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临床试验/CTRI/2025/11/097665
CTRI/2025/11/097665尚未招募不适用

Prevalence and patterns of sleep disturbances in neurocritical care patients assessed by Polysomnography-: A pilot observational study

NIMHANS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12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
NIMHANS
入组人数
20
试验地点
1

研究概览

简要总结

This is a prospective observational study including patients admitted to Neuro-ICUs diagnosed with GBS and Myasthenia gravis and are conscious. This study will be conducted over 6 months after Institutional Ethics Board approval.                                                                                                                                                                                                                           All GBS and Myasthenia gravis patients admitted to Neuro-ICUs will be screened with inclusion and exclusion criteria. Patients will receive standard care provided by the ICU physician in charge. APACHE II score at the time of ICU admission, pre-existing sleep disturbances over a preceding 1-month period will be assessed using self-rated questionnaire of Pittsburgh Sleep Quality Index (PSQI) which will be answered by the next of kin. After taking the informed consent, patient will be briefed about the Richard Campbell Sleep Questionnaire. It is a 5 item self-report questionnaire. It has a Visual Analog Scale (VAS) ranging from 0 – 100 mm, with higher scores representing better sleep. The data is collected from the patient in the afternoon and total score, which is the mean of all 5 variables will be taken to assess the perception of sleep. The same day we do the comprehensive sleep analysis with Polysomnography.

Polysomnography includes recording of Electroencephalogram (EEG), Electrooculogram (EOG), Electromyogram (EMG), Electrocardiogram (ECG), Respiratory efforts, Pulse oximetry, Snoring sounds.

For EEG recording, EEG cup electrodes will be attached to the scalp with the help of adhesive glue and secured with a roller gauze wrapped around the head. Sleep EEG recording is done according to the American Academy of Sleep Medicine (AASM) criteria. The AASM recommends the following derivation- F4-M1, C4-M1, and O2-M1, F3-M2, C3-M2, and O1-M2.

1st polysomnography study: on day 2 of ICU admission for 16-24 hours

2nd polysomnography study:  at 5-7 days of ICU admission for 16-24 hours

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted to ICU with Guillain Barre Syndrome or Myasthenia Gravis who are conscious and oriented.

排除标准

  • Patients who are sedated and ventilated.
  • Patients with a known history of hearing deficits, seizure disorder, intellectual disability, and psychiatric illness.

研究者

发起方
NIMHANS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Jithu Mohan P

NIMHANS

研究点 (1)

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