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.

该子项目是利用资源的众多研究子项目之一 由 NIH/NCRR 资助的中心拨款提供。子项目的主要支持 并且子项目的首席研究员可能是由其他来源提供的， 包括其他 NIH 来源。 子项目可能列出的总成本 代表子项目使用的中心基础设施的估计数量， NCRR 赠款不直接向子项目或子项目工作人员提供资金。 抽象的 我们建议检查自闭症谱系障碍 (ASD) 儿童的睡眠问题是否与褪黑激素 (MT) 分泌的改变有关，褪黑激素 (MT) 是一种在调节昼夜节律和睡眠中发挥重要作用的激素。此外，我们将研究 MT 对于改善 ASD 儿童睡眠的功效。患有自闭症谱系障碍的儿童睡眠障碍的发生率很高，这可能会导致他们严重的认知和行为功能障碍，并导致他们自己和家人的生活质量下降。 目前尚不清楚 MT 节律不规则是否是 ASD 儿童睡眠问题的根源。他们的睡眠问题的特点是睡眠-觉醒节律异常和失眠症状，包括难以启动和维持睡眠。 MT 经常用于治疗这些睡眠问题；然而，其作为催眠药治疗自闭症儿童失眠的有效性尚未明确。 所有受试者在完成严格的诊断测试后都将从自闭症治疗网络招募。 排除标准包括在研究前一个月接触褪黑激素、当前服用精神活性药物或已知抑制 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内科疾病（例如胃食管反流病 (GERD)） 。 参与者家长将完成一份经过验证的睡眠调查问卷，该调查问卷将确定是否存在睡眠问题。 MT 的发作将通过测量有睡眠问题的 ASD 儿童和匹配的患有 ASD 但没有睡眠问题的儿童在正常就寝时间之前和之后的唾液 MT 水平来确定。 24 小时 MT 总产量将根据这两组的尿样确定。对患有自闭症谱系障碍 (ASD) 和睡眠问题的儿童（4-9 岁）进行三种口服剂量的 MT（3、6、9 毫克）和安慰剂的双盲、随机试验，随后将进行基线睡眠和行为评估。主要结果指标是睡眠潜伏期的变化，通过基线和每个治疗试验第五周结束时的体动记录仪确定。另一个主要结果指标是在基线和每次治疗试验的第五周期间给出的经过验证的行为问题的变化。 这项研究的结果将为未来开发昼夜节律干预试验和使用 MT 管理 ASD 睡眠问题的临床参数提供依据。