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临床试验/NCT03781076
NCT03781076已完成不适用

Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Sleep

研究概览

简要总结

The purpose of this research study is to learn more about how sleep changes as teens recover from concussions. We also want to learn if we can improve sleep in teens who have concussions.

详细描述

Mild traumatic brain injuries (mTBI), also called concussions, affect millions of individuals and cost over $17 billion in the US annually. Despite the term "mild," mTBI symptoms in children and adolescents (e.g., poor concentration, headache, emotional lability, slow thinking) seriously disrupt all aspects of a patient's functioning and impair quality of life. Although many youth recover quickly from mTBI, 30-60% remain symptomatic a month later. A biopsychosocial model was developed to account for protracted recoveries. In this model, acute symptoms result from a rapid cascade of injury-related neurometabolic and micro-structural aberrations. Since the vast majority of these abate within 1-3 weeks post-injury, persistent symptoms become increasingly difficult to explain physiologically, and psychosocial circumstances and patient behaviors become increasingly prominent contributors to impairment. There is reason to believe that, after mTBI, sleep is an underappreciated, modifiable behavior that drives impairment for youth with protracted recoveries. Care recommendations often mention sleep, but the field lacks empirically-supported guidelines and interventions for sleep after pediatric mTBI. Studies of mTBI in youth have used crude, unvalidated sleep measures. Also, there is no systematic research on non-injury contributors to poor sleep after mTBI, nor the nature and sources of advice that families receive. Lacking such data, one cannot develop empirically-based sleep recommendations. Finally, while there is reason to believe that a brief sleep intervention can alleviate mTBI symptoms in many youth who are recovering slowly, this needs to be tested in a well-powered clinical trial. The investigators are positioning to undertake such a trial, but must first document feasibility and acceptability of a sleep intervention after mTBI. To address these research gaps, the investigators are conducting a novel observational study and pilot clinical trial with these Aims:

Aim 1: Establish more detailed and definitive links between protracted mTBI recovery and sleep in 12-18-year-olds. The investigators are undertaking a prospective, observational study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team will also explore potential contributors to inadequate sleep, including sleep-related behaviors and detail the nature and sources of information on sleep post mTBI.

Aim 2: Pilot-test a brief sleep intervention in the subset of youth who are slow to recover from mTBI and show short sleep. The study team will document feasibility and acceptability, and test its success in extending sleep duration.

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 intervention explicitly involves behavior change, so the participant cannot be blinded. The outcomes assessment involves objective monitors, and therefore can be considered blind.

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

入选标准

  • 12-18 years old
  • Had a mild TBI or concussion (blow to the head associated with loss of consciousness<30 min, amnesia, or alteration in mental status) <3 weeks prior to study participation.

排除标准

  • lowest Glasgow coma scale (GCS) <13 or imaging evidence of intracranial abnormality (i.e., too severe)
  • previous more severe TBI or mTBI within the prior 3 months (potential overlapping recoveries)
  • extracranial injury with an Abbreviated Injury Severity Scale >4 for that region (non-mTBI injuries)
  • non-fluent in English
  • previously-diagnosed intellectual disability, autism, bipolar disorder, or psychosis (could impact measure validity)
  • use of medication known to substantially affect sleep (e.g., stimulant).

结局指标

主要结局

Sleep

时间窗: 1-2 weeks

Nocturnal sleep duration, quality, and regularity, as measured by wrist-mounted accelerometry (actigraphy). Although in theory there are upper limits on healthy sleep, in practice during adolescence better health is associated with longer nocturnal sleep, better sleep quality, and greater night-to-night consistency in sleep patterns.

Concussion Symptoms

时间窗: 1-2 weeks

A primary outcome for the observational phase of the study, and a secondary outcome for the intervention phase, will be the Post-Concussion Symptom Scale (PCSS). On the PCSS, 21 common symptoms after concussion are rated on a 0-6 scale; for this study the focus will be on the summed total across items. Higher scores indicate greater symptom severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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