跳至主要内容
临床试验/NCT05606211
NCT05606211进行中(未招募)不适用

Pain in PASC - the Role of Sleep Disturbances

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
41
试验地点
1
主要终点
Pain sensitivity

研究概览

简要总结

Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Females and males >18 years
  • Confirmed history of SARS-CoV-2 infection
  • Exclusion Criteria
  • History of chronic pain prior to SARS-CoV-2 infection
  • Raynaud syndrome
  • Pregnant/nursing

排除标准

  • 未提供

结局指标

主要结局

Pain sensitivity

时间窗: 1 day

Pain thresholds to mechanical and temperature stimuli measured in kPa (pressure) and Celsius (heat). Lower values indicate lower pain thresholds.

Wearable based sleep characteristics

时间窗: 2 weeks

Estimation of sleep duration, fragmentation, regularity based on actigraphy

PSG based sleep characteristics

时间窗: 1 day

Sleep stages and architecture based on PSG

Central pain modulation

时间窗: 1 day

Capacity of the CNS to modulate pain

Pain reporting

时间窗: 14 days

Daily pain severity reporting on rating scale from 0 to 10 (greater values indicate greater pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monika Haack

Associate Professor of Neurology

Beth Israel Deaconess Medical Center

研究点 (1)

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