A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
概览
- 阶段
- 不适用
- 干预措施
- Sham Light
- 疾病 / 适应症
- Prader-Willi Syndrome
- 发起方
- Maimonides Medical Center
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Global Impression- Improvement (CGI-I)
- 状态
- 招募中
- 最后更新
- 8天前
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.
研究者
入排标准
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
Sham Light
干预措施: Sham Light
Light Therapy
干预措施: Bright Light Therapy
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)