Table 2.
Device usage analysis at 6 months
| Visit 3 (6 months) | Home therapy group | Control group | Between-group difference (h/day) | p value |
|---|---|---|---|---|
| Usage (h/day) | Usage (h/day) | |||
| PP population | (n = 89) | (n = 93) | ||
|
Mean ± SD (95% CI) |
4.38 ± 2.04 (3.95, 4.81) |
4.32 ± 2.28 (3.85, 4.79) |
0.06 ± 2.17 (−0.57, 0.70) |
|
| Median (range) | 4.40 (0.10–9.58) | 4.58 (0.00–8.07) | ||
| NIM −0.3 h/day | 0.130 | |||
| NIM −0.5 h/day | 0.041 | |||
|
Sensitivity analysis* ITT population |
(n = 110) | (n = 114) | ||
|
Mean ± SD (95% CI) |
3.54 ± 2.52 (3.07, 4.02) |
3.52 ± 2.66 (3.03, 4.02) |
0.02 ± 2.59 (−0.66, 0.70) |
|
| Median (range) | 3.76 (0.0–9.6) | 3.85 (0.0–8.1) | ||
| NIM −0.5 h/day | 0.067 |
*Missing mean usage imputed as zero
CI confidence interval, h hours, ITT intention-to-treat, NIM non-inferiority margin, PP per-protocol, SD standard deviation