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临床试验/NCT07762326
NCT07762326尚未招募不适用

Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Cairo University0 个研究点目标入组 40 人开始时间: 2026年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
sleep disability

研究概览

简要总结

this study will be conducted to investigate the effect of artificial intelligence (AI) based cognitive training on sleep disorders and quality of life in patients with multiple sclerosis.

详细描述

Multiple sclerosis (MS) is a chronic progressive inflammatory autoimmune neurodegenerative disease of central nervous system (CNS) and it is considered to be the most prevalent neurological disability of young adults, often leads to severe physical or cognitive incapacitation. The severity of disability in MS patients is increased not only by motor disorders and other neurological deficit, but by the presence of cognitive impairment (CI), psycho-emotional disorders, like anxiety and/or depression, and sleep disorders (SD). Cognitive dysfunction is one of the most common and consequential symptoms of MS. Impairments in processing speed, working memory, learning, executive function, visuospatial processing, and language function affect an estimated 42% to70% of individuals with MS, and constitute a major cause of loss of employment and reduced quality of life. Despite its high prevalence and effect, there are no definitive treatments for cognitive dysfunction in MS, and the identification of appropriate strategies to improve cognition in MS is hindered by a poor understanding of modifiable factors that may influence its severity. AI is playing a significant role in harnessing neuroplasticity for cognitive enhancement through innovative applications such as cognitive training programs.These programs, driven by machine learning algorithms, can adapt to individual user performance, providing personalized training that optimizes cognitive functions such as memory, attention, and problem-solving .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

opaque sealed envelope

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient's age ranges from 25-40 years.
  • •Patient with EDSS not more than
  • •Patients who have no relapses for the previous three months.
  • •Patients with sufficient cognitive abilities that enables them to understand and follow
  • •instructions with a score more than 24 according to the Mini-Mental State Examination scale

排除标准

  • •Mechanical or neuromascular problems.
  • •Cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
  • •Auditory problems.
  • •Sensory impairment caused by other diseases except the MS such as diabetes mellitus.

研究组 & 干预措施

cognitive Therapy by artificial intillegence

Experimental

Twenty patients with multiple sclerosis will receive a cognitive therapy by Lumosity application in addition to a designed physical-therapy program 3 times per week for 8 weeks

干预措施: designed physical-therapy program (Other)

cognitive Therapy by artificial intillegence

Experimental

Twenty patients with multiple sclerosis will receive a cognitive therapy by Lumosity application in addition to a designed physical-therapy program 3 times per week for 8 weeks

干预措施: cognitive Therapy by artificial intillegence (Other)

designed physical-therapy program

Active Comparator

Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks)

干预措施: designed physical-therapy program (Other)

结局指标

主要结局

sleep disability

时间窗: up to eight weeks

Pittsburgh Sleep Quality Index will be used to assess sleep disability. it gives impression on sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over one month, The sum of scores for these seven components yields one global score. Scoring of the answers is based on a 0 to 3 scale and a global sum equal or larger than 5 indicates a "poor" sleeper

daytime sleepiness

时间窗: up to eight weeks

Epworth Sleepiness Scale will be used to assess daytime sleepiness. It measures the general level of daytime sleepiness it is composed of 8 items to rate on a 4 -point scale (0-3). A higher score indicates higher level of daytime sleepiness. Using a cut-off score \> 10, it is possible to identify individuals with excessive daytime sleepiness. Scores \>16 indicates ever sleepiness

次要结局

  • cognitive disability(up to eight weeks)
  • oxygen saturation(up to eight weeks)
  • heart rate(up to eight weeks)
  • life disability(up to eight weeks)
  • fatigue severity(up to eight weeks)

研究者

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

Rania Hamed Rashad Ahmed

principle investigator : rania hamed rashad ahmed

Cairo University

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