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Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT06012513
Recruitment Status : Not yet recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Mohammed Safwat Mahmoud Ahmed, Assiut University

Study Description
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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
Sleep Disorder

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Identification of different types of sleep disorders in patients with multiple sclerosis [ Time Frame: Baseline ]
    Identification of different types of sleep disorders in patients with multiple sclerosis using different scales


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Multiple Sclerosis according to McDonald Criteria 2017 attending the neurology outpatient clinic, Department of Neurology and Psychiatry,Assiut University
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012513


Contacts
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Contact: Mohammed Safwat Mahmoud Ahmed, Resident doctor 01270577899 mhmdsfwt746@gmail.com
Contact: Tareq Ali Sayed Rageh, professor 01010077712 tarek-rageh@hotmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Mohammed Safwat Mahmoud Ahmed, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT06012513    
Other Study ID Numbers: sleep disorders in MS
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sleep Wake Disorders
Parasomnias
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Mental Disorders