Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

August 24, 2023 updated by: Mohammed Safwat Mahmoud Ahmed, Assiut University
  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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohammed Safwat Mahmoud Ahmed, Resident doctor
  • Phone Number: 01270577899
  • Email: mhmdsfwt746@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sleep disorders in MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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