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