ROSA-B: Impact of Artificial Light at Night on Brain Health in Midlife Women With Vasomotor Symptom
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Wake After Sleep Onset
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •peri/postmenopausal females aged 45-65 years with nocturnal VMS
排除标准
- •selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities
研究组 & 干预措施
Indoor light (~100 lux)
干预措施: Artificial Light at Night (ALAN) 100 lux (Behavioral)
Dim Light (~5 lux)
干预措施: Artificial Light at Night (ALAN) Dim Light (Behavioral)
结局指标
主要结局
Wake After Sleep Onset
时间窗: Baseline and 2 weeks (end of intervention)
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.
Number of lapses on the Psychomotor Vigilance Test
时间窗: 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.
Karolinska Sleepiness Scale
时间窗: Baseline and 2 weeks (end of intervention)
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).
Resting state stress visual analog scale
时间窗: 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
Change in cortisol
时间窗: 2 weeks (end of intervention)
Change in cortisol before and after a 20-minute stress task is measured using salivary biosamples.
Multi-day learning curve composite score
时间窗: 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).
Patient-Reported Outcomes Measurement Information System-Depression Scale
时间窗: 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.
WHODAS 2.0 daily functioning score
时间窗: 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).
次要结局
未报告次要终点
研究者
Shadab Rahman
Assistant Professor of Psychiatry
Beth Israel Deaconess Medical Center