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 |