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临床试验/NCT03446066
NCT03446066已完成不适用

Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

Kasr El Aini Hospital0 个研究点目标入组 40 人开始时间: 2015年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
change in Quantitative electroencephalography (QEEG) and P300 results from before to after single night sleep record in patients with excessive daytime sleepiness (EDS)

研究概览

简要总结

Cognition was assessed using Minimental state examination (MMSE), Trail making tests A and B (TMT) tests, P300 and quantitative electroencephalography (QEEG) sleepiness was assessed using Epworth Sleepiness Scale (ESS), Karolinska sleepiness scale (KSS) and QEEG also polysomnography (PSG) was done for all participated subjects

详细描述

*The study is a case control study included 40 subjects, divided into 20 cases suffering from Excessive daytime sleepiness and 20 healthy control group.

all participants were subjected to:

  1. Careful history taking and Complete neurological examination.
  2. Initial assessment of cognition and sleepiness by two scales which were done once before sleep: Epworth Sleepiness Scale (ESS) and Minimental state examination (MMSE)
  3. Scales and neurophysiological studies done before and after sleep:Karolinska sleepiness scale (KSS), Trail making tests A and B (TMT), P300, and QEEG
  4. Polysomnography (PSG)
  • EEG was recorded for 20 minutes duration before and after sleep recording. In each EEG recording, alpha attenuation test (AAT) was done after 10 minutes of recording basal resting EEG, then the absolute power of 5 electrodes (CZ, T3, T4, T5, T6,) were studied in the following frequency bands: delta (0.5-3Hz), theta (4-7 Hz) and also the absolute power of (O1, O2) were studied in delta, theta and alpha (8-12 Hz) bands.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
31 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The age ranges from 18 to 60 years. The age of all included subjects was 31-58 yrs old.
  • The body mass index (BMI) range is 24.97-39.06 kg/m2 in patients and 23.40-43.0 kg/m2 in control group.
  • Patients suffering from excessive daytime sleepiness symptoms according to the International Classification of Sleep Disorders definitions.

排除标准

  • Patients suffering from EDS secondary to any sleep disorder other than sleep disordered breathing.
  • Chronic debilitating disease as diabetes mellitus , hypertension or hyper- or hypo-thyroidism.
  • Medications that could affect attention or vigilance as Benzodizipines, anti-psychotics or anti-epileptics.

结局指标

主要结局

change in Quantitative electroencephalography (QEEG) and P300 results from before to after single night sleep record in patients with excessive daytime sleepiness (EDS)

时间窗: 1 year

the results of QEEG and P300 in patients with EDS before and after sleep

次要结局

  • potential integration of quantitative EEG and P300 as diagnostic tools for cognition and EDS.(1year)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leqaa El Mekkawy

assistant lecturer

Kasr El Aini Hospital

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