NCT Number: NCT07762326
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.
Trial opening soon.
Get Notified25 year–40 year
All sexes
Interventional
Not applicable
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 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.
Time frame: up to eight weeks
A smartwatch will be used to assess oxygen saturation.
Time frame: up to eight weeks
A smartwatch will be used to assess heart rate
Time frame: up to eight weeks
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.
Time frame: up to eight weeks
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
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Acronym: AI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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