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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