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Table 2 Pittsburgh Insomnia Rating Scale results (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

PIRS item Asymmetric placebo (n = 20) BRNS clear (n = 20) Asymmetric butterfly (n = 19)
≥ 1 Awakenings after getting to sleep a
Mean (SD) at baseline 2.45 (0.61) 2.10 (0.72) 2.16 (0.83)
Day 7
LS mean change from baseline (95% CI) − 0.69 (− 0.99 to − 0.40) − 0.91 (− 1.21 to − 0.61) − 1.03 (− 1.34 to − 0.72)
P value for comparison with placebo P = 0.2879 P = 0.1029
P value for comparison with BRNS P = 0.5456
Day 14
LS mean change from baseline (95% CI) − 0.84 (− 1.14 to − 0.54) − 1.05 (− 1.36 to − 0.74) − 1.16 (− 1.48 to − 0.84)
P value for comparison with placebo P = 0.3348 P = 0.1429
P value for comparison with BRNS P = 0.5958
Sleep that is not fully refreshing a
Mean (SD) at baseline 2.25 (0.91) 2.30 (0.80) 2.37 (0.60)
Day 7
LS mean change from baseline (95% CI) − 0.71 (− 1.07 to − 0.34) − 1.00 (− 1.37 to − 0.63) − 0.95 (− 1.33 to − 0.56)
P value for comparison with placebo P = 0.2364 P = 0.3457
P value for comparison with BRNS P = 0.8213
Day 14
LS mean change from baseline (95% CI) − 0.92 (− 1.30 to − 0.54) − 1.31 (− 1.69 to − 0.92) − 1.10 (− 1.50 to − 0.70)
P value for comparison with placebo P = 0.1375 P = 0.4795
P value for comparison with BRNS P = 0.4425
Sleep quality compared to most people b
Mean (SD) at baseline  2.25 (0.72) 2.30 (0.66) 2.32 (0.48)
Day 7
LS mean change from baseline (95% CI) − 0.35 (− 0.63 to − 0.07) − 0.72 (− 1.01 to − 0.43) − 0.54 (− 0.84 to − 0.24)
P value for comparison with placebo P = 0.0591 P = 0.3369
P value for comparison with BRNS P = 0.3553
Day 14
LS mean change from baseline (95% CI) − 0.36 (− 0.68 to − 0.04) − 0.71 (− 1.04 to − 0.39) − 0.84 (− 1.17 to − 0.50)
P value for comparison with placebo P = 0.1061 P = 0.0337c
P value for comparison with BRNS P = 0.5750
Satisfaction with sleep b
Mean (SD) at baseline 2.30 (0.80) 2.35 (0.67) 2.63 (0.60)
Day 7
LS mean change from baseline (95% CI) − 0.23 (− 0.50 to 0.03) − 0.64 (− 0.91 to − 0.38) − 0.70 (− 0.98 to − 0.42)
P value for comparison with placebo P = 0.0256c P = 0.0151c
P value for comparison with BRNS P = 0.7686
Day 14
LS mean change from baseline (95% CI) − 0.46 (− 0.76 to − 0.16) − 0.87 (− 1.18 to − 0.57) − 0.95 (− 1.27 to − 0.63)
P value for comparison with placebo P = 0.0503 P = 0.0250c
P value for comparison with BRNS P = 0.7092
  1. BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, PIRS Pittsburgh Insomnia Rating Scale, SD standard deviation
  2. a Scored on a 4-point scale where 0 = not at all bothered, 1 = slightly bothered, 2 = moderately bothered, and 3 = severely bothered
  3. b Scored on a 4-point scale where 0 = excellent, 1 = good, 2 = fair, and 3 = poor
  4. c Significant difference between treatments