Multiple SclerosisNCT07536503
Effects of Sleep Quality on Functional and Cognitive Outcomes in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Büşra Seçkinoğulları Korkusuz at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the effects of sleep quality on cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals aged 18-65 years who have been diagnosed with Multiple Sclerosis and are receiving routine care at the Department of Physical Therapy and Rehabilitation of Başkent University Hospital. Participants who meet the inclusion criteria and voluntarily agree to participate will be enrolled in the study.
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of Multiple Sclerosis
- Montreal Cognitive Assessment (MoCA) score ≥24
- Expanded Disability Status Scale (EDSS) score between 0 and 6.5
- No relapse within the last 3 months
- Voluntary participation with written informed consent
Who cannot join
- Presence of other neurological, psychiatric, or systemic diseases
- Severe visual, auditory, or balance impairments
- History of surgery within the last 6 months
- Use of sleep medication or central nervous system-affecting drugs
- Severe orthopedic deformity or pain
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
Baskent University Ankara Hospital
Ankara, Ankara, 06810
Süleyman Korkusuz, PhD, +905388675480, suleyman.korkusuz@atilim.edu.tr
About this study
Official title: Effects of Sleep Quality on Cognitive Flexibility, Physical Activity, Body Awareness, and Reaction Time in Multiple Sclerosis
The goal of this observational study is to investigate the effects of sleep quality on cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis.
The main question it aims to answer is:
Read more
Does sleep quality influence cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis?
Researchers will compare individuals with good and poor sleep quality to determine whether differences in sleep quality result in variations in cognitive and physical performance outcomes.
Participants will complete standardized assessments of sleep quality, cognitive flexibility, physical activity, and body awareness, and will perform a computer-based reaction time test. In addition, participants will wear a wearable activity tracker for 7 days to objectively measure physical activity levels.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Sleep Quality, Cognitive Flexibility, Physical Activity, Reaction Time, Body Awareness
- Medical subject headings
- Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Good Sleep Quality Group | Participants with Multiple Sclerosis who have a Pittsburgh Sleep Quality Index (PSQI) score of 5 or below, indicating good sleep quality. | |
| Poor Sleep Quality Group | Participants with Multiple Sclerosis who have a Pittsburgh Sleep Quality Index (PSQI) score above 5, indicating poor sleep quality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline
Cognitive Flexibility (Stroop Test, TBAG Form)
Cognitive flexibility will be evaluated using the Stroop Test TBAG Form. Test completion time and number of errors will be recorded; longer completion times and more errors indicate lower cognitive flexibility.
Measured: Baseline
Physical Activity Level (International Physical Activity Questionnaire-Short Form)
Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form. Total physical activity will be calculated in MET-min/week.
Measured: Baseline
Physical Activity Level (Wearable Device)
Daily step count will be recorded using a wearable activity tracker. Average step count over 7 days will be calculated.
Measured: 7 days
Body Awareness Questionnaire
Body awareness will be evaluated using the Body Awareness Questionnaire. Higher scores indicate greater body awareness.
Measured: Baseline
Reaction Time (computer-based reaction time test)
Reaction time will be assessed using a computer-based reaction time system. Average response time to visual stimuli will be recorded, with shorter times indicating better reaction performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Büşra Seçkinoğulları Korkusuz
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University Ankara Hospital, Atılım University
- Responsible party
- Sponsor-investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Büşra S Korkusuz, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536503
- Sponsor's protocol ID
- E-59394181-604.01-126829
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agargün, M.Y., Kara, H., Anlar, O., et al. (1996) Pittsburgh Uyku Kalitesi Indeksinin Geçerligi Ve Güvenirligi. Türk Psikiyatri Dergisi, 7, 107-115.
Karakaş, S., Erdoğan, E., Soysal, A. Ş., Ulusoy, M., & Alkan, S. (1999). Stroop Test TBAG formu: Standardizasyon çalışması, güvenilirlik ve geçerlilik bulguları. Türk Psikoloji Dergisi, 14(44), 91-115
Jerkovic A, Mikac U, Matijaca M, Kosta V, Curkovic Katic A, Dolic K, Vujovic I, Soda J, Dogas Z, Pavelin S, Rogic Vidakovic M. Psychometric Properties of the Pittsburgh Sleep Quality Index (PSQI) in Patients with Multiple Sclerosis: Factor Structure, Reliability, Correlates, and Discrimination. J Clin Med. 2022 Apr 5;11(7):2037. doi: 10.3390/jcm11072037.
