Multiple SclerosisNCT06875908
Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
An observational study of Multiple Sclerosis and Sleep Disturbance, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Sleep Disturbance
- What is being tested?
- Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 10 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Multiple sclerosis who are aged 18-65 years with EDSS score > 2 and able to speak and read Turkish.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bağcılar Training and Research Hospital
Bağcılar, Istanbul, 34200
EMEL METE, +905376096265, meteemel53@gmail.com
Veysel Akduman, PhD
About this study
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
Read the 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.
- Conditions
- Multiple Sclerosis, Sleep Disturbance
- Being tested
- Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis
- Keywords
- Multiple sclerosis, Sleep disturbances
- Medical subject headings
- Multiple Sclerosis, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosisOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Apr 2025
- Primary completion20 Jul 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875908
- Sponsor's protocol ID
- MS-GSDS
- Status last verified
- May 2025
- First submitted
- 9 Mar 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06875908
- Acronym / sponsor ID
- MS-GSDS
- Conditions
- Multiple Sclerosis, Sleep Disturbance
- Keywords
- Multiple sclerosis, Sleep disturbances
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MS | – | Other: Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosisTurkish 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple sclerosis who are aged 18-65 years with EDSS score > 2 and able to speak and read Turkish.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosisThe 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 | Patients with MS |
Primary outcome
Sleep disturbances
Time frame: 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
Time frame: 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."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Sleep Disturbance, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMEL METE (+905376096265, meteemel53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbances (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.