Clinical trial NCT06012513: Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
Official title: Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Identification of different types of sleep disorders in patients with multiple sclerosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.