PubMed 35407644
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Quality on Cognitive Flexibility, Physical Activity, Body Awareness, and Reaction Time in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07536503
- Acronym / sponsor ID
- E-59394181-604.01-126829
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Sleep Quality, Cognitive Flexibility, Physical Activity, Reaction Time, Body Awareness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Büşra Seçkinoğulları KorkusuzUniversity, hospital or other
- Collaborators
- Baskent University Ankara Hospital, Atılım University
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Apr 2026 (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 goal of this observational study is to investigate the effects of sleep quality on cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis.
The main question it aims to answer is:
Does sleep quality influence cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis?
Researchers will compare individuals with good and poor sleep quality to determine whether differences in sleep quality result in variations in cognitive and physical performance outcomes.
Participants will complete standardized assessments of sleep quality, cognitive flexibility, physical activity, and body awareness, and will perform a computer-based reaction time test. In addition, participants will wear a wearable activity tracker for 7 days to objectively measure physical activity levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Sleep Quality Group | – | –Participants with Multiple Sclerosis who have a Pittsburgh Sleep Quality Index (PSQI) score of 5 or below, indicating good sleep quality. |
| Poor Sleep Quality Group | – | –Participants with Multiple Sclerosis who have a Pittsburgh Sleep Quality Index (PSQI) score above 5, indicating poor sleep quality. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals aged 18-65 years who have been diagnosed with Multiple Sclerosis and are receiving routine care at the Department of Physical Therapy and Rehabilitation of Başkent University Hospital. Participants who meet the inclusion criteria and voluntarily agree to participate will be enrolled in the study.
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Diagnosis of Multiple Sclerosis
- Montreal Cognitive Assessment (MoCA) score ≥24
- Expanded Disability Status Scale (EDSS) score between 0 and 6.5
- No relapse within the last 3 months
Key exclusion criteria (5 listed)
- Presence of other neurological, psychiatric, or systemic diseases
- Severe visual, auditory, or balance impairments
- History of surgery within the last 6 months
- Use of sleep medication or central nervous system-affecting drugs
- Severe orthopedic deformity or pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Cognitive Flexibility (Stroop Test, TBAG Form)
Time frame: Baseline
Cognitive flexibility will be evaluated using the Stroop Test TBAG Form. Test completion time and number of errors will be recorded; longer completion times and more errors indicate lower cognitive flexibility.
Physical Activity Level (International Physical Activity Questionnaire-Short Form)
Time frame: Baseline
Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form. Total physical activity will be calculated in MET-min/week.
Physical Activity Level (Wearable Device)
Time frame: 7 days
Daily step count will be recorded using a wearable activity tracker. Average step count over 7 days will be calculated.
Body Awareness Questionnaire
Time frame: Baseline
Body awareness will be evaluated using the Body Awareness Questionnaire. Higher scores indicate greater body awareness.
Reaction Time (computer-based reaction time test)
Time frame: Baseline
Reaction time will be assessed using a computer-based reaction time system. Average response time to visual stimuli will be recorded, with shorter times indicating better reaction performance.
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 2 Jun 2026.
- BackgroundAgargün, M.Y., Kara, H., Anlar, O., et al. (1996) Pittsburgh Uyku Kalitesi Indeksinin Geçerligi Ve Güvenirligi. Türk Psikiyatri Dergisi, 7, 107-115.
- BackgroundKarakaş, S., Erdoğan, E., Soysal, A. Ş., Ulusoy, M., & Alkan, S. (1999). Stroop Test TBAG formu: Standardizasyon çalışması, güvenilirlik ve geçerlilik bulguları. Türk Psikoloji Dergisi, 14(44), 91-115
- Background: PubMed 35407644Jerkovic A, Mikac U, Matijaca M, Kosta V, Curkovic Katic A, Dolic K, Vujovic I, Soda J, Dogas Z, Pavelin S, Rogic Vidakovic M. Psychometric Properties of the Pittsburgh Sleep Quality Index (PSQI) in Patients with Multiple Sclerosis: Factor Structure, Reliability, Correlates, and Discrimination. J Clin Med. 2022 Apr 5;11(7):2037. doi: 10.3390/jcm11072037.
- 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.
Büşra S Korkusuz study chair
Ankara University
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, run by Büşra Seçkinoğulları Korkusuz 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 6 inclusion and 5 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 2 Jun 2026. 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 Süleyman Korkusuz, PhD (+905388675480, suleyman.korkusuz@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (Pittsburgh Sleep Quality Index) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536503, which also lists 3 linked publications.
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 2 Jun 2026.