Circadian Amplification in Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Sleep
研究概览
简要总结
This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The outcomes of interest are objective and subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring
详细描述
This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The two main components of the intervention are timed light exposure and weekly remote coaching session by psychologist to optimize circadian and sleep behaviors. The outcomes of interest are objective and subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •a history of at least moderate non-proliferative diabetic retinopathy
- •would like to improve sleep
- •own a smartphone compatible with fitbit.
排除标准
- •Use of melatonin
- •Use of antipsychotics
- •Use of more than one antidepressant. The dose of which needs to be stable for 6 weeks.
- •illicit drug use
- •night shift work or travel beyond 2 time zones in the month before enrollment
- •end stage renal disease requiring renal replacement therapy
- •history of stroke or transient ischemic attacks
- •history of dementia or memory impairment
- •uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
- •chronic obstructive pulmonary disease requiring oxygen
- •severe chronic liver disease such as cirrhosis
- •ongoing treatment for major medical problems such as cancer
- •history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
- •Regular use of sedatives and hypnotics (>2 times/ month).
- •clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
- •Significant depressive symptoms as assessed by PHQ-8 questionnaire (score >14)
- •No health insurance coverage
- •History of untreated severe OSA.
- •Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- •Uncontrolled diabetes (A1C ≥ 11%)
结局指标
主要结局
Sleep
时间窗: baseline and 6-week
Objective and Subjective Sleep Parameters
次要结局
- Salivary melatonin and cortisol(baseline and 6-week)
- Glucose levels(baseline and 6-week)