Prolonged release melatonin for improving sleep in totally blind subjects: a pilot placebo-controlled multicenter trial.
作者： Nava Zisapel , Tali Nir , Thomas Roth
DOI: 10.2147/NSS.S71838
关键词:
摘要: Introduction Melatonin, secreted by the pineal gland during night phase, is a regulator of biological clock and sleep tendency. Totally blind subjects frequently report severe, periodic problems, with 50%–75% cases displaying non-24-hour sleep–wake disorder (N24HSWD) due to inability synchronize environmental day–night cycle. Melatonin immediate-release preparations are reportedly effective in N24HSWD. Here, we studied efficacy safety prolonged-release melatonin (PRM), registered drug for insomnia, disorders totally living normal social environments. The primary endpoint was demonstration clinically meaningful effects on duration (upper confidence interval [CI] limit >20 minutes whether significant or not) allow early decision-making further development this indication.
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