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临床试验/CTRI/2024/09/073772
CTRI/2024/09/073772尚未招募不适用

Comprehensive Assessment of Night time sleep in Conscious Guillain Barré syndrome GBS patients in Intensive Care Unit ICU. A Prospective Observational Study

National Institute of Mental Health and Neurosciences NIMHANS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To comprehensively assess the burden of sleep disturbance using EEG in GBS patients admitted to the ICU

研究概览

简要总结

Sleep is defined as a periodic, reversible state of disengagement and insensitivity from the environment. Although the sleep has a primary function of restorative process that aid in cognitive functioning, it also plays a pivotal role in metabolic conservation and produces an anabolic state. Sleep is a circadian phenomena. The most predominant factor that effect this cycle is light/dark cycle as melatonin, sleep promoting hormone is produced maximal at night. In the ICU setting disturbed sleep is multifactorial that can present with various adverse consequences, like cognitive impairment, depression, poor outcome, reduced host immunity, attenuated ventilatory response to hypoxemia and hypercapnia, increased carbon dioxide production. This in turn leads to difficulty in liberation from mechanical ventilation, and increased morbidity.  Around 30% of  GBS patients present with respiratory failure requiring ventilation and ICU admission. The mechanism of Sleep disturbance in GBS patients is attributed to involvement of lateral hypothalamus where blood-brain-barrier is exposed to antibodies, disruption in corollary discharge system, underlying stress and anxiety, proinflammatory cytokines causing neurotransmitter dysfunction, and autonomic dysfunction. Although disturbed sleep has adverse consequences, it is more recently it has taken place in ICU care and neuro-rehabilitation. There is limited data available on qualitative sleep assessment in GBS patients admitted to the ICU, we intend to conduct the study to assess the burden sleep disturbance in GBS patients, and identify the risk factors affecting the sleep during the ICU stay, and on long term sleep quality using EEG, and sleep questionnaire

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Conscious patients diagnosed with GBS admitted to ICU.

排除标准

  • Refusal of consent to participate in the study
  • Patients with hearing deficits or psychiatric illness precluding assessment
  • Patients with known sleep disorders before ICU admission.

结局指标

主要结局

To comprehensively assess the burden of sleep disturbance using EEG in GBS patients admitted to the ICU

时间窗: 1. EEG assessment will be done on day 2 of ICU admission | 2. EEG assessment will be done on day 5 of ICU admission | 3. EEG assessment will be done on day of discharge from ICU

次要结局

  • 1. To correlate the quality & quantity of sleep assessed using EEG with sleep questionnaire(2. To evaluate the effect of night tine sleep disturbance on ICU delirium, weaning from ventilator & patient satisfaction)

研究者

发起方
National Institute of Mental Health and Neurosciences NIMHANS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jhansi Eda

National Institute of Mental Health and Neurosciences

研究点 (1)

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