Cognitive Training on Sleeping Disorders in Stroke

Effect of Cognitive Training on Sleeping Disorders in Stroke: a Randomized Controlled Trial

Cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.

Study Overview

• Status: Completed
• Conditions: Stroke; Sleep Disorder
• Intervention / Treatment: Other: Cognitive training Therapy; Other: instructive conventional treatment

Detailed Description

40 patients from both sexes will participate in this study. All the patients have to be diagnosed as stroke patients. The patients will be divided into two groups; group A (20 patients): which will receive cognitive training combined with instructive conventional treatment for a sleeping disorder, and group B (20 patients): which will receive instructive conventional treatment for sleeping disorder all the patients will be assessed pre and post-treatment using 1- Epworth sleeping scale, 2-Pittsburgh sleep quality index ( PSQI) 3- MINI mental cognitive scale

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Select State
    • Al Jīzah, Select State, Egypt
      • Lama S Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• difficulty to communicate
• other neurological conditions that cause sleeping disorders
• severe depression or other psychiatric symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; receive cognitive training combined with instructive conventional treatment for sleeping disorder	Other: Cognitive training Therapy; 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.; Other: instructive conventional treatment; 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.
Experimental: control group; receive instructive conventional treatment for sleeping disorder	Other: instructive conventional treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mini-Mental State Examination (MMSE)	The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairmen Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment	four weeks

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; cognition; sleep disorders
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Stroke; Parasomnias; Sleep Wake Disorders
• Other Study ID Numbers: P.T. REC/012/003445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No