Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial
Bibliographic record
Abstract
Abstract 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)
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".