Cognitive Training on Sleeping Disorders in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170386
• Other study ID #: P.T. REC/012/003445
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Lama S Mahmoud	Al Jizah	Select State

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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