Multiple SclerosisAINCT07762326
Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
A study testing cognitive Therapy by artificial intillegence and designed physical-therapy program in people with Multiple Sclerosis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cognitive Therapy by artificial intillegence and designed physical-therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 .
- Conditions
- Multiple Sclerosis
- Being tested
- cognitive Therapy by artificial intillegence, designed physical-therapy program
- Keywords
- Artificial Intelligence Based Cognitive Training, Sleep Disorders, Quality of Life, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive Therapy by artificial intillegenceOther
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
designed physical-therapy programOther
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
| Study group | Role | What they receive |
|---|---|---|
| cognitive Therapy by artificial intillegence | Experimental | 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 Receives: Other: cognitive Therapy by artificial intillegence; Other: designed physical-therapy program |
| designed physical-therapy program | Active comparator | Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks) Receives: Other: designed physical-therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep disability
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
Measured: up to eight weeks
daytime sleepiness
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
Measured: up to eight weeks
Secondary outcomes (5)
cognitive disability
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.
Measured: up to eight weeks
oxygen saturation
A smartwatch will be used to assess oxygen saturation.
Measured: up to eight weeks
heart rate
A smartwatch will be used to assess heart rate
Measured: up to eight weeks
life disability
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.
Measured: up to eight weeks
fatigue severity
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
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cognitive training by artificial intillegence and designed physical therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hamed Rashad Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762326
- Sponsor's protocol ID
- P.T.REC/012/006521
- Acronym
- AI
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07762326
- Acronym / sponsor ID
- AI / P.T.REC/012/006521
- Conditions
- Multiple Sclerosis
- Keywords
- Artificial Intelligence Based Cognitive Training, Sleep Disorders, Quality of Life, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cognitive training by artificial intillegence and designed physical therapy
| Arm | Type | Receives |
|---|---|---|
| cognitive Therapy by artificial intillegence | Experimental | Other: cognitive Therapy by artificial intillegence, Other: designed physical-therapy programTwenty 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 |
| designed physical-therapy program | Active comparator | Other: designed physical-therapy programTwenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive Therapy by artificial intillegenceThe 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 | cognitive Therapy by artificial intillegence |
| designed physical-therapy programPatients 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 | Other | cognitive Therapy by artificial intillegence, designed physical-therapy program |
Primary outcome
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
5 secondary outcomes
cognitive disability
Time frame: up to eight weeks
oxygen saturation
Time frame: up to eight weeks
heart rate
Time frame: up to eight weeks
life disability
Time frame: up to eight weeks
fatigue severity
Time frame: up to eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive Therapy by artificial intillegence and designed physical-therapy program in people with Multiple Sclerosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rania hamed, master (01112084518, Raniahamed542@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep disability (time frame: up to eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.