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Recruiting NCT06875908

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

Observational Multiple Sclerosis Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Sleep Disturbance. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other 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 reliabi

Primary outcome measures

  • Sleep disturbances [Time frame: baseline]
  • Sleep quality [Time frame: baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Bağcılar Training and Research Hospital — Bağcılar

Identifiers

NCT: NCT06875908 · MS-GSDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