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临床试验/NCT07536503
NCT07536503招募中不适用

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

Büşra Seçkinoğulları Korkusuz1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Sleep Quality (Pittsburgh Sleep Quality Index)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

Sleep Quality (Pittsburgh Sleep Quality Index)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: Baseline

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

Reaction Time (computer-based reaction time test)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Büşra Seçkinoğulları Korkusuz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Büşra Seçkinoğulları Korkusuz

Assist. Prof. Dr

Ankara University

研究点 (1)

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