IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Short IBD Questionnaire (SIBDQ) score
研究概览
简要总结
This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.
详细描述
This study will test a consumer health light therapy device (Re-Timer) for people with inflammatory bowel disease to better understand how it affects IBD-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.
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
- •Biopsy-proven IBD
- •Active IBD symptoms
- •Impaired IBD quality of life
- •Age >/=18 years old
- •Fluency in English
- •Physically able to travel for study visits
排除标准
- •Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome
- •Other significant chronic disease
- •Retinal pathology, history of eye surgery, taking photosensitizing medications
- •Recent history of light treatment
- •Lifetime psychotic or bipolar disorder
- •Acute suicidal ideation
- •Substance use disorder in the past 3 months, cannabis use >1/week
- •High risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy
- •Severe hearing problem, intellectual disability or serious cognitive impairment
- •Pregnant, trying to get pregnant, or breastfeeding
- •Night work or travel outside the eastern time zone in the past month
研究组 & 干预措施
Morning light treatment
A 1 hour per day morning light treatment starting at average wake time, or up to 1 hour earlier to accommodate the morning schedule. The daily treatment continues for 4 weeks.
干预措施: Morning light treatment (Device)
Treatment-as-usual
Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.
干预措施: Treatment-as-usual (Behavioral)
结局指标
主要结局
Change in Short IBD Questionnaire (SIBDQ) score
时间窗: Baseline, post-treatment approximately 36 days
SIBDQ is 10 questions, each with a Likert like scale with 7 options and lower scores indicate poorer quality of life.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b(Baseline, post-treatment approximately 36 days)
- For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)(Baseline, post-treatment approximately 36 days)
- For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)(Baseline, post-treatment approximately 36 days)
- Change in Patient Health Questionnaire 9 (PHQ-9) score(Baseline, post-treatment approximately 36 days)
研究者
Helen Burgess
Professor of Psychiatry
University of Michigan