A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Aim 1a
概览
简要总结
The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.
详细描述
The hypothesis of this study is that morning bright light therapy (BLT) using Re-Timer™ glasses in irritable bowel syndrome (IBS) patients with circadian misalignment (CM), will improve IBS symptom severity, improve circadian misalignment, decrease intestinal permeability and improve stool microbial diversity. Our overall objective is to assess the effects of morning bright light therapy on IBS symptom severity, circadian misalignment, intestinal permeability and intestinal microbiota. We propose to conduct a 6-week, single center, randomized, crossover pilot trial involving 30 subjects with active IBS symptoms (IBS-SSS >75), and circadian misalignment (CM) based on late chronotype (Munich Chronotype Questionnaire, Corrected Midpoint of Sleep > 4:00h). Subjects will be randomized to BLT or placebo with a 2-week washout between each condition. All subjects will have assessments at two timepoints: after 2 weeks of BLT, and after 2 weeks of placebo.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Irritable Bowel Syndrome based on Rome IV diagnostic criteria
- •Mild to severe IBS symptom severity based on IBS-SSS greater than or equal to 75
- •Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep \> 4:00h) 18
排除标准
- •Subject that are pregnant or plan to become pregnant.
- •Night shift workers or people who have crossed more than 2 time zones in the previous 4 weeks.
- •Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, antibiotics, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study.
- •Any major organ disease - known renal impairment, diabetes, liver disease, or significant cardiac failure (NY classification stage III/IV), inflammatory bowel disease or celiac disease per chart review and/or medical history.
- •Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening.
- •Moderate to severe depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression Inventory) 19
- •Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) 20
- •Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale) 21
- •Inability or unwillingness of subject to sign an informed consent
研究组 & 干预措施
Re-Timer Device (Bright Light Therapy)
Morning bright light therapy will be administrated through a safe wearable device called a Re-timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light. The device emits light at a higher wavelength than the UV range and has a UV filter for added safety. Subjects will be asked to wear the glasses for one hour each morning per day for 7 days a week. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).
干预措施: Re-Timer glasses (Device)
Placebo device (non Bright Light Therapy)
Subjects will be asked to wear glasses that do not provide Bright Light Therapy for one hour each morning per day for 7 days a week as recommended by the manufacturer. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).
干预措施: Placebo Device (Device)
结局指标
主要结局
Aim 1a
时间窗: 2 weeks of morning Bright Light Therapy (BLT)
In Aim 1a, we predict 2 weeks of morning BLT in IBS subjects with CM will improve IBS-symptom severity based on the IBS Severity Scoring Scale as compared to the control (wear the Re-Timer™ glasses without light therapy).
Aim 1b
时间窗: 2 weeks of morning Bright Light Therapy (BLT)
In Aim 1b, we predict 2 weeks of morning BLT will improve circadian misalignment as accessed by wrist actigraphy (interdaily stability, intradaily variability, and relative amplitude).
次要结局
- Aim 2(2 weeks of morning Bright Light Therapy (BLT))