Table 3.
Summary of Post Sleep Questionnaire and Children's Sleep Habits Questionnaire Scores at Baseline and Week 4, Safety Set
| Placebo |
SHP465 MAS |
|||
|---|---|---|---|---|
| Baseline | Week 4 | Baseline | Week 4 | |
| PSQa | ||||
| Mean ± SD minutes to fall asleep per night | 27.0 ± 20.25 | 19.3 ± 16.13 | 27.2 ± 21.51 | 21.0 ± 14.35 |
| Woke up during the night | ||||
| n (%) | 20 (46.5) | 13 (30.2) | 14 (31.1) | 11 (24.4) |
| Mean ± SD number of timesb | 1.4 ± 0.50 | 1.4 ± 0.51 | 1.5 ± 0.76 | 1.3 ± 1.01 |
| Distribution of number of times, n (%) | ||||
| 0 | 0 | 0 | 1 (2.2) | 1 (2.2) |
| 1 | 12 (27.9) | 8 (18.6) | 6 (13.3) | 8 (17.8) |
| 2 | 8 (18.6) | 5 (11.6) | 6 (13.3) | 1 (2.2) |
| 3 | 0 | 0 | 1 (2.2) | 0 |
| 4 | 0 | 0 | 0 | 1 (2.2) |
| Mean ± SD minutes awake per nightb,c | 12.4 ± 8.41 | 8.9 ± 5.18 | 8.0 ± 7.63 | 15.1 ± 17.01 |
| Overall sleep quality during the past week, n (%) | ||||
| Very poor | 1 (2.3) | 0 | 0 | 0 |
| Poor | 4 (9.3) | 3 (7.0) | 6 (13.3) | 6 (13.3) |
| Average | 15 (34.9) | 12 (27.9) | 16 (35.6) | 12 (26.7) |
| Good | 15 (34.9) | 14 (32.6) | 16 (35.6) | 17 (37.8) |
| Very good | 8 (18.6) | 11 (25.6) | 4 (8.9) | 7 (15.6) |
| Past week was a typical week | ||||
| No, n (%) | 4 (9.3) | 4 (9.3) | 6 (13.3) | 6 (13.3) |
| Reason the past week was not typical, n (%) | ||||
| Vacation | 2 (4.7) | 0 | 2 (4.4) | 0 |
| School break | 1 (2.3) | 3 (7.0) | 2 (4.4) | 3 (6.7) |
| Was ill | 0 | 0 | 0 | 1 (2.2) |
| Other | 1 (2.3) | 1 (2.3) | 2 (4.4) | 2 (4.4) |
| Mean ± SD hours sleeping per night | 8.9 ± 1.20 | 9.1 ± 1.34 | 8.8 ± 1.22 | 8.9 ± 1.16 |
| Overall sleep quality,dn (%) | ||||
| Better than usual | 0 | 1 (2.3) | 1 (2.2) | 2 (4.4) |
| Same as usual | 6 (14.0) | 4 (9.3) | 7 (15.6) | 7 (15.6) |
| Worse than usual | 2 (4.7) | 0 | 1 (2.2) | 2 (4.4) |
| CSHQ,e mean ± SD | ||||
| Total sleep disturbance score | 45.3 ± 10.08 | 42.7 ± 9.36 | 45.4 ± 8.65 | 42.8 ± 9.17 |
| Bedtime resistance | 8.3 ± 2.76 | 7.3 ± 1.84 | 8.8 ± 2.94 | 8.3 ± 2.49 |
| Sleep onset delay | 1.8 ± 0.79 | 1.5 ± 0.75 | 1.8 ± 0.83 | 1.5 ± 0.78 |
| Sleep duration | 4.5 ± 1.67 | 4.2 ± 1.51 | 4.4 ± 1.95 | 4.0 ± 1.72 |
| Sleep anxiety | 5.3 ± 1.58 | 5.0 ± 1.65 | 5.5 ± 1.79 | 5.2 ± 1.70 |
| Night waking | 4.2 ± 1.47 | 4.1 ± 1.49 | 3.7 ± 1.14 | 3.7 ± 1.25 |
| Parasomnias | 9.0 ± 2.35 | 8.7 ± 2.73 | 8.6 ± 1.77 | 8.2 ± 1.88 |
| Disordered breathing | 3.5 ± 0.86 | 3.5 ± 1.07 | 3.4 ± 0.71 | 3.3 ± 0.85 |
| Sleepiness | 11.5 ± 3.19 | 10.9 ± 3.09 | 12.0 ± 3.39 | 11.2 ± 3.02 |
a
n = 43 for placebo and n = 42 for SHP465 MAS at baseline; n = 40 for placebo and n = 42 for SHP465 MAS at week 4 (based on average school/week nights).
b
Based on the total number of participants who woke during the night.
c
n = 12 for placebo at week 4.
d
Based on past week.
e
n = 42 for placebo and n = 45 for SHP465 MAS at baseline; n = 41 for placebo and n = 41 for SHP465 MAS at week 4.
CSHQ, Children's Sleep Habits Questionnaire; MAS, mixed amphetamine salts; PSQ, Post Sleep Questionnaire; SD, standard deviation.