NCT07762326

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable multiple-sclerosis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 5, 2026

Last Update Submit

August 8, 2026

Conditions

Keywords

Artificial Intelligence Based Cognitive TrainingSleep DisordersQuality of LifeMultiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    up to eight weeks

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

Other: cognitive Therapy by artificial intillegenceOther: 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)

Other: designed physical-therapy program

Interventions

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

cognitive Therapy by artificial intillegence

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

cognitive Therapy by artificial intillegencedesigned physical-therapy program

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisSleep Wake Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

rania hamed, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cognitive training by artificial intillegence and designed physical therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : rania hamed rashad ahmed

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 13, 2026

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08