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

May 31, 2026 updated by: Büşra Seçkinoğulları Korkusuz

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
7 days
Body Awareness Questionnaire
Time Frame: Baseline
Body awareness will be evaluated using the Body Awareness Questionnaire. Higher scores indicate greater body awareness.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Büşra Seçkinoğulları Korkusuz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atılım University
Baskent University Ankara Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Büşra S Korkusuz, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-59394181-604.01-126829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Multiple Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings