A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Global Impression- Improvement (CGI-I)
研究概览
简要总结
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
详细描述
This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis.
Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 88 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PWS confirmed by genetic testing
- •Score of 12 or above on the Epworth Sleepiness Scale (ESS).
排除标准
- •Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications
- •A history of previous treatment with LT
- •Patients presenting with active psychosis or mania
研究组 & 干预措施
Light Therapy
干预措施: Bright Light Therapy (Other)
Sham Light
干预措施: Sham Light (Other)
结局指标
主要结局
Clinical Global Impression- Improvement (CGI-I)
时间窗: 8 Weeks
A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.
次要结局
- Modified Overt Aggression Scale(8 Weeks)
- Aberrant Behavior Checklist(8 Weeks)
- Self-Injury Trauma scale(8 Weeks)