Bright Light Therapy to Reduce Sleep Disturbance and Biological Aging in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change from Baseline in sleep patterns at 4 weeks
研究概览
简要总结
The goal of this randomized intervention trial is to determine the effect of bright light therapy on sleep disturbance, as well as to investigate the impacts of bright light therapy on biological age measured by clinical biomarkers. The main questions it aims to answer are:
- Does bright light therapy improve sleep patterns (i.e., sleep onset latency, sleep disturbance, and sleep efficiency) in lung cancer patients?
- Can bright light therapy slow the rate of aging measured by biological age in lung cancer patients? Researchers will compare bright light therapy group to control group to see if bright light works to reduce sleep disturbance and decelerate biological aging.
Participants will:
- Receive bright light exposure or usual light exposure every day for 4 weeks
- Get blood draw at the baseline and at 4 weeks for clinical biomarkers tests
- Complete self-reported sleep, fatigue and stress surveys at the baseline and at 4 weeks
- Keep a daily sleep log
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=18 years of age
- •Stage Ib to IIIb primary lung cancer diagnosis
- •>=2 months after completion of primary therapy, patient can continue to be on maintenance/immunotherapy
- •ECOG performance status is 0 or 1
- •Experience problematic sleep (scores of >=8 on the Insomnia Severity Index)
- •Able to understand, speak, and read English
- •Sighted and mentally competent to consent
排除标准
- •Pregnant women
- •Have metastatic cancer
- •on oxygen therapy
- •Current diagnosis of seasonal affective disorder or substance abuse
- •Engage in shift work or travel across >3 time zones within 2 weeks prior to the study
- •Are currently being treated for sleep apnea, restless legs syndrome, or narcolepsy
- •Take prescribed sedative hypnotics or antipsychotics
- •Have eye conditions (glaucoma or retinal disease), problem triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents)
- •Participants with an Insomnia Severity Index <8
- •Participants with cognitive impairment (sores of <3 mini-cog test)
研究组 & 干预措施
bright light arm
Participants will receive a daily 30-minutes bright light through light visor for 4 weeks.
干预措施: bright light (Other)
control arm
Participants will not receive bright light, and keep their usual daily light exposure for 4 weeks.
结局指标
主要结局
Change from Baseline in sleep patterns at 4 weeks
时间窗: from enrollment to the end of the intervention at 4 weeks
Changes in sleep patterns will be assessed by sleep efficiency (e.g., duration of sleep in hours), sleep quality (e.g., number of sleep disturbance), and sleep onset latency (e.g., minutes of falling asleep).
Changes from baseline in the measures of biological age at 4 weeks
时间窗: From enrollment to the end of intervention at 4 weeks
Participants have a lower rate of biological aging
次要结局
- Change from Baseline in the measure of fatigue and stress at 4 weeks(From enrollment to the end of intervention at 4 weeks)
研究者
Menghua Tao
Assistant Scientist
Henry Ford Health System
