Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06012513
Collaborator
(none)
60
27

Study Details

Study Description

Brief Summary

  1. To determine sleep disturbance in different types of multiple sclerosis.

  2. To asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis.

  3. Correlation between sleep disturbance in different types of multiple sclerosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Multiple sclerosis(MS) is a neurodegenerative disease of the central nervous system that commonly affects young adults. The disease is characterized by neurological symptoms that may lead to long-term physical disability. Patients with MS have many other problems associated with their disease, as obstructive sleep apnea (OSA) that characterized by obstructions of the respiratory tract throughout the night leadind to wake up the patients many times to achieve the right muscle tone and receive adequate oxygenation. Most patients with MS complain from poor sleep.It may be due to pain, fatigue, depression and immunotherapy that have been considered as potential factors, which could have role in sleep disturbances among MS patients.Restless leg syndrome (RLS) may trigger sleep disorders, especially insomnia, in patients with MS. Patients with sleep disorders may complain excessive daytime sleepiness, impaired concentration, altered mood, and fatigue. they are at risk to develop other problems,as vascular diseases, obesity, and diabetes, which further threaten long-term health.So patients with MS have lower quality of life(QoL) than healthy ones. Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire is the most common and standardized disease-specific questionnaire that based on the generic SF-36 QoL instrument.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Identification of different types of sleep disorders in patients with multiple sclerosis [Baseline]

      Identification of different types of sleep disorders in patients with multiple sclerosis using different scales

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. All patients fulfill the criteria of case definition of multiple sclerosis.

    2. Gender: both sexes are included.

    3. Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.

    4. Willing and able to provide informed consent.

    Exclusion Criteria:
    1. Patients unable to give informed consent.

    2. Patients with history of psychiatric disorders or collagen disease such as Behcet's disease or other neurological or medical disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohammed Safwat Mahmoud Ahmed, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06012513
    Other Study ID Numbers:
    • sleep disorders in MS
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2023