抄録
Objective: To investigate the association between subjective sleep latency (sSL) fluctuation during the lead-in period and the placebo response in the subsequent double-blind period. Methods: The current study is a secondary analysis of data from the placebo arm (380 patients) of a double-blind study in outpatients with primary insomnia. Results: Higher fluctuation of lead-in sSL was associated with a greater decrease in sSL in the subsequent weeks. Multivariate analysis suggested that a wider standard deviation for daily sSL and a higher weekly mean sSL during the lead-in period were independent predictors of greater improvement in mean sSL during the subsequent weeks of placebo treatment. Likewise, a wider standard deviation and lower mean of subjective total sleep time (sTST) during the lead-in period were independent predictors of greater improvement in mean sTST in the subsequent weeks, but predictability of change in sTST with these parameters appears lower than those for sSL (R2=0.13 and 0.44, respectively, in Week 2). Conclusions: The importance of night-to-night variability of sSL in sleep assessment is highlighted. Excluding patients with high variability of lead-in sSL should be considered in clinical studies evaluating an effect on sleep onset, especially in the early stages of clinical development.
本文言語 | English |
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ページ(範囲) | 565-571 |
ページ数 | 7 |
ジャーナル | Sleep Medicine |
巻 | 12 |
号 | 6 |
DOI | |
出版ステータス | Published - 2011 6月 |
外部発表 | はい |
ASJC Scopus subject areas
- 医学(全般)