Reliability and Validity of the Turkish… | Clinical Trial

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bağcılar Training and Research Hospital

Bağcılar, Istanbul, 34200, Turkey (Türkiye)

Location status: Recruiting

About this study

The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale has been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. GSD has 21 questions. This study will be conducted on patients with multiple sclerosis (MS). 126 participants will be included in the study. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals over the age of 18 who have been diagnosed with Multiple Sclerosis for at least two years,
Those with an EDSS score >2.
Those without symptoms of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria
Individuals whose native language is Turkish and who have the ability to speak and understand.

Exclusion criteria

Those with severe spasticity,
Those with vision and hearing problems,
Those with a known mental illness (major depression, schizophrenia, psychosis, etc.),
Those in an acute relapse phase,
Those using dietary supplements,
Those using tranquilizers or immunosuppressants.

Treatment and study plan

Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis

Other

The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. It has 21 questions. This study will be conducted on patients with multiple sclerosis. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Primary outcomes

Sleep disturbances

Time frame: baseline

Sleep disturbances will be assessed with the general sleep disturbance scale (GSDS). It consists of 21 items in total. Each item is scored on a scale of 0-7 includes six sub-categories: Difficulty falling asleep, waking up from sleep; sleep quality; sleep duration; daytime sleepiness; and taking supplements to help sleep. The total score is the calculated sum of 21 items. The minimum score is "0" while the maximum score is "147" points. Higher scores indicate more sleep disturbances.
Sleep quality

Time frame: baseline

Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 24 questions in total. The scale has 7 components: sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6), and daytime sleep dysfunction (component 7). Each component is evaluated on a 0-3 scale. The sum of these 7 component scores gives the total PSQI score. The total PSQI score varies between 0-21. While the sleep quality of individuals with a total score of 5 and below is evaluated as "good," the sleep quality of individuals with a score above 5 is evaluated as "poor."

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 13, 2025
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed