Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Sleep Disturbances Scale for Children
研究概览
简要总结
Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge.
Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Melatonin
(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
干预措施: melatonin (Drug)
Placebo
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Sleep Disturbances Scale for Children
时间窗: 1-month
Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis.
Retention
时间窗: through study completion, an average of 30 days
Quantitative number of participants completing trial procedures per patients consented
Recruitment
时间窗: through study completion, an average of 6-months
Quantitative number of patients consented per patients approached
次要结局
- Adherence Quantitative(1-month)
- Adherence Qualitative(1-month)
- Pediatric Quality of Life Inventory Multidimensional Fatigue Scale(1-month)
- Sleep Latency(1-month)
- Total Sleep Time(1-month)
- Chronotype(1-month)
- Wake After Sleep Onset(1-month)
- Number of Night Awakenings(1-month)
- Adverse Events Time 0(hospital discharge assessed up to 7 days)
- Adverse Events Time 1(1-month)
- Sleep Efficiency(1-month)
- Sleep Onset Time(1-month)
- Sleep Offset Time(1-month)
研究者
Cydni Williams
Principal Investigator
Oregon Health and Science University