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Recruiting NCT07536503

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

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Sleep Quality on Cognitive Flexibility, Physical Activity, Body Awareness, and Reaction Time in Multiple Sclerosis

Overview

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.

Primary outcome measures

  • Sleep Quality (Pittsburgh Sleep Quality Index) [Time frame: Baseline]
  • Cognitive Flexibility (Stroop Test, TBAG Form) [Time frame: Baseline]
  • Physical Activity Level (International Physical Activity Questionnaire-Short Form) [Time frame: Baseline]
  • Physical Activity Level (Wearable Device) [Time frame: 7 days]
  • Body Awareness Questionnaire [Time frame: Baseline]
  • Reaction Time (computer-based reaction time test) [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Baskent University Ankara Hospital — Ankara

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. PMID 35407644

Identifiers

NCT: NCT07536503 · E-59394181-604.01-126829

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