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Completed

NCT Number: NCT05170386

Cognitive Training on Sleeping Disorders in Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Vascular Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lama S Mahmoud

Al Jīzah, Select State, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive training Therapy

Other

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

Other

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 outcomes

  1. Epworth sleeping scale (ESS)

    Time frame: 4 weeks

    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.

  2. Pittsburgh sleep quality index ( PSQI)

    Time frame: 4 weeks

    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 outcomes

  1. The Mini-Mental State Examination (MMSE)

    Time frame: four weeks

    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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2021
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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