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Cognitive Training on Sleeping Disorders in Stroke

Primary Purpose

Stroke, Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cognitive training Therapy
instructive conventional treatment
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, sleep disorders, cognition

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lama S MahmoudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

receive cognitive training combined with instructive conventional treatment for sleeping disorder

receive instructive conventional treatment for sleeping disorder

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2021
Last Updated
January 1, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05170386
Brief Title
Cognitive Training on Sleeping Disorders in Stroke
Official Title
Effect of Cognitive Training on Sleeping Disorders in Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sleep Disorder
Keywords
Stroke, sleep disorders, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A (20 patients): that will receive cognitive training combined with instructive conventional treatment for sleeping disorder, and group B (20 patients): that will receive instructive conventional treatment for sleeping disorder
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
receive cognitive training combined with instructive conventional treatment for sleeping disorder
Arm Title
control group
Arm Type
Experimental
Arm Description
receive instructive conventional treatment for sleeping disorder
Intervention Type
Other
Intervention Name(s)
Cognitive training Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
instructive conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epworth sleeping scale (ESS)
Description
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.
Time Frame
4 weeks
Title
Pittsburgh sleep quality index ( PSQI)
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Mini-Mental State Examination (MMSE)
Description
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
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lama Saad ED Mahmoud
Phone
01157592636
Email
lamaelsedawyy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Magdy Alshimy, PHD
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud
Phone
01157592636
Email
lamaelsedawyy@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Training on Sleeping Disorders in Stroke

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