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

NCT06875908 | Recruiting

• 1 other identifier: MS-GSDS
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis; Sleep Disturbance

Keywords

Multiple sclerosis; Sleep disturbances

Outcome Measures

Primary Outcomes (2)

• Sleep disturbances

  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.

  baseline

• Sleep quality

  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."

  baseline

Study Arms (1)

Patients with MS

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.

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

Interventions

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.

Patients with MS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple sclerosis who are aged 18-65 years with EDSS score \> 2 and able to speak and read Turkish.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Bağcılar Training and Research Hospital

Bağcılar, Istanbul, 34200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Parasomnias

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

EMEL METE

CONTACT

+905376096265; meteemel53@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: April 15, 2025
• Primary Completion: July 20, 2025
• Study Completion: August 10, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)