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

August 8, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: cognitive Therapy by artificial intillegence
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
Other: 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
Active Comparator: designed physical-therapy program
Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to eight weeks
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
up to eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive disability
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.
up to eight weeks
oxygen saturation
Time Frame: up to eight weeks
A smartwatch will be used to assess oxygen saturation.
up to eight weeks
heart rate
Time Frame: up to eight weeks
A smartwatch will be used to assess heart rate
up to eight weeks
life disability
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.
up to eight weeks
fatigue severity
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
up to eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 8, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 8, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/006521

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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