Multiple SclerosisNCT07374237
Evaluation of Interoception, Fatigue, and Upper and Lower Extremity Functional Capacity in Multiple Sclerosis Patients With Good and Poor Sleep Quality
An observational study of Multiple Sclerosis, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic disease of the central nervous system associated with a wide range of motor and non-motor symptoms. Sleep disturbances, fatigue, altered interoceptive perception, and impairments in upper and lower extremity functional capacity are commonly observed in individuals with MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 15 Mar 2026
- How long will I take part?
- 51 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of individuals diagnosed with multiple sclerosis (MS) by a specialist physician. Eligible participants are adults aged 18-65 years, with an Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0, who have not experienced an MS relapse within the past three months. Participants must be able to stand independently for at least 60 seconds without assistive devices and have sufficient cognitive function, defined as a Mini-Mental State Examination score greater than 24. Exclusion criteria include other neurological, visual, or circulatory conditions affecting balance, recent corticosteroid use, pregnancy, significant orthopedic or spinal disorders, and recent medication changes. Written informed consent is obtained from all participants prior to enrollment.
Who may be able to join
- Diagnosed with multiple sclerosis by a specialist physician
- Aged between 18 and 65 years
- No MS relapse within the last 3 months
- Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0
- Ability to stand independently for at least 60 seconds without the use of any assistive device
- No additional neurological disorder or circulatory/visual impairment that may affect balance
- Cognitive function score >24 on the Mini-Mental State Examination (MMSE)
- Provided written informed consent after receiving detailed information about the study
Who cannot join
- Use of corticosteroids within the last 4 weeks
- Pregnancy
- Presence of spinal deformities, disc herniation, or other spinal pathologies
- Presence of orthopedic conditions affecting the hip, knee, or ankle
- History of surgery involving the spine, hip, knee, or ankle
- Change in medication within the last month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06000
About this study
Multiple sclerosis (MS) is a chronic disease of the central nervous system associated with a wide range of motor and non-motor symptoms. Sleep disturbances, fatigue, altered interoceptive perception, and impairments in upper and lower extremity functional capacity are commonly observed in individuals with MS. Decreased sleep quality may exacerbate fatigue and negatively affect daily activities and independence. Therefore, examining the relationships between sleep quality, interoception, fatigue, and extremity functional capacity is essential for effective disease management and the preservation of quality of life in individuals with MS.
The aim of this study is to compare interoception, fatigue, and upper and lower extremity functional capacity between individuals with MS who have good and poor sleep quality and to evaluate the relationships among these variables. By comparing MS patients based on sleep quality, this study seeks to clarify the impact of sleep quality on interoceptive processes, fatigue levels, and functional capacity.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, interoception, fatigue, functional capacity, sleep quality
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Patients with Poor Sleep Quality | Participants with a Pittsburgh Sleep Quality Index (PSQI) total score of 5 or higher, indicating poor sleep quality. | |
| Multiple Sclerosis Patients with Poor Good Quality | Good sleep quality group: Participants with a Pittsburgh Sleep Quality Index (PSQI) total score below 5, indicating good sleep quality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index Total Score
Sleep quality refers to the subjective evaluation of sleep characteristics, including sleep duration, latency, efficiency, disturbances, and daytime dysfunction, and was assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A cut-off score of 5 was applied; scores greater than 5 indicate poor sleep quality, whereas scores less than 5 indicate good sleep quality.
Measured: From November 1, 2025 to June 1, 2026
Interoceptive Accuracy Score
Interoceptive accuracy refers to the ability to accurately perceive internal bodily signals and was assessed using the Heartbeat Counting Task. During the task, participants were instructed to silently count their own heartbeats without manually checking their pulse during predefined time intervals. Simultaneously, actual heartbeats were recorded using a physiological recording device. Interoceptive accuracy was calculated by comparing the number of counted heartbeats with the recorded heartbeats. Scores range from 0 to 1, with higher scores indicating better interoceptive accuracy.
Measured: From November 1, 2025 to June 1, 2026
Fatigue Severity Scale Mean Score
Fatigue severity refers to the perceived intensity and impact of fatigue on daily functioning and was assessed using the Fatigue Severity Scale (FSS). The FSS is a self-report questionnaire consisting of 9 items, each rated on a 7-point Likert scale. The mean score was calculated by averaging the item scores and ranges from 1 to 7, with higher scores indicating greater fatigue severity.
Measured: From November 1, 2025 to June 1, 2026
Multiple Sclerosis Functional Composite (MSFC) Composite Score
Functional capacity refers to the ability to perform motor and cognitive tasks related to daily functioning and was assessed using the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. The MSFC is a composite measure consisting of lower extremity function assessed by the Timed 25-Foot Walk, upper extremity function assessed by the 9-Hole Peg Test, and cognitive processing speed assessed by the Paced Auditory Serial Addition Test. Scores from each component were standardized and combined to generate a composite MSFC score, with higher scores indicating better functional capacity.
Measured: From November 1, 2025 to June 1, 2026
Interoceptive Awareness Scores
Interoceptive awareness refers to the conscious perception and appraisal of internal bodily sensations and was assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) questionnaire. The MAIA-2 is a self-report measure consisting of 32 items assessing multiple dimensions of interoceptive awareness. Total scores range from 0 to 160, with higher scores indicating better interoceptive awareness.
