Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 40
- Primary Endpoint
- sleep disability
Study Overview
Brief Summary
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.
Detailed Description
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
opaque sealed envelope
Eligibility Criteria
- Ages
- 25 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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.
Arms & Interventions
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
Intervention: designed physical-therapy program (Other)
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
Intervention: cognitive Therapy by artificial intillegence (Other)
designed physical-therapy program
Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks)
Intervention: designed physical-therapy program (Other)
Outcomes
Primary Outcomes
sleep disability
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Rania Hamed Rashad Ahmed
principle investigator : rania hamed rashad ahmed
Cairo University
