Effect of Artificial Intelligence Based Cognitive Training on Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis (AI)
8. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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 .
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: rania hamed, master
- Telefonnummer: 01112084518
- E-Mail: Raniahamed542@gmail.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
|
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
|
|
Aktiver Komparator: designed physical-therapy program
Twenty patients with multiple sclerosis will receive a designed physical-therapy program 3 times per week for 8 weeks)
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
sleep disability
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
cognitive disability
Zeitfenster: 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
Zeitfenster: up to eight weeks
|
A smartwatch will be used to assess oxygen saturation.
|
up to eight weeks
|
|
heart rate
Zeitfenster: up to eight weeks
|
A smartwatch will be used to assess heart rate
|
up to eight weeks
|
|
life disability
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
20. August 2026
Primärer Abschluss (Geschätzt)
30. März 2027
Studienabschluss (Geschätzt)
30. März 2027
Studienanmeldedaten
Zuerst eingereicht
5. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. August 2026
Zuerst gepostet (Tatsächlich)
13. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Autoimmunerkrankungen
- Erkrankungen des Immunsystems
- Demyelinisierende Autoimmunerkrankungen, ZNS
- Autoimmunerkrankungen des Nervensystems
- Demyelinisierende Krankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Multiple Sklerose
- Schlaf-Wach-Störungen
Andere Studien-ID-Nummern
- P.T.REC/012/006521
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .