The Effects of Morning Light Therapy on IBD Activity and Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- C-reactive protein (CRP) level
研究概览
简要总结
The pilot study will focus on the effects of morning light therapy (MLT) in adult patients with ulcerative colitis (UC) who have evidence of poor sleep quality and active inflammation. The specific population is at risk for circadian rhythm sleep-wake disorders and has significant potential benefit from circadian realignment, which may lead to improved sleep quality and, ultimately, UC-related inflammatory activity. During an initial one-week lead-in period, participants will obtain baseline circadian-related labs, complete symptom-related surveys, and use a wearable device continuously to obtain baseline sleep-wake data. After the lead-in week, patients will undergo one hour of MLT while wearing wearable devices continuously and completing daily symptom surveys. At the end of four weeks of MLT, patients will obtain post-intervention circadian and inflammatory assessments in addition to completing the same symptom-related surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin >150 mcg/g and/or CRP >5)
排除标准
- •Known pregnancy or currently lactating women
- •Current malignancy or active treatment for previously diagnosed malignancy. Patients with squamous and basal cell cancer of the skin are eligible for the study.
- •Serious co-morbidity including: Immunodeficiency, recent myocardial infarction or stroke, history of renal or hepatic failure, infection such as abscess, opportunistic infection, or sepsis.
- •Patients with pacemaker or defibrillators
- •The use of medications known to affect autonomic nervous system function, including but not limited to beta-blockers and benzodiazepines.
- •Comprehension of the English language not adequate to understand the questionnaires
- •Recent changes in IBD directed therapies within the last 3 months
- •Regular use of antidiarrheal agents.
- •Regular use of medications that have been shown to impair sleep (e.g. steroids, stimulants). If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolled in the study
- •Regular use of sleep medications including but not limited to: benzodiazepine hypnotics, non-benzodiazepine hypnotics, antipsychotics, and melatonin. If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolled in the study
- •Patients with prior colectomy or total proctocolectomy
- •History of any surgery within 3 months
- •Untreated Obstructive Sleep Apnea
- •Blindness or severely impaired, uncorrected vision
- •Employment which includes nocturnal shift work
- •Traveling multiple time zones within the study time frame
- •Any marijuana or illicit drugs use within one month of enrollment or ongoing basis
研究组 & 干预措施
Adult patients with Ulcerative Colitis (UC)
Adult patients with ulcerative colitis (UC)
干预措施: Morning Light Therapy (Device)
结局指标
主要结局
C-reactive protein (CRP) level
时间窗: week 4
C-reactive protein (CRP) is produced by the liver. The CRP test is a general test to check for inflammation in the body.
Fecal Calprotectin (FCP)
时间窗: week 4
The fecal calprotectin is a stool test which measures intestinal inflammation.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS 10)(week 4)
- Change in Microbiome composition(week 4)
- Change in Morning urine melatonin level(week 4)
研究者
Robert Hirten
Associate Professor
Icahn School of Medicine at Mount Sinai