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Table 6 Subject diary ratings of breathing before and after strip application at bedtime (ITT population)

From: Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

  Categorical ratingsa   VAS ratingsb
Asymmetric placebo (n = 20) BRNS clear (n = 20) Asymmetric butterfly (n = 19) Asymmetric placebo (n = 20) BRNS clear (n = 20) Asymmetric butterfly (n = 19)
Day 1 Day 1
Mean (SD) before strip application NA NA NA Mean (SD) before strip application 34.58 (15.80) 27.85 (20.58) 34.00 (14.82)
Mean (SD) after strip application 1.20 (1.47) 2.45 (1.40) 1.42 (2.12) Mean (SD) after strip application 43.11 (24.07) 61.55 (26.72) 55.00 (24.87)
LS mean after strip application 1.07 2.29 1.24 LS mean change after vs before strip application (95% CI); P value 7.37 (− 3.73 to 18.46); P = 0.1886 30.24 (19.38 to 41.10); P < 0.0001 19.21 (7.89 to 30.54); P = 0.0013
P value for comparison with placebo – P = 0.0254c P = 0.7624 P value for comparison with placebo – P = 0.0032c P = 0.1157
P value for comparison with BRNS – – P = 0.0546 P value for comparison with BRNS – – P = 0.1420
Day 3 Day 3
Mean (SD) before strip application NA NA NA Mean (SD) before strip application 37.95 (19.84) 29.35 (20.30) 45.11 (23.87)
Mean (SD) after strip application 1.20 (1.36) 2.40 (1.67) 1.74 (1.73) Mean (SD) after strip application 48.53 (20.67) 58.90 (26.64) 61.42 (24.74)
LS mean after strip application 0.96 2.10 1.39 LS mean change after vs before strip application (95% CI); P value 8.67 (− 1.65 to 18.99); P = 0.0978 23.70 (13.42 to 33.97); P < 0.0001 17.10 (6.26 to 27.95); P = 0.0026
P value for comparison with placebo – P = 0.0208c P = 0.3799 P value for comparison with placebo – P = 0.0348c P = 0.2341
P value for comparison with BRNS – – P = 0.1494 P value for comparison with BRNS – – P = 0.3625
Day 7 Day 7
Mean (SD) before strip application NA NA NA Mean (SD) before strip application 36.37 (21.95) 32.10 (22.39) 40.53 (18.23)
Mean (SD) after strip application 1.20 (1.47) 2.80 (1.40) 1.79 (1.48) Mean (SD) after strip application 47.42 (26.74) 58.95 (28.54) 61.11 (21.79)
LS mean after strip application 1.09 2.66 1.62 LS mean change after vs before strip application (95% CI); P value 8.75 (− 1.43 to 18.92); P = 0.0905 23.25 (13.21 to 33.29); P < 0.0001 18.89 (8.40 to 29.38); P = 0.0007
P value for comparison with placebo – P = 0.0011c P = 0.2497 P value for comparison with placebo – P = 0.0370c P = 0.1458
P value for comparison with BRNS – – P = 0.0292c P value for comparison with BRNS – – P = 0.5278
Day 14 Day 14
Mean (SD) before strip application NA NA NA Mean (SD) before strip application 43.21 (24.00) 39.90 (24.07) 45.89 (22.29)
Mean (SD) after strip application 0.89 (1.41) 2.70 (1.66) 2.00 (1.72) Mean (SD) after strip application 51.05 (25.39) 68.70 (26.64) 67.56 (23.61)
LS mean after strip application 0.74 2.54 1.82 LS mean change after vs before strip application (95% CI); P value 4.15 (− 5.70 to 14.01); P = 0.4017 23.52 (13.82 to 33.23); P < 0.0001 18.43 (8.14 to 28.72); P = 0.0007
P value for comparison with placebo – P = 0.0009c P = 0.0438c P value for comparison with placebo – P = 0.0046c P = 0.0385c
P value for comparison with BRNS – – P = 0.1693 P value for comparison with BRNS – – P = 0.4483
  1. BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, NA not applicable; SD standard deviation, VAS visual analog scale
  2. a Subjects rated how breathing felt after they applied the strip using a scale of − 5 = much worse, 0 = same, and 5 = much better
  3. b VAS scale of 0 = extremely difficult to breathe to 100 = extremely easy to breathe
  4. c Significant difference between treatments
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Allergy, Asthma & Clinical Immunology

ISSN: 1710-1492

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