At Home Morning Bright Light Treatment for Chronic Nociplastic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
研究概览
简要总结
This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.
详细描述
This study will test a consumer health light therapy device (Re-Timer)
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
- Single (Outcomes Assessor)
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
- •Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
- •Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.
排除标准
- •Significant chronic disease
- •Severe hearing or memory problems
- •Pending medical leave applications at workplace
- •Current pregnancy, breastfeeding, or actively trying to get pregnant
- •Night work or travel outside the eastern time zone within 1 month of the study
- •Other research participation
- •Frequent number of special events during study period (weddings, concerts, exams, etc).
研究组 & 干预措施
Control Group, treatment as usual
Participants will be asked to sleep as per usual.
Light Therapy
All participants will be asked to attend 8 virtual visits over 5 months.
Participants randomized to the morning light therapy group are asked to wear the glasses for 1 hour per day. The timing of each person's therapy is tailored to their average wake up time during a baseline period. The treatment period is 4 weeks long.
干预措施: Light Therapy (Device)
Sleep Stabilization
All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the sleep stabilization arm are asked to follow a fixed sleep schedule tailored to their sleep during a baseline period. The treatment period is 4 weeks.
干预措施: Sleep Stabilization (Behavioral)
结局指标
主要结局
Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
时间窗: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
The FIQR is 21 questions. Each question has 11 boxes similar to a visual analog scale. Questions include the difficulty associated with various physical activities and the severity of symptoms. The score for the questions is on a scale from 0 - 100, where lower scores represented better functional status.
次要结局
- Change in Brief Pain Inventory (BPI) score(baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).)
研究者
Helen Burgess
Professor of Psychiatry, Medical School
University of Michigan