NCT05373979已完成不适用
Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Survey Validation
研究概览
简要总结
The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.
详细描述
WHO IS ELIGIBLE?
- Children and adolescents with narcolepsy between the ages of 9-17 years
- Diagnosis must be verified by a signed letter from physician in order to participate
- Participants must be able to understand the purpose of the study
PARTICIPATION DETAILS
- Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.
- One week later, some participants will receive another email with a link to complete a 10-minute follow up survey
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents ages 9-17
- •Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)
排除标准
- •A history of visual or hearing impairment
- •A co-morbid neurodevelopmental disorder such as autism or schizophrenia
- •No access to computer/tablet/smart phone to complete questionnaires
结局指标
主要结局
Survey Validation
时间窗: 2 Years
To evaluate the content validity and reliability of the PN-PROs item pools through a field test of the item pools in a diverse, national sample of pediatric narcolepsy patients with a comparator group of pediatric mild obstructive sleep apnea patients (9-17 years).
次要结局
未报告次要终点
研究者
Kiran Maski
Principal Investigator
Boston Children's Hospital
研究点 (1)
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