Table 2.
Changes in polysomnographic parameters following 8 weeks of treatment*†(change from baseline; median)
Placebo N = 50 | SXB 4.5 g N = 59 | SXB 6 g N = 49 | SXB 9 g N = 35 | |
---|---|---|---|---|
Total Sleep Time (min) | ||||
1st Half | 0.50 | −0.50 | 2.00 | 3.00 |
2nd Half | −1.75 | 5.00 | 4.50 | 10.50 |
TOTAL | 0.25 | 0.00 | 13.00 | 18.00 |
— | NS | NS | p = 0.049 | |
Total NREM Sleep (min) | ||||
1st Half | −2.75 | −1.50 | 4.00 | 15.50 |
2nd Half | 1.75 | 15.00 | 17.00 | 40.50 |
TOTAL | 2.00 | 10.00 | 24.00 | 51.50 |
— | NS | p = 0.010 | p < 0.001 | |
Total REM Sleep (min) | ||||
1st Half | −0.75 | −1.00 | −3.50 | −5.50 |
2nd Half | 2.00 | −5.00 | −4.50 | −17.00 |
TOTAL | −1.00 | −6.00 | −7.00 | −22.00 |
— | NS | NS | p = 0.026 | |
REM Sleep Latency (min) | ||||
0.00 | −1.00 | −1.50 | 6.00 | |
— | p = 0.521 | p = 0.203 | p = 0.547 | |
Stage 1 Sleep (min) | ||||
1st Half | −2.75 | −3.00 | −5.00 | −7.50 |
2nd Half | 1.25 | −1.50 | −9.50 | −14.00 |
TOTAL | −2.25 | −9.50 | −13.50 | −22.50 |
— | p = 0.086 | p < 0.001 | p < 0.001 | |
Stage 2 Sleep (min) | ||||
1st Half | 1.50 | −1.00 | −5.00 | −4.50 |
2nd Half | 0.25 | 12.00 | 13.50 | 24.00 |
TOTAL | 3.50 | 9.50 | 13.00 | 31.50 |
— | NS | NS | NS | |
Stage 3 and 4 Sleep (min) | ||||
1st Half | −0.25 | 1.00 | 10.00 | 20.50 |
2nd Half | 0.00 | 0.50 | 4.50 | 26.50 |
TOTAL | 0.00 | 3.00 | 21.00 | 52.50 |
— | p = | p < 0.001 | p < 0.001 | |
Wake After Sleep Onset (min) | ||||
1st Half | −0.50 | 0.25 | −0.25 | −1.00 |
2nd Half | −2.00 | −1.50 | −2.75 | −9.50 |
TOTAL | 2.00 | −5.75 | −3.75 | −22.00 |
— | NS | NS | p = 0.052 | |
Sleep Stage Shifts Per Hour | ||||
1st Half | −1.82 | −1.51 | −1.18 | −1.91 |
2nd Half | −0.88 | −0.45 | −0.85 | 0.00 |
AVERAGE | −1.03 | −1.36 | −1.11 | −0.68 |
— | NS | NS | NS | |
Delta Power (microvolts^2/Hz) | ||||
1st Half | 85.42 | 8413.11 | 14624.92 | 25164.43 |
2nd Half | −3538.83 | 7725.27 | 19726.61 | 32951.43 |
AVERAGE | −1102.98 | 7166.20 | 14736.32 | 28796.65 |
— | p = 0.006 | p < 0.001 | p < 0.001 | |
Nocturnal Awakenings | ||||
1st Half | −1.50 | −2.00 | −3.00 | −3.00 |
2nd Half | −0.00 | −3.00 | −5.00 | −9.00 |
TOTAL | −0.50 | −5.00 | −8.00 | −12.00 |
— | NS | p = 0.005 | p = 0.009 |
Statistical significance was established compared to placebo. NS = not significant.
Expressed as medians following transformation of non-normal data.