Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis (AI)
2026年8月8日 更新者：Rania Hamed Rashad Ahmed、Cairo University
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.
研究概览
地位
尚未招聘
条件
详细说明
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 .
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：rania hamed, master
- 电话号码：01112084518
- 邮箱：Raniahamed542@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Patient's age ranges from 25-40 years.
- Patient with EDSS not more than 5.
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：cognitive Therapy by artificial intillegence
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
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The patients will receive cognitive therapy by an artificial intelligence application called Lumosity.
Lumosity is an online cognitive training that can incredibly engage the individual's innate neuroplasticity, making the person smarter.
Perhaps Lumosity training actually increases the release of dopamine, the neurochemical that is very crucial for many brain functions, and the puls-designed physical therapy program
Patients will receive designed physical-therapy program in the form of sleep and bedtime restrictions, stimulus control instructions, education for sleep and promoting good sleep habits (or sleep hygiene), teaching relaxation skills
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有源比较器：designed physical-therapy program
Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks)
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Patients will receive designed physical-therapy program in the form of sleep and bedtime restrictions, stimulus control instructions, education for sleep and promoting good sleep habits (or sleep hygiene), teaching relaxation skills
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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sleep disability
大体时间：up to eight weeks
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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
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up to eight weeks
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daytime sleepiness
大体时间：up to eight weeks
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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
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up to eight weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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cognitive disability
大体时间：up to eight weeks
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CogniFit will be used to assess cognitive function.
it is a digital health platform offering computerized cognitive assessments and interventions for users, researchers, and practitioners.
The CogniFit cognitive score is an aggregate measure of your brain's performance across 20 more different cognitive skills.
The scale ranges from a minimum of 0 to a maximum of 800, evaluated against normalized data matched to your specific age and gender.
0 - 200 (Red): Below average for your age and sex; highlights a cognitive weakness.
200 - 400 (Yellow): Low range, but still within the normal average and open to improvement.
400-600 (Green): High score within the average; indicates good condition relative to peers.600-800
(Green): Above average; signals a distinct cognitive strength or skil.
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up to eight weeks
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oxygen saturation
大体时间：up to eight weeks
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A smartwatch will be used to assess oxygen saturation.
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up to eight weeks
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heart rate
大体时间：up to eight weeks
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A smartwatch will be used to assess heart rate
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up to eight weeks
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life disability
大体时间：up to eight weeks
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World Health Organization Quality of Life Assessment Brief will be used to assess life disability.
it has a four-domain structure which are physical health, psychological domain, social domain and environmental domain to provide a short-form quality of life assessment.
Subjects rated all items on a 5-point Likert-type scale.
Raw scores for the domains of WHOQOL-BREF were calculated by adding values of single items and were transformed on the scale ranging from 0 to 100 where 100 is the highest and 0 the lowest.
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up to eight weeks
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fatigue severity
大体时间：up to eight weeks
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The fatigue severity scale FSS will be used to assess fatigue severity.
it is a self-report scale with nine items that assess the degree of physical fatigue over the previous week.
The Fatigue Severity Scale (FSS) is scored by adding the answers to 9 questions and finding the total sum or the average mean.
Each question uses a 7-point scale from 1 (strongly disagree) to 7 (strongly agree) based on the past week.
Add all 9 numbers together.
The total score ranges from 9 to 63.Divide the total sum by 9.
The average score ranges from 1.0 to 7.0.a
higher score indicates more severity
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up to eight weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月20日
初级完成 (估计的)
2027年3月30日
研究完成 (估计的)
2027年3月30日
研究注册日期
首次提交
2026年8月5日
首先提交符合 QC 标准的
2026年8月8日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月8日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- P.T.REC/012/006521
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