Assessing sleep disturbances in Turkish patients with multiple sclerosis
Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
This study is testing a new Turkish sleep questionnaire to see how well it works for people with multiple sclerosis who have sleep problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istanbul Medeniyet University Academic / other |
| Locations | 1 site (Bağcılar, Istanbul) |
| Trial ID | NCT06875908 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the validity and reliability of the Turkish version of the General Sleep Disturbance Scale (GSDS-T) specifically for patients diagnosed with multiple sclerosis (MS). It will involve 126 participants who have been living with MS for at least two years and will assess various aspects of sleep quality and disturbances. The study will utilize the Pittsburgh Sleep Quality Index (PSQI) as a benchmark for evaluating the GSDS-T, with scales being repeated after 15 days to measure test-retest reliability. The findings could provide valuable insights into sleep issues faced by MS patients in Turkey.
Who should consider this trial
Good fit: Ideal candidates are Turkish-speaking individuals over 18 years old diagnosed with multiple sclerosis for at least two years and with an EDSS score greater than 2.
Not a fit: Patients with severe spasticity, vision or hearing problems, known mental illnesses, or those in an acute relapse phase may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment tools for sleep disturbances in multiple sclerosis patients, enhancing their overall care.
How similar studies have performed: While the GSDS-T has been validated in stroke patients, this is a novel approach as it focuses on multiple sclerosis patients, indicating a gap in existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bağcılar, Istanbul
- Bağcılar Training and Research Hospital — Bağcılar, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Emel Mete
- Email: meteemel53@gmail.com
- Phone: +905376096265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.