CLINICAL TRIAL: TREATMENT OF SLEEP PROBLEMS IN CHILDREN WITH AUTISM SPECTRUM DI

临床试验：自闭症谱系障碍儿童睡眠问题的治疗

• 批准号: 8356687
• 负责人: BOBBI HOPKINS
• 金额: $ 1.62万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356687
• 关键词: Affect; Age; Autistic Disorder; Behavior; Behavioral; Child; Circadian Rhythms; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Cognitive; Development; Diagnostic tests; Disease; Dose; Double-Blind Method; Effectiveness; Evaluation; Exposure to; Family; Functional disorder; Funding; Future; Gastroesophageal reflux disease; Grant; Hormones; Hour; Intervention; Matched Group; Measures; Medical; Melatonin; National Center for Research Resources; Oral; Outcome Measure; Parents; Participant; Pharmaceutical Preparations; Placebos; Play; Principal Investigator; Production; Quality of life; Questionnaires; Recruitment Activity; Research; Research Infrastructure; Resources; Role; Salivary; Sampling; Severities; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleep disturbances; Sleeplessness; Source; Symptoms; United States National Institutes of Health; Urine; actigraphy; autism spectrum disorder; cost; experience; hypnotic; improved; primary outcome; randomized trial; treatment trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT We propose to examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the secretion of melatonin (MT), a hormone that plays an important role in regulating the circadian cycle and sleep. Furthermore, we will examine the efficacy of MT for improving sleep in children with ASD. Children with ASD experience high rates of sleep disturbances that potentially contribute to the severity of their cognitive and behavioral dysfunction and to poor quality of life for themselves and their families. It is unclear if irregularities in MT rhythm underlie sleep problems in children with ASD. Their sleep problems are characterized by sleep-wake rhythm abnormalities and symptoms of insomnia including difficulty initiating and maintaining sleep. MT is frequently used to treat these sleep problems; however, its effectiveness as a hypnotic to treat insomnia in children with ASD has not been clearly established. All subjects will be recruited from the Autism Treatment Network after completing rigorous diagnostic testing. Exclusionary criteria include exposure to melatonin in the month prior to the study, current psychoactive medications or medications known to suppress MT secretion, other sleep disorders, such as sleep apnea, and medical disorders that may affect sleep, such as gastroesophageal reflux disease (GERD). Participants parents will complete a validated sleep questionnaire, which will define the presence or absence of sleep problems. MT onset will be determined by measuring salivary MT levels before and after usual bedtime in ASD children with sleep problems and in a matched group of children with ASD and no sleep problems. Total 24 hour MT production will be determined from urine samples in these same two groups. A double-blind, randomized trial of three oral doses of MT (3, 6, 9 mg) and placebo in children (ages 4-9 years) with ASD and sleep problems will follow a baseline sleep and behavior evaluation. The primary outcome measure will be change in sleep latency as determined by actigraphy at baseline and at the end of the fifth week of each of the treatment trials. Another primary outcome measure will be change in validated behavioral questions given at baseline and during the fifth week of each of the treatment trials. Results from this study will provide a rationale for the development of future trials of circadian rhythm interventions and clinical parameters for the use of MT to manage sleep problems in ASD.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 抽象的 我们建议检查自闭症谱系障碍儿童（ASD）的睡眠问题是否与褪黑激素（MT）的分泌改变有关，这是一种在调节昼夜节律周期和睡眠中起重要作用的激素。此外，我们将研究MT改善ASD儿童睡眠的功效。 ASD患者的睡眠障碍率很高，可能导致其认知和行为功能障碍的严重性以及对自己和家人的生活质量差。 目前尚不清楚ASD儿童的睡眠问题是MT节奏的违规行为。他们的睡眠问题的特征是睡眠节奏的节奏异常和失眠症状，包括难以发起和维持睡眠。 MT经常用于治疗这些睡眠问题；但是，它作为催眠治疗ASD儿童失眠的有效性尚未清楚地确​​定。 完成严格的诊断测试后，将从自闭症治疗网络中招募所有受试者。 排他性标准包括在研究前一个月接触褪黑激素，当前的精神活性药物或已知可抑制MT分泌的药物，其他睡眠障碍，例如睡眠呼吸暂停以及可能影响睡眠的医学疾病，例如胃食管反流疾病（GERD）。 参与者父母将完成经过验证的睡眠问卷，这将定义睡眠问题的存在或不存在。 MT发作将通过在患有睡眠问题的ASD儿童以及与ASD且无睡眠问题的匹配的儿童组中测量通常睡前和之后的唾液MT水平来确定。总共24小时MT的产生将从这两组中的尿液样本中确定。三种口服剂量的MT（3、6、9毫克）和安慰剂的双盲，随机试验（4-9岁）的ASD和睡眠问题将遵循基线睡眠和行为评估。主要结局指标将是在基线和每个治疗试验的第五周结束时由Actraphy确定的睡眠潜伏期的变化。另一个主要的结果指标将是在基线和每个治疗试验的第五周中给出的经过验证的行为问题变化。 这项研究的结果将为开发未来的昼夜节律干预措施和临床参数的试验提供基本原理，用于使用MT来管理ASD中的睡眠问题。