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Table 6 Sleep Diary parameters in the 65-80 age group.

From: Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

     Treatment effects
   Change from baseline Mean (SD) Short term Long term *
   Visit 3 Visit 7 Estimate (95% CI) P -value Estimate (95% CI) P -value
NMAX PRM 137 159   
  Placebo 144 61   
Sleep latency PRM -19.1 (47.3) -25.9 (46.4) -15.6 (-25.3, -6.0) -14.5 (-21.4, -7.7)
(min) Placebo -1.7 (47.8) -8.3 (61.5) P = 0.002 P < 0.001
Sleep PRM -0.24 (0.80) -0.31 (0.94) -0.17 (-0.33, 0.00) -0.09 (-0.22, 0.03)
maintenance Placebo -0.09 (0.78) -0.20 (0.70) P = 0.046 P = 0.148
Total sleep PRM 0.34 (0.75) 0.64 (0.99) 7.0 (-3.4, 17.4) 7.5 (-0.7, 15.7)
time (h) Placebo 0.20 (0.79) 0.41 (1.06) P = 0.186 P = 0.073
Sleep onset PRM -0.22 (0.80) -0.41 (0.75) -0.22 (-0.39, -0.05) -0.21 (-0.33, -0.08)
(hours) Placebo 0.00 (0.71) -0.12 (1.06) P = 0.012 P = 0.002
Sleep offset PRM 0.03 (0.81) 0.03 (0.84) -0.16 (-0.33, 0.02) -0.12 (-0.24, 0.00)
(h) Placebo 0.19 (0.79) 0.21 (0.91) P = 0.076 P = 0.051
Refreshed on PRM -0.10 (0.36) -0.22 (0.42) 0.00 (-0.08, 0.08) -0.06 (-0.12, 0.00)
waking Placebo -0.09 (0.37) -0.11 (0.42) P = 0.994 P = 0.053
Morning PRM -0.18 (0.52) -0.36 (0.69) -0.04 (-0.16, 0.07) -0.10 (-0.19, -0.01)
alertness Placebo -0.11 (0.51) -0.09 (0.60) P = 0.453 P = 0.032
  PRM -0.20 (0.56) -0.39 (0.71) -0.06 (-0.19, 0.07) -0.08 (-0.18, 0.01)
Sleep quality Placebo -0.12 (0.57) -0.17 (0.54) P = 0.356 P = 0.082
  1. Mean (SD) changes from baseline at Visits 3 and 7, with estimates of short-term treatment effect (linear regression model, adjusted for baseline value and age) and long-term treatment effect (mixed effects regression model, adjusted for baseline value, age and visit; global treatment effect reported)
  2. Mean (standard deviation; SD) changes from baseline at Visits 3 and 7, with estimates of short-term treatment effect (linear regression model, adjusted for baseline value and age) and long-term treatment effect (mixed effects regression model, adjusted for baseline value, age and visit; global treatment effect reported)
  3. *Global treatment effect is estimated using a mixed-effect model for repeated measures and takes into account the treatment effect difference over the 26-weeks (at Visits 3, 4, 5, 6 and 7) sleep latency (diary data) are repeated for completeness.
  4. CI, confidence interval