Cognitive Training on Sleeping Disorders in Stroke
Effect of Cognitive Training on Sleeping Disorders in Stroke: a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Apr 2024
Shorter than P25 for not_applicable stroke
1 active site
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
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 28, 2021
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJanuary 14, 2025
January 1, 2025
6 months
December 10, 2021
January 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Epworth sleeping scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer. It is available in many different languages.
4 weeks
Pittsburgh sleep quality index ( PSQI)
0 self-reported items Minimum score: o; Maximum score: 21 0-3 scoring for each of the 7 components Higher scores indicate worse sleep quality • 7 components/sub-scales: subjective sleep qualitv, sleep latenev, sleep duration. habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction
4 weeks
Secondary Outcomes (1)
The Mini-Mental State Examination (MMSE)
four weeks
Study Arms (2)
study group
EXPERIMENTALreceive cognitive training combined with instructive conventional treatment for sleeping disorder
control group
EXPERIMENTALreceive instructive conventional treatment for sleeping disorder
Interventions
Cognitive training Therapy include: Writing the reminiscences • Solving a table• Writing a letter making a calendar and writing a note about the daily activities on it Facing patients' fears instead of avoiding them.Using role-playing to prepare for potentially problematic interactions with others.Learning to calm one's mind and relax one's body.
instructive conventional treatment breathing relaxation exercise inform of diaphragmatic breathing Practice sleep hygiene such as keeping a regular sleep schedule. Get regular exercise. Minimize noise. Minimize light. Manage the temperature so that you're comfortable.
Eligibility Criteria
You may qualify if:
- stroke onset at least 5 months prior to study enrolment
- with sleeping disturbance
- age will range from 40:55
- upper extremity spasticity ranging from
- according to Modified Ashowrth Scale.
You may not qualify if:
- difficulty to communicate
- other neurological conditions that cause sleeping disorders
- severe depression or other psychiatric symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lama S Mahmoud
Al Jīzah, Select State, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity
Study Record Dates
First Submitted
December 10, 2021
First Posted
December 28, 2021
Study Start
April 1, 2024
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
January 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share