Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

NCT ID: NCT06012513

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Sleep Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Safwat Mahmoud Ahmed

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed Safwat Mahmoud Ahmed, Resident doctor

Role: CONTACT

mhmdsfwt746@gmail.com

01270577899

Tareq Ali Sayed Rageh, professor

Role: CONTACT

tarek-rageh@hotmail.com

01010077712

References

Tachibana N, Howard RS, Hirsch NP, Miller DH, Moseley IF, Fish D. Sleep problems in multiple sclerosis. Eur Neurol. 1994;34(6):320-3. doi: 10.1159/000117070.

Reference Type: BACKGROUND

PMID: 7851452 (View on PubMed)

Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.

Reference Type: BACKGROUND

PMID: 18207453 (View on PubMed)

Other Identifiers

sleep disorders in MS

Identifier Type: -

Identifier Source: org_study_id