- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536503
Effects of Sleep Quality on Functional and Cognitive Outcomes in Multiple Sclerosi
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:
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Süleyman Korkusuz, PhD
- Phone Number: +905388675480
- Email: suleyman.korkusuz@atilim.edu.tr
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06810
- Baskent University Ankara Hospital
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Contact:
- Süleyman Korkusuz, PhD
- Phone Number: +905388675480
- Email: suleyman.korkusuz@atilim.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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Poor Sleep Quality Group
Participants with Multiple Sclerosis who have a Pittsburgh Sleep Quality Index (PSQI) score above 5, indicating poor sleep quality.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep Quality (Pittsburgh Sleep Quality Index)
Time Frame: Baseline
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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.
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Baseline
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Cognitive Flexibility (Stroop Test, TBAG Form)
Time Frame: Baseline
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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.
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Baseline
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Physical Activity Level (International Physical Activity Questionnaire-Short Form)
Time Frame: Baseline
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Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form.
Total physical activity will be calculated in MET-min/week.
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Baseline
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Physical Activity Level (Wearable Device)
Time Frame: 7 days
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Daily step count will be recorded using a wearable activity tracker.
Average step count over 7 days will be calculated.
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7 days
|
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Body Awareness Questionnaire
Time Frame: Baseline
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Body awareness will be evaluated using the Body Awareness Questionnaire.
Higher scores indicate greater body awareness.
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Baseline
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Reaction Time (computer-based reaction time test)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Büşra S Korkusuz, Ankara University
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Behavior
- Multiple Sclerosis
- Sleep Initiation and Maintenance Disorders
- Motor Activity
Other Study ID Numbers
- E-59394181-604.01-126829
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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