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Table 1 Primary, secondary, and explorative objectives and related endpoints and assessments

From: Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial

  Objective Endpoint Assessment method
Primary To study the short-time effectiveness of zopiclone on patient-reported subjective sleep quality Patient-reported sleep quality the last study night (night 6) Numerical rating scale 0–10, 0 = Best sleep, 10 = Worst possible sleep
Secondary To study the short-time effectiveness of zopiclone on patient-reported TST Patient-reported TST (minutes) the last study night (night 6) Sleep diary
To study the short-time effectiveness of zopiclone on patient-reported SOL Patient-reported SOL (minutes) the last study night (night 6) Sleep diary
Explorative To study the short-time effectiveness of zopiclone on overall patient-reported sleep quality Patient-reported overall sleep quality over a week time interval Pittsburgh Sleep Quality Index
To study the short-time effectiveness of zopiclone on objectively measured TST, SOL, SE, WASO, and NWAK TST (minutes), SOL (minutes), SE (percent), WASO and NWAK during the last study night (night 6) Actigraphy
To study the short-time effectiveness of zopiclone on patient-reported TST, SOL, SE, WASO, and NWAK TST (minutes), SOL (minutes), SE (percent), WASO, and NWAK during the last study night (night 6) Sleep diary
To study the short-time effectiveness of zopiclone on self-reported daytime sleepiness Daytime sleepiness in the morning after night 6 Karolinska Sleepiness Scale
  1. TST total sleep time, SOL sleep onset latency, SE sleep efficiency, WASO wake after sleep onset, NWAK number of awakenings