Table 5.
MOS sleep sub-scores for active treatment group and placebo group at baseline, 4 weeks and 8 weeks
| MOS sub-scale |
Group | Baseline Mean ± SD (range) |
P value | 4 Weeks Mean ± SD (range) |
P value | Change at 4 weeks | Effect size [95% CI] |
8 Weeks Mean ± SD (range) |
P value | Change at 8 weeks | Effect size [95% CI] |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sleep disturbance* | Active |
3.54 ± 0.79 (1.75–4.75) |
0.64 |
3.92 ± 0.75 (2.00–5.00) |
0.071 | 0.37 |
0.458 [−0.033 to 0.945] |
4.20 ± 0.56 (2.25–5.00) |
0.0011 | 0.65 |
0.843 [0.336 to 1.344] |
| Placebo |
3.64 ± 0.91 (1.75–5.00) |
3.55 ± 0.84 (2.00–5.00) |
−0.09 |
3.62 ± 0.79 (2.00–4.75) |
−0.02 | ||||||
| Sleep adequacy* | Active |
3.50 ± 1.47 (1.50–6.00) |
0.391 |
2.59 ± 1.27 (1.00–5.50) |
0.04 | −0.91 |
−0.507 [−0.995 to −0.014] |
2.12 ± 0.91 (1.00–4.00) |
0.0011 | −1.38 |
−0.831 [−1.331 to 0.324] |
| Placebo |
3.15 ± 1.29 (1.00–6.00) |
3.24 ± 1.31 (1.00–5.50) |
0.09 |
3.05 ± 1.28 (1.50–6.00) |
−0.11 | ||||||
| Sleep quantity* | Active |
6.02 ± 1.58 (2.00–1.00) |
0.09 |
6.74 ± 1.43 (3.00–1.00) |
0.69 | 0.72 |
6.83 ± 1.28 (4.00–9.00) |
0.52 | 0.82 | ||
| Placebo |
6.67 ± 1.53 (4.00–1.00) |
6.88 ± 1.38 (4.00–1.00) |
0.21 |
7.04 ± 1.39 (4.00–1.00) |
0.38 | ||||||
| Daytime somnolence* | Active |
4.44 ± 1.14 (2.33–6.00) |
0.111 |
5.05 ± 0.89 (3.00–6.00) |
0.001 | 0.61 |
0.923 [0.411 to 1.428] |
5.30 ± 0.81 (3.33–6.00) |
<0.0011 | 0.86 |
1.178 [0.651 to 1.698] |
| Placebo |
3.90 ± 1.34 (1.00–6.00) |
3.99 ± 1.36 (1.00–6.00) |
0.09 |
4.08 ± 1.23 (1.00–6.00) |
0.18 | ||||||
| Snoring** | Active |
3.67 ± 1.90 (1.00–6.00) |
0.071 |
3.94 ± 1.85 (1.00–6.00) |
0.43 | 0.27 |
3.91 ± 1.76 (1.00–6.00) |
0.221 | 0.24 | ||
| Placebo |
4.48 ± 1.66 (1.00–6.00) |
4.39 ± 1.48 (1.00–6.00) |
−0.09 |
4.45 ± 1.42 (2.00–6.00) |
−0.03 | ||||||
| Shortness of breath or headache** | Active |
5.76 ± 0.50 (4.00–6.00) |
0.421 |
5.82 ± 0.46 (4.00–6.00) |
0.11 | 0.06 |
5.93 ± 0.24 (5.00–6.00) |
0.041 | 0.18 |
0.540 [0.047 to 1.029 |
|
| Placebo |
5.36 ± 1.32 (1.00–6.00) |
5.36 ± 1.17 (2.00–6.00) |
0.00 |
5.54 ± 1.00) (2.00–6.00) |
0.18 | ||||||
| Sleep Problem Index** | Active |
4.01 ± 0.35 (3.22–4.78) |
0.25 |
4.12 ± 0.37 (3.11–5.00) |
0.01 | 0.11 |
4.20 ± 0.29 (3.11–4.78) |
<0.001 | 0.18 |
0.859 [0.351 to 1.361] |
|
| Placebo |
3.82 ± 0.58 (2.11–4.67) |
3.82 ± 0.53 (2.56–4.56) |
0.0003 |
3.86 ± 0.46 (2.78–4.44) |
0.04 |
MOS score ratings depict the level of impact of each subcategory. Questions are a mix of positively (*) and negatively phrased (**) questions
1Shapiro–Wilk distribution test found these data (in one or both arms) to be not normally distributed; tests of significance are performed nonparametrically with Mann–Whitney U. Active treatment group n = 33, Placebo group n = 33. Statistical significance set at P ≤ 0.05