Table 3.
Treatment related difference of absence vs. presence evaluation of individual complaints.
| Individual complaints | Visit | Absence of complaints | χ 2-test | Estimated difference in proportion of absence (ΔZinCyp3-02−control) |
|||||
|---|---|---|---|---|---|---|---|---|---|
| ZinCyp-3-02 N = 89A |
Control N = 90B |
Estimate (%) | Lower CL | Upper CL | |||||
| N | % | N | % | ||||||
| Time to sleep onset | V1 (day 0) | 13 | 14.6 | 16 | 17.8 | — | — | — | — |
| V2 (days 3–5) | 19 | 21.4 | 25 | 27.8 | p = 0.3178 | −6.43 | −19.00 | 6.14 | |
| V3 (day 14) | 58 | 65.2 | 36 | 40.0 | p = 0.0007 | 25.17 | 11.01 | 39.33 | |
| V4 (day 28) | 74 | 84.1 | 46 | 52.3 | p < 0.0001 | 31.82 | 18.88 | 44.75 | |
|
| |||||||||
| Difficulties maintaining sleep | V1 (day 0) | 11 | 12.4 | 8 | 8.9 | — | — | — | — |
| V2 (days 3–5) | 19 | 21.4 | 11 | 12.2 | p = 0.1022 | 9.13 | −1.75 | 20.00 | |
| V3 (day 14) | 36 | 40.5 | 24 | 26.7 | p = 0.0508 | 13.78 | 0.09 | 27.47 | |
| V4 (day 28) | 58 | 65.9 | 37 | 42.1 | p = 0.0015 | 23.86 | 9.56 | 38.16 | |
|
| |||||||||
| Sleep duration (per day) | V1 (day 0) | 34 | 38.2 | 43 | 47.8 | — | — | — | — |
| V2 (days 3–5) | 46 | 51.7 | 50 | 55.6 | p = 0.6037 | −3.87 | −18.47 | 10.73 | |
| V3 (day 14) | 63 | 70.8 | 56 | 62.2 | p = 0.2249 | 8.56 | −5.20 | 22.33 | |
| V4 (day 28) | 75 | 85.2 | 56 | 63.6 | p = 0.0010 | 21.59 | 9.10 | 34.08 | |
|
| |||||||||
| Troubled sleep (somniloquism) | V1 (day 0) | 12 | 13.5 | 9 | 10.0 | — | — | — | — |
| V2 (days 3–5) | 20 | 22.5 | 14 | 15.6 | p = 0.2382 | 6.92 | −4.54 | 18.37 | |
| V3 (day 14) | 33 | 37.1 | 21 | 23.3 | p = 0.0451 | 13.75 | 0.44 | 27.05 | |
| V4 (day 28) | 46 | 52.3 | 30 | 34.1 | p = 0.0149 | 18.18 | 3.79 | 32.57 | |
|
| |||||||||
| Physical inactivity and slowness of movements after awakenings | V1 (day 0) | 60 | 67.4 | 61 | 67.8 | — | — | — | — |
| V2 (days 3–5) | 62 | 69.7 | 60 | 66.7 | p = 0.6670 | 3.00 | −10.64 | 16.64 | |
| V3 (day 14) | 71 | 79.8 | 63 | 70.0 | p = 0.1317 | 9.78 | −2.85 | 22.40 | |
| V4 (day 28) | 77 | 87.5 | 66 | 75.0 | p = 0.0336 | 12.50 | 1.12 | 23.88 | |
|
| |||||||||
| Restlessness for unknown reason | V1 (day 0) | 23 | 25.8 | 30 | 33.3 | — | — | — | — |
| V2 (days 3–5) | 33 | 37.1 | 31 | 34.4 | p = 0.7131 | 2.63 | −11.40 | 16.67 | |
| V3 (day 14) | 44 | 49.4 | 41 | 45.6 | p = 0.6030 | 3.88 | −10.74 | 18.50 | |
| V4 (day 28) | 57 | 64.8 | 44 | 50.0 | p = 0.0475 | 14.77 | 0.32 | 29.22 | |
|
| |||||||||
| Sleep disorders frequency | V1 (day 0) | 0 | 0.0 | 0 | 0.0 | — | — | — | — |
| V2 (days 3–5) | 2 | 2.3 | 1 | 1.1 | p = 0.5538 | 1.14 | −2.63 | 4.90 | |
| V3 (day 14) | 8 | 9.0 | 1 | 1.1 | p = 0.0159 | 7.88 | 1.55 | 14.20 | |
| V4 (day 28) | 22 | 25.0 | 6 | 6.8 | p = 0.0010 | 18.18 | 7.71 | 28.65 | |
A: data for the one withdrawn child was not replaced for V4 (day 28), B: data for the two withdrawn children were not replaced for V4 (day 28), CL: confidence limit, and χ 2: Chi-square. Intention-to-treat analysis.