跳至主要内容
临床试验/NCT03150433
NCT03150433已完成不适用

Sleep and Pain in Sickle Cell Disease

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年11月5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
57
试验地点
2
主要终点
Change in Clinical pain as assessed by the Brief Pain Inventory

研究概览

简要总结

This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.

详细描述

The investigators propose to examine whether changes in sleep alter pain and pain-related outcomes in adults with Sickle Cell Disease (SCD). As many as 70% of adults with SCD experience various sleep disturbances. Pain and sleep are inter-related, such that pain disturbs sleep and disturbed sleep amplifies pain and increases risk for developing chronic pain. Pain processing occurs in the central nervous system, where nociceptive input can be inhibited or facilitated and which can undergo both functional and structural plasticity. When plasticity results in amplification of pain, this central sensitization (CS) manifests as hyperalgesia, allodynia, and spreading of pain and is an important treatment target in its own right. A growing literature implicates central sensitization in SCD, and the investigators find a strong association between laboratory-evoked CS and sleep disturbance in SCD. The neural substrates involved in pain modulation are often disrupted in chronic pain, likely due to the demands pain places on cognitive resources, and similar effects are seen with chronic insomnia. It remains unclear whether these changes occur in SCD and if improving sleep improves central modulation of pain. The potential for improved sleep to reduce pain and CS requires additional investigation, particularly given the significance of sleep disturbance as a mutable risk factor. The investigators will conduct a randomized trial in which it will be determined whether improvements in sleep reduce pain and alter brain processing of pain and cognitive stimuli. The aims are to determine whether treatment of sleep improves pain outcomes in SCD and to determine whether treatment of sleep alters functional connectivity of cognitive and pain modulatory networks using brain imaging in SCD.

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

Outcome assessors will be masked to treatment condition

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of sickle cell hemoglobinopathy (Homozygous sickle cell disease, Hemoglobin SC disease, or Sickle/beta-thalassemia);
  • Adequate facility with English;
  • Stable dosing of medications (if taking) for pain and sleep;
  • Reports symptoms of insomnia;
  • Reports chronic pain

排除标准

  • Cognitive impairment;
  • Unstable psychiatric disorder;
  • Seizure disorder;
  • Positive pregnancy or drug test

结局指标

主要结局

Change in Clinical pain as assessed by the Brief Pain Inventory

时间窗: baseline and 24 weeks

Average of 4 items from the Brief Pain Inventory; each rated on a 0 (no pain) to 10 (pain as bad as you can imagine); ratings are made of pain right now, typical pain, worst pain, and least pain during the past week. Total sub-score of 0-40 with higher score indicating more pain.

次要结局

  • Change in Central Sensitization Index(baseline and 12 weeks)
  • Change in functional connectivity/cognitive task(baseline and 12 weeks)
  • Change in Clinical pain as assessed by the Brief Pain Inventory(baseline and 36 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Sleep and Pain in Sickle Cell Disease | 临床试验