Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Immunological study: cytokines.
研究概览
简要总结
Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.
The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response.
详细描述
Sleep and immune system have reciprocal relationship. Sleep has a restorative role on immune system, influencing innate and adaptive immunity and sleep disorders can decrease immune response.
Healthy innate immunity is crucial into regulation of the response against SARS-CoV-2.
The hypothesis of the study is that the innate immunity response is blunted by sleep disorders and, this mitigated immune response, could influence on COVID-19 severity. Impaired immune response in patients with sleep disorders could be ameliorated inducing trained immunity by influenza vaccine.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.
排除标准
- •>70 years and <18 years
- •Recent COVID-19 (<6 months)
- •Other infection (<3 months)
- •Obstructive sleep apnea in treatment with CPAP prior to COVID infection.
- •Immunosuppressed
结局指标
主要结局
Immunological study: cytokines.
时间窗: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
To measure in blood: IL-1 beta, IL-6, IL-8, IL-10, TNF-alfa, IFN-alfa, IFN-gamma, GM-CSF.
次要结局
- Epigenetic modification.(To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.)
- Innate cells: monocytes, classical dendritic cells and Natural Killer cells.(To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.)
- Diagnostic of obstructive sleep apnea in selected cohort(It is an overnight study that will last for one night.)
研究者
Andrea Grau Freixinet
Pulmonology medical specialist
Parc Taulí Hospital Universitari