Night-to-night variability of sleep latency significantly predicts the magnitude of subsequent change in sleep latency during placebo administration

Atsushi Ogawa, Shiro Hinotsu, Hisashi Urushihara, Koji Kawakami

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)565-571
Number of pages7
JournalSleep Medicine
Volume12
Issue number6
DOIs
Publication statusPublished - 2011 Jun
Externally publishedYes

Fingerprint

Sleep
Placebos
Sleep Initiation and Maintenance Disorders
Double-Blind Method
Outpatients
Multivariate Analysis

Keywords

  • Clinical trial
  • Fluctuation
  • Insomnia
  • Placebo effects
  • Sleep latency
  • Variability

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Night-to-night variability of sleep latency significantly predicts the magnitude of subsequent change in sleep latency during placebo administration. / Ogawa, Atsushi; Hinotsu, Shiro; Urushihara, Hisashi; Kawakami, Koji.

In: Sleep Medicine, Vol. 12, No. 6, 06.2011, p. 565-571.

Research output: Contribution to journalArticle

@article{a8c6cd51f9d14da7adf4580e9d446921,
title = "Night-to-night variability of sleep latency significantly predicts the magnitude of subsequent change in sleep latency during placebo administration",
abstract = "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.",
keywords = "Clinical trial, Fluctuation, Insomnia, Placebo effects, Sleep latency, Variability",
author = "Atsushi Ogawa and Shiro Hinotsu and Hisashi Urushihara and Koji Kawakami",
year = "2011",
month = "6",
doi = "10.1016/j.sleep.2011.03.009",
language = "English",
volume = "12",
pages = "565--571",
journal = "Sleep Medicine",
issn = "1389-9457",
publisher = "Elsevier",
number = "6",

}

TY - JOUR

T1 - Night-to-night variability of sleep latency significantly predicts the magnitude of subsequent change in sleep latency during placebo administration

AU - Ogawa, Atsushi

AU - Hinotsu, Shiro

AU - Urushihara, Hisashi

AU - Kawakami, Koji

PY - 2011/6

Y1 - 2011/6

N2 - 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.

AB - 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.

KW - Clinical trial

KW - Fluctuation

KW - Insomnia

KW - Placebo effects

KW - Sleep latency

KW - Variability

UR - http://www.scopus.com/inward/record.url?scp=79958000143&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79958000143&partnerID=8YFLogxK

U2 - 10.1016/j.sleep.2011.03.009

DO - 10.1016/j.sleep.2011.03.009

M3 - Article

VL - 12

SP - 565

EP - 571

JO - Sleep Medicine

JF - Sleep Medicine

SN - 1389-9457

IS - 6

ER -