Table 2.
Impact of cannabinoid treatment on sleep. Comparison of treatment effects in the 1st 12-week period.
| Placebo n = 45 [Change in Points] |
Pure Cannabinoids n = 42 [Change in Points] |
Whole Plant n = 44 [Change in Points] |
Total n = 131 [Change in Points] |
Sig ^ | |
|---|---|---|---|---|---|
| Total CSHQ score | |||||
|
Mean ± SD [median, range] |
−1.4 ± 6.6 [−1.9, −20.3–13.0] |
−2.9 ± 9.2 [−1.5, −27.9–18.0] |
−2.3 ± 5.6 [−1.5, −18.0–7.3] |
−2.2 ± 7.2 [−1.9, −27.9–18.0] |
0.63 |
| Bedtime Resistance | |||||
|
Mean ± SD [median, range] |
−0.6 ± 1.6 [0.0, −4.0–3.0] |
−0.5 ± 2.7 [0.0, −9.0–5.7] |
−0.3 ± 1.6 [0.0, −6.0–3.0] |
−0.4 ± 2.0 [0.0, −9.0–5.7] |
0.79 |
| Sleep Onset Delay | |||||
|
Mean ± SD [median, range] |
−0.1 ± 0.6 [0.0, −1.0–2.0] |
−0.1 ± 0.8 [0.0, −2.0–2.0] |
−0.2 ± 0.8 [0.0, −2.0–1.0] |
−0.2 ± 0.7 [0.0, −2.0–2.0] |
0.98 |
| Sleep Duration | |||||
|
Mean ± SD [median, range] |
−0.1 ± 1.6 [0.0, −4.0–4.0] |
0.0 ± 2.0 [0.0, −5.0–4.0] |
−0.5 ± 1.9 [0.0, −5.0–4.0] |
−0.2 ± 1.8 [0.0, −5.0–4.0] |
0.38 |
| Sleep Anxiety | |||||
|
Mean ± SD [median, range] |
−0.4 ± 1.2 [0.0, −4.0–2.0] |
−0.6 ± 1.3 [0.0, −4.0–1.7] |
−0.2 ± 1.5 [0.0, −4.0–2.0] |
−0.4 ± 1.3 [0.0, −4.0–2.0] |
0.59 |
| Night Wakings | |||||
|
Mean ± SD [median, range] |
−0.2 ± 1.3 [0.0, −3.0–3.0] |
−0.8 ± 1.5 [−0.5, −4.0–1.0] |
−0.6 ± 1.2 [0.0, −4.0–1.0] |
−0.5 ± 1.4 [0.0, −4.0–3.0] |
0.11 |
| Parasomnias | |||||
|
Mean ± SD [median, range] |
−0.2 ± 1.6 [0.0, −4.0–4.0] |
−0.6 ± 1.9 [−0.9, −7.0–4.0] |
−0.5 ± 1.4 [0.0, −4.5–2.3] |
−0.5 ± 1.6 [0.0, −7.0–4.0] |
0.53 |
| Sleep Disordered Breathing | |||||
|
Mean ± SD [median, range] |
−0.0 ± 0.9 [0.0, −2.0–3.0] |
−0.3 ± 1.0 [−0.0, −4.0–1.0] |
−0.1 ± 0.8 [0.0, −2.0–1.0] |
−0.2 ± 0.9 [0.0, −4.0–3.0] |
0.36 |
| Daytime Sleepiness | |||||
|
Mean ± SD [median, range] |
0.1 ± 3.0 [0.0, −9.0–7.8] |
0.2 ± 3.5 [0.0, −7.0–7.0] |
0.0 ± 2.7 [0.0, −5.0–5.0] |
0.1 ± 3.1 [0.0, −9.0–7.8] |
0.96 |
Between-subject analyses of the change in the CSHQ scores following treatment in the first treatment period. CSHQ—Children’s Sleep Habits Questionnaire. Positive change (increment of CSHQ scores) indicates worsening of the sleep disorder. Change in the CSHQ scores from baseline following treatment is compared between the 3 treatment arms. ^ One-way ANOVA for influence of treatments between study groups. Notably, the difference between cannabinoid treatment and placebo was not statistically significant, even when combining the two cannabinoid treatments into one group, compared to placebo (data not shown).