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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
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BMC Medicine

ISSN: 1741-7015

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