Effects of Sleep Quality on Functional and Cognitive Outcomes in Multiple Sclerosi

NCT07536503 | Not Yet Recruiting

• 1 other identifier: E-59394181-604.01-126829
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Sleep Quality; Cognitive Flexibility; Physical Activity; Reaction Time; Body Awareness

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  7 days

• Body Awareness Questionnaire

  Body awareness will be evaluated using the Body Awareness Questionnaire. Higher scores indicate greater body awareness.

  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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Büşra Seçkinoğulları Korkusuz: lead
• Baskent University Ankara Hospital: collaborator
• Atılım University: collaborator

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Ankara, 06810, Turkey (Türkiye)

Location

Related Publications (3)

• Agargün, M.Y., Kara, H., Anlar, O., et al. (1996) Pittsburgh Uyku Kalitesi Indeksinin Geçerligi Ve Güvenirligi. Türk Psikiyatri Dergisi, 7, 107-115.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35407644 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavior

Study Officials

• Büşra S Korkusuz

  Ankara University

  STUDY CHAIR

Central Study Contacts

Süleyman Korkusuz, PhD

CONTACT

+905388675480; suleyman.korkusuz@atilim.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)