MELATONIN & SLEEP STUDIES IN CHILDREN W/ DEVELOPMENTAL DISABILITIES

褪黑素

• 批准号: 6305033
• 负责人: RANDI J. HAGERMAN
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6305033
• 关键词: adolescence (12-20); cleft palate; clinical research; drug screening /evaluation; fragile X syndromes; happy puppet syndrome; hormone therapy; human subject; human therapy evaluation; longitudinal human study; melatonin; mental retardation; middle childhood (6-11); oral administration; personal log /diary; preschool child (1-5); saliva; sample collection; siblings; sleep disorders; therapy compliance; wakefulness; young adult human (21-34)

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.

本研究分为两部分。 第一部分将通过唾液样本记录褪黑激素分布，在48小时内，在大约60名脆性X综合征（FXS）患者（年龄3至21岁）和60名智力迟钝的对照组中，包括Angelman综合征、Velocardiofacial综合征和Smith Magenis综合征，以及正常对照组（包括正常同胞）。 这些患者将从参与中心入组，包括墨尔本、里尔、法国、NIH和丹佛。该研究的第二部分是一个为期三年的项目，以评估褪黑激素与安慰剂相比在治疗患有FXS或其他精神发育迟滞原因的患者的睡眠障碍方面的疗效。 这涉及两周的基线运行与用褪黑激素或安慰剂治疗的四周，其交叉进行第二个四周时期。睡眠日记将用于记录觉醒，唾液褪黑激素水平将每隔两周测量一次，以记录口服剂量后的依从性和峰值水平。 患者将在丹佛和上述其他中心入组。