, double-blind, placebo-controlled trial
PubMed 30154874 · doi:10.1186/s13223-018-0258-5
What was done
A randomized, double-blind, placebo-controlled exploratory trial evaluated 59 adults with chronic nocturnal nasal congestion and sleep difficulties. Participants were randomized to use one of three interventions nightly for 2 weeks: a standard marketed clear Breathe Right Nasal Strip (BRNS), a prototype asymmetric butterfly-shaped strip, or a springless asymmetric butterfly placebo strip. Outcomes were changes 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).
What was found
At day 7, both the butterfly prototype and BRNS significantly improved PIRS sleep satisfaction versus placebo (least square mean changes: -0.7 and -0.6 vs -0.2, respectively; P < 0.05). At day 14, the butterfly strip maintained significant improvement versus placebo on PIRS satisfaction (-1.0 vs -0.5). On the NRQLQ at day 7, both the butterfly strip and BRNS improved waking symptoms compared to placebo (LS mean changes: -7.9 and -7.2 vs -4.1; P < 0.05), and BRNS significantly improved sleep problems versus placebo (-7.4 vs -4.2). No significant differences between active strips and placebo were detected on the CQ7.
Why it matters
Mechanical external nasal dilator strips offer a modest, non-pharmacologic option to improve subjective sleep satisfaction and morning symptom burden in people with nocturnal nasal congestion.
Limits
The sample size was small (n = 59 across three treatment arms), reducing statistical power. All evaluated outcomes were subjective self-report questionnaires, without objective physiological assessments such as acoustic rhinometry, nasal airflow measurement, or polysomnography. The study duration was limited to 2 weeks, preventing assessment of long-term efficacy or adherence.
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