Individually Tailored Lighting System to Improve Sleep in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Sleep Disturbance
研究概览
简要总结
In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later
详细描述
We will recruit 50 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 2-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 65 or older
- •cognitively capable
- •able to respond to study staff verbally and in English
- •score greater than 6 using the Pittsburgh Sleepiness Quality Index
- •suffer from insomnia
- •suffer from excessive daytime sleepiness
排除标准
- •Severe sleep apnea
- •Severe restless leg syndrome (RLS)
- •Significant cognitive impairment
- •History of severe photosensitivity dermatitis
研究组 & 干预措施
Blue light
The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two blue Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the blue light mask was worn nightly for 8 weeks. There will be a two week washout period between each intervention
干预措施: Blue light (Other)
Red light
The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two red Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the red light mask was worn nightly for 8 weeks, with a two week washout period between each intervention
干预措施: Red light (Other)
结局指标
主要结局
Sleep Disturbance
时间窗: Baseline (week 0) and week 8 of lighting intervention
Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome.
Sleep Start Time
时间窗: baseline week (week 0) and the last week of intervention (week 8)
Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data
Total Sleep Time
时间窗: baseline week (week 0) and the last week of intervention (week 8)
The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome
Sleep Efficiency
时间窗: baseline week (week 0) and the last week of intervention (week 8)
The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.
次要结局
未报告次要终点
研究者
Mariana G Figueiro
Professor
Rensselaer Polytechnic Institute