Sleep and Pain in Childhood Arthritis: A Crossover Randomized Trial Comparing Adequate and Restricted Sleep Duration, and Its Impact on Pain in Adolescents With Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Pain as measured on the PROMIS Pain Interference Scale
研究概览
简要总结
Childhood arthritis is an important cause of pain for affected children and youth (adolescents). Many youth with arthritis also have trouble sleeping. They often struggle to sleep through the night, wake up earlier, and are sleepier during the day compared to healthy children. Our research group, among others, has shown a strong link between sleep and pain. The main purpose of this study is to assess the impact of changing sleeping patterns on pain, and disease activity, in teenagers with arthritis. We think that better sleep will directly lead to better health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient in the rheumatology clinic at SickKids
- •all subtypes of JIA, as per the ILAR criteria
- •a baseline pain score of ≥ 1 on a visual analogue scale
- •age from 12-18 years old
- •capable of providing informed consent form themselves, as judged by the clinical team
排除标准
- •a known sleep disorder (e.g., obstructive sleep apnea, etc.)
- •a high probability of having obstructive sleep apnea as determined by the Pediatric Sleep Questionnaire
- •currently taking medication with the intent to impact sleep (e.g., zolpidem, benzodiazepines, etc.)
- •taking corticosteroids (which may adversely affect sleep)
- •obligations that require a bed time later than 10:00 pm or a wake time earlier than 5:30 am during the study period
- •daily consumption of > 1 coffee or "energy drink" and/or > 3 caffeinated carbonated beverages
- •do not speak/understand English with enough proficiency to complete all study related tasks, as judged by the clinical team
结局指标
主要结局
Change in Pain as measured on the PROMIS Pain Interference Scale
时间窗: baseline, end of baseline week, end of experimental week 1, end of experimental week 2
Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale. Scores can range from 0-100 with 100 representing the best possible outcome
次要结局
- Change in Pain as measured on the PROMIS Pain Behaviour Scale(baseline, end of baseline week, end of experimental week 1, end of experimental week 2)
- Change in Inattention and Sleepiness(baseline, end of baseline week, end of experimental week 1, end of experimental week 2)
- Pain as measured using the iCanCope with Pain app(end of study (3 weeks))
- Change in Disease Activity(baseline, end of baseline week, end of experimental week 1, end of experimental week 2)
- Change in Health Related Quality of Life(baseline, end of baseline week, end of experimental week 1, end of experimental week 2)
- Physical Activity(end of study (3 weeks))
- Change in Functional Status(baseline, end of baseline week, end of experimental week 1, end of experimental week 2)
研究者
Brian Feldman
Division Head, Division of Rheumatology
The Hospital for Sick Children