Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Sleep Disorder Clinical Trial

Official title:

Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012513
• Other study ID #: sleep disorders in MS
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Mohammed Safwat Mahmoud Ahmed, Resident doctor
• Phone: 01270577899
• Email: mhmdsfwt746[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of different types of sleep disorders in patients with multiple sclerosis	Identification of different types of sleep disorders in patients with multiple sclerosis using different scales	Baseline