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Clinical Trials in Turkey / NCT06875908
Recruiting Observational

Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis

NCT06875908 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istanbul Medeniyet University
Phase
Observational
Started
2025-04-15
Last updated
2025-06-17

Condition(s) studied

Multiple SclerosisSleep Disturbance

Investigational drug(s) / intervention(s)

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

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

Study summary

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 have 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Sleep disturbances — 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 — 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."

Trial sites (1)

FacilityCityRegionStatus
Bağcılar Training and Research Hospital Bağcılar Istanbul Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875908 on ClinicalTrials.gov ↗ ← All trials in Turkey