Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis (AI)
8 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 .
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: rania hamed, master
- Número de telefone: 01112084518
- E-mail: Raniahamed542@gmail.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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sleep disability
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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cognitive disability
Prazo: up to eight weeks
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
20 de agosto de 2026
Conclusão Primária (Estimado)
30 de março de 2027
Conclusão do estudo (Estimado)
30 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
5 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Doenças autoimunes
- Doenças do sistema imunológico
- Doenças Autoimunes Desmielinizantes, SNC
- Doenças Autoimunes do Sistema Nervoso
- Doenças Desmielinizantes
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Esclerose múltipla
- Distúrbios do Sono Vigília
Outros números de identificação do estudo
- P.T.REC/012/006521
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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