Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Change in Dim Light Melatonin Onset (DLMO) Phase Shift
研究概览
简要总结
The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST) and an advance in sleep onset times (shift earlier) compared to the control group.
详细描述
We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders [ICSD-3] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Dim Light Melatonin Onset (DLMO) Phase Shift
时间窗: baseline, week 2
The time in hours the circadian clock shifted the sleep onset time. Using a light lux meter, the lighting in the room will be limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.
Change in Dim Light Melatonin Onset (DLMO)
时间窗: baseline, week 3
The time of day the subject feels sleepy during the overnight lab stays. It is a marker of biological time. Data are provided in decimal and military time (e.g., 10:00 pm equals 22.00). Using a light lux meter, the lighting in the room was limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.
Change in School Night Sleep Onset Time
时间窗: baseline, week 3
The time in hours that sleep onset time shifted earlier during school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.
Change in Non-school Night Sleep Onset Time
时间窗: baseline, week 3
The time in hours that sleep onset time shifted earlier during non-school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.
次要结局
未报告次要终点
研究者
R. Robert Auger
Principal Investigator
Mayo Clinic