Measured: From November 1, 2025 to June 1, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
- Target duration
- 51 Months
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Çoban, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374237
- Sponsor's protocol ID
- 08/1454
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interoception, Fatigue, and Upper and Lower Extremity Functional Capacity in Multiple Sclerosis Patients With Good and Poor Sleep Quality
- ClinicalTrials.gov ID
- NCT07374237
- Acronym / sponsor ID
- 08/1454
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, interoception, fatigue, functional capacity, sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) is a chronic disease of the central nervous system associated with a wide range of motor and non-motor symptoms. Sleep disturbances, fatigue, altered interoceptive perception, and impairments in upper and lower extremity functional capacity are commonly observed in individuals with MS. Decreased sleep quality may exacerbate fatigue and negatively affect daily activities and independence. Therefore, examining the relationships between sleep quality, interoception, fatigue, and extremity functional capacity is essential for effective disease management and the preservation of quality of life in individuals with MS.
The aim of this study is to compare interoception, fatigue, and upper and lower extremity functional capacity between individuals with MS who have good and poor sleep quality and to evaluate the relationships among these variables. By comparing MS patients based on sleep quality, this study seeks to clarify the impact of sleep quality on interoceptive processes, fatigue levels, and functional capacity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 51 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Patients with Poor Sleep Quality | – | –Participants with a Pittsburgh Sleep Quality Index (PSQI) total score of 5 or higher, indicating poor sleep quality. |
| Multiple Sclerosis Patients with Poor Good Quality | – | –Good sleep quality group: Participants with a Pittsburgh Sleep Quality Index (PSQI) total score below 5, indicating good sleep quality. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals diagnosed with multiple sclerosis (MS) by a specialist physician. Eligible participants are adults aged 18-65 years, with an Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0, who have not experienced an MS relapse within the past three months. Participants must be able to stand independently for at least 60 seconds without assistive devices and have sufficient cognitive function, defined as a Mini-Mental State Examination score greater than 24. Exclusion criteria include other neurological, visual, or circulatory conditions affecting balance, recent corticosteroid use, pregnancy, significant orthopedic or spinal disorders, and recent medication changes. Written informed consent is obtained from all participants prior to enrollment.
Key inclusion criteria (8 listed)
- Diagnosed with multiple sclerosis by a specialist physician
- Aged between 18 and 65 years
- No MS relapse within the last 3 months
- Expanded Disability Status Scale (EDSS) score between 1.0 and 5.0
- Ability to stand independently for at least 60 seconds without the use of any assistive device
Key exclusion criteria (6 listed)
- Use of corticosteroids within the last 4 weeks
- Pregnancy
- Presence of spinal deformities, disc herniation, or other spinal pathologies
- Presence of orthopedic conditions affecting the hip, knee, or ankle
- History of surgery involving the spine, hip, knee, or ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pittsburgh Sleep Quality Index Total Score
Time frame: From November 1, 2025 to June 1, 2026
Sleep quality refers to the subjective evaluation of sleep characteristics, including sleep duration, latency, efficiency, disturbances, and daytime dysfunction, and was assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A cut-off score of 5 was applied; scores greater than 5 indicate poor sleep quality, whereas scores less than 5 indicate good sleep quality.
Interoceptive Accuracy Score
Time frame: From November 1, 2025 to June 1, 2026
Interoceptive accuracy refers to the ability to accurately perceive internal bodily signals and was assessed using the Heartbeat Counting Task. During the task, participants were instructed to silently count their own heartbeats without manually checking their pulse during predefined time intervals. Simultaneously, actual heartbeats were recorded using a physiological recording device. Interoceptive accuracy was calculated by comparing the number of counted heartbeats with the recorded heartbeats. Scores range from 0 to 1, with higher scores indicating better interoceptive accuracy.
Fatigue Severity Scale Mean Score
Time frame: From November 1, 2025 to June 1, 2026
Fatigue severity refers to the perceived intensity and impact of fatigue on daily functioning and was assessed using the Fatigue Severity Scale (FSS). The FSS is a self-report questionnaire consisting of 9 items, each rated on a 7-point Likert scale. The mean score was calculated by averaging the item scores and ranges from 1 to 7, with higher scores indicating greater fatigue severity.
Multiple Sclerosis Functional Composite (MSFC) Composite Score
Time frame: From November 1, 2025 to June 1, 2026
Functional capacity refers to the ability to perform motor and cognitive tasks related to daily functioning and was assessed using the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. The MSFC is a composite measure consisting of lower extremity function assessed by the Timed 25-Foot Walk, upper extremity function assessed by the 9-Hole Peg Test, and cognitive processing speed assessed by the Paced Auditory Serial Addition Test. Scores from each component were standardized and combined to generate a composite MSFC score, with higher scores indicating better functional capacity.
Interoceptive Awareness Scores
Time frame: From November 1, 2025 to June 1, 2026
Interoceptive awareness refers to the conscious perception and appraisal of internal bodily sensations and was assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) questionnaire. The MAIA-2 is a self-report measure consisting of 32 items assessing multiple dimensions of interoceptive awareness. Total scores range from 0 to 160, with higher scores indicating better interoceptive awareness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index Total Score (time frame: From November 1, 2025 to June 1, 2026). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.