Evaluation of Interoception, Fatigue, and Upper and Lower Extremity Functional Capacity in Multiple Sclerosis Patients With Good and Poor Sleep Quality

NCT07374237 | Completed

• 1 other identifier: 08/1454
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  From November 1, 2025 to June 1, 2026

Study Arms (2)

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.

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 51 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 28, 2026
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 15, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TU (1)