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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06875908
Enrollment
126
Registered
2025-03-13
Start date
2025-04-15
Completion date
2025-08-10
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Sleep Disturbance

Keywords

Multiple sclerosis, Sleep disturbances

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

Detailed description

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.

Interventions

OTHERTurkish 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.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep disturbancesbaselineSleep 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 qualitybaselineSleep 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEMEL METE
meteemel53@gmail.com+905376096265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026