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Table 5 Subject diary ratings of nasal stuffiness 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
Mean (SD) before strip application 2.00 (0.56) 1.95 (0.39) 1.79 (0.54) 37.74 (17.14) 27.90 (20.46) 35.89 (14.64)
Mean (SD) after strip application 1.80 (0.70) 1.10 (0.79) 1.26 (0.56) 45.84 (23.06) 61.45 (25.85) 57.68 (22.58)
LS mean change after vs before strip application (95% CI); P value − 0.11 (− 0.40 to 0.18); P = 0.4637 − 0.77 (− 1.06 to − 0.47); P < 0.0001 − 0.50 (− 0.81 to − 0.19); P = 0.0019 7.66 (− 2.93 to 18.25); P = 0.1528 29.10 (18.73 to 39.47); P < 0.0001 18.80 (7.86 to 29.74); P = 0.0011
P value for comparison with placebo P = 0.0016c P = 0.0580 P = 0.0040c P = 0.1236
P value for comparison with BRNS P = 0.1986 P = 0.1561
Day 3
Mean (SD) before strip application 1.90 (0.55) 1.90 (0.64) 1.58 (0.69) 38.32 (19.29) 30.05 (20.41) 46.42 (24.13)
Mean (SD) after strip application 1.60 (0.75) 1.16 (0.90) 1.16 (0.69) 49.74 (22.10) 59.25 (27.47) 62.16 (24.85)
LS mean change after vs before strip application (95% CI); P value − 0.20 (− 0.51 to 0.11); P = 0.2047 − 0.66 (− 0.99 to − 0.33); P = 0.0002 − 0.41 (− 0.75 to − 0.07); P = 0.0176 9.40 (− 1.23 to 20.04); P = 0.0819 23.50 (12.86 to 34.13); P < 0.0001 16.75 (5.57 to 27.93); P = 0.0040
P value for comparison with placebo P = 0.0377c P = 0.3447 P = 0.0539 P = 0.3152
P value for comparison with BRNS P = 0.2733 P = 0.3678
Day 7
Mean (SD) before strip application 1.70 (0.73) 1.75 (0.55) 1.63 (0.60) 37.74 (22.42) 30.75 (21.75) 42.05 (21.37)
Mean (SD) after strip application 1.55 (0.89) 1.00 (0.80) 1.16 (0.69) 48.63 (26.87) 60.85 (27.31) 64.95 (21.71)
LS mean change after vs before strip application (95% CI); P value − 0.12 (− 0.38 to 0.14); P = 0.3512 − 0.71 (− 0.97 to − 0.45); P < 0.0001 − 0.44 (− 0.71 to − 0.16); P = 0.0022 8.62 (− 1.40 to 18.64); P = 0.0903 25.43 (15.50 to 35.35); P < 0.0001 21.43 (11.08 to 31.79); P = 0.0001
P value for comparison with placebo P = 0.0015c P = 0.0815 P = 0.0153c P = 0.0635
P value for comparison with BRNS P = 0.1345 P = 0.5600
Day 14
Mean (SD) before strip application 1.58 (0.61) 1.40 (0.60) 1.61 (0.70) 43.84 (22.32) 40.90 (24.73) 45.78 (23.99)
Mean (SD) after strip application 1.35 (0.79) 0.85 (0.88) 1.06 (0.88) 53.21 (25.94) 68 (25.51) 69.56 (24.12)
LS mean change after vs before strip application (95% CI); P value − 0.09 (− 0.45 to 0.27); P = 0.6129 − 0.50 (− 0.83 to − 0.17); P = 0.0036 − 0.45 (− 0.80 to − 0.09); P = 0.0142 5.44 (− 4.86 to 15.74); P = 0.2942 21.47 (11.33 to 31.60); P < 0.0001 20.10 (9.36 to 30.85); P = 0.0004
P value for comparison with placebo P = 0.0786 P = 0.1356 P = 0.0230c P = 0.0417c
P value for comparison with BRNS P = 0.8063 P = 0.8451
  1. BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, SD standard deviation, VAS visual analog scale
  2. a Subjects rated how stuffed their noses felt on a scale of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms
  3. b VAS scale of 0 = nose is extremely blocked to 100 = nose is extremely clear
  4. c Significant difference between treatments