MELATONIN & SLEEP STUDIES IN CHILDREN W/ DEVELOPMENTAL DISABILITIES

本研究分为两个部分。第一部分将通过48小时内的唾液样本记录大约60名脆性X综合征(FXS)患者和60名精神发育迟滞患者的褪黑素谱，其中包括Angelman综合征、VelHearoFaces综合征和Smith Magenis综合征，以及包括正常兄弟姐妹在内的正常对照组。这些患者将从墨尔本、里尔、法国、NIH和丹佛等参与中心招募。这项研究的第二部分是一个为期三年的项目，旨在评估褪黑素与安慰剂在治疗FXS或其他精神发育迟滞患者睡眠障碍方面的疗效。这包括两周的基线运行与四周的治疗，褪黑素或安慰剂，这是交叉的第二个四周的时期。睡眠日记将被用来记录觉醒，唾液褪黑素水平将每隔两周测量一次，以记录服药后的依从性和峰值水平。患者将在丹佛和上面提到的其他中心登记。

This study has two parts. The first part will document the melatonin profile by saliva samples in a 48 hour period in approximately 60 patients (aged 3 to 21 years) with fragile X syndrome (FXS) and 60 controls with mental retardation including those with Angelman syndrome, Velocardiofacial syndrome, and Smith Magenis syndrome in addition to normal controls including normal siblings. These patients will be enrolled from participating centers including Melbourne, Lille, France, NIH and Denver. The second part of the study is a three year project to evaluate the efficacy of melatonin compared to placebo in the treatment of sleep disturbances in patients with FXS or other causes of mental retardation. This involves a two week baseline run in with four weeks of treatment with either melatonin or placebo which is crossed over for a second four week period. Sleep diaries will be used to document awakenings and saliva melatonin levels will be measured at two week intervals to document compliance and peak levels after an oral dose. Patients will be enrolled in Denver and other centers noted above.