ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
ROSA-B: Impact of Artificial Light at Night on Brain Health in Midlife Women With Vasomotor Symptom
This randomized, parallel-group study will examine how artificial light exposure during nighttime awakenings affects sleep and brain health in midlife women experiencing vasomotor symptoms, such as hot flashes and night sweats. Participants will be randomly assigned to exposure to either typical indoor-intensity light (approximately 100 lux) or dim light (less than 3 lux) during the night. The study will assess the effects of nighttime light exposure on sleep fragmentation, daytime alertness and sleepiness, stress responses, cognitive and emotional functioning, and daily functioning. It will also explore whether sleep fragmentation helps explain the effects of nighttime light exposure on stress and neuropsychological health. The findings may inform strategies to reduce nighttime light exposure and improve sleep and brain health in women during and after the menopause transition.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Shadab Rahman, PhD, MPH
- 电话号码:617-975-8709
- 邮箱:srahman8@bidmc.harvard.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- peri/postmenopausal females aged 45-65 years with nocturnal VMS
Exclusion Criteria:
- selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Indoor light (~100 lux)
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Participants will be exposed to a controlled artificial-light-at-night condition during the scheduled overnight sleep episode. Light will be delivered using a standardized light source at a predetermined intensity and timing to examine its effects on sleep, brain health, and related physiological outcomes in midlife women with vasomotor symptoms. |
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有源比较器:Dim Light (~5 lux)
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Participants will be exposed to a controlled dim-light condition of approximately 5 lux during the scheduled overnight sleep episode. This condition will serve as the comparator for the artificial-light-at-night condition of approximately 100 lux. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Wake After Sleep Onset
大体时间:Baseline and 2 weeks (end of intervention)
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Wake After Sleep Onset (WASO) is a measure of sleep fragmentation. Participants complete a daily diary each morning for a week where they report how many minutes they think they were awake the previous night after first falling asleep. Nightly WASO collected over 1 week immediately preceding each timepoint are averaged. Higher WASO indicates more sleep disruption. |
Baseline and 2 weeks (end of intervention)
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Number of lapses on the Psychomotor Vigilance Test
大体时间:Baseline and 2 weeks (end of intervention)
|
Number of lapses recorded during the 10-minute Psychomotor Vigilance Test (PVT) is a measure of neurobehavioral alertness. A lapse on the PVT is a response to stimulus >500 msec. A higher number of lapses indicates lower vigilance and greater neurobehavioral impairment. |
Baseline and 2 weeks (end of intervention)
|
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Karolinska Sleepiness Scale
大体时间:Baseline and 2 weeks (end of intervention)
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The Karolinska Sleepiness Scale (KSS) is a measure of self-reported sleepiness, a one-item scale from 1 (very alert) to 9 (sleepy; great effort to keep awake). |
Baseline and 2 weeks (end of intervention)
|
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Resting state stress visual analog scale
大体时间:Baseline and 2 weeks (end of intervention)
|
Self-reported resting state stress is measured using a one-item visual analog scale (VAS) from 0 (Stressed Out) to 100 (Calm/Relaxed). Participants answer the resting state stress VAS each morning upon wake. Daily scores collected over 1 week immediately preceding each timepoint are averaged |
Baseline and 2 weeks (end of intervention)
|
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Change in cortisol
大体时间:2 weeks (end of intervention)
|
Change in cortisol before and after a 20-minute stress task is measured using salivary biosamples. |
2 weeks (end of intervention)
|
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Multi-day learning curve composite score
大体时间:2 weeks (end of intervention)
|
Cognitive function is measured with a multi-day learning curve composite score based on a cognitive assessment that participants complete daily over 1 week preceding the timepoint. The composite score ranges from 0 (no learning) to 1 (optimal learning). |
2 weeks (end of intervention)
|
|
Patient-Reported Outcomes Measurement Information System-Depression Scale
大体时间:Baseline and 2 weeks (end of intervention)
|
The Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS-D) is a self-report short-form to assess depressive symptoms. A higher score indicates more depressive symptoms. |
Baseline and 2 weeks (end of intervention)
|
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WHODAS 2.0 daily functioning score
大体时间:Baseline and 2 weeks (end of intervention)
|
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 36-item self-report questionnaire to assess daily functioning. The score ranges from 0 (no disability) to 100 (full disability). |
Baseline and 2 weeks (end of intervention)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026P000461
- 2U54AG062322-06 (美国 NIH 拨款/合同)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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