NCT02180451Unknown不适用
Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 主要终点
- Circadian analytes rhythms as measured in plasma
研究概览
简要总结
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed clinical diagnosis of SMS with a prior positive genetic test result as indicated by a parent/guardian
- •Informed consent from the patient or the legal guardian/assent provided by the individual with SMS, when possible
- •Male or female between the ages of 6-50 years of age
- •History of sleep disturbances
- •Willing and able to comply with study requirements and restrictions
排除标准
- •Failure to confirm diagnosis of SMS by molecular cytogenetic methods and/or DNA-based mutation analysis of the RAI1 gene
- •Totally blind with no light perception
- •Institutionalized or living in an assisted living facility
- •Unwilling or unable to follow medication restrictions (medications that affect sleep or melatonin secretion) or unwilling or unable to sufficiently wash-out from use of a restricted medication
- •Any medical condition, as determined by the clinical investigator that would make it unsafe for blood draws (e.g., anemia, blood clotting disorders, anxiety, etc.)
- •Any other sound medical reason as determined by the clinical investigator
结局指标
主要结局
Circadian analytes rhythms as measured in plasma
时间窗: 36-hour blood sampling at week 4
Circadian melatonin rhythm as measured by plasma melatonin
时间窗: 36-hour blood sampling on week 4
Circadian cortisol rhythms as measured by plasma cortisol
时间窗: 36-hour blood sampling at week 4
次要结局
- Nighttime and daytime sleep as measured by actigraphy(Four week evaluation period)
- Genetic testing to confirm SMS diagnosis(blood sampling at screening visit)
- Melatonin Light Response Test (MLRT)(After four week evaluation period)
- Behavioral Scale(Four week evaluation period)
- QOL Scale(Four week evaluation period)
- Salivary melatonin and cortisol(Four week evaluation period)
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