NCT07681037

Brief Summary

This cross-sectional study was conducted to examine the effects of good and poor sleep quality on quality of life, depression, and fatigue in individuals with multiple sclerosis. The study was conducted at the Multiple Sclerosis (n=121) Outpatient Clinic of the Health Research and Application Center at the Trakya University between July 15, 2025, and December 30, 2025, with patients who were receiving outpatient treatment, had no communication difficulties, and agreed to participate in the study. These patients were provided with an "Informed Consent Form" "Pittsburgh Sleep Quality Index," "SF-12 Quality of Life Scale," "Beck Depression Scale," and "Fatigue Impact Scale." Participants were informed about the purpose of the study, and if they agreed to participate, they were asked to complete the questionnaire forms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 10, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

FatigueDepressionQuality of lifeMultiple SclerosisSleep Quality

Outcome Measures

Primary Outcomes (1)

  • determining sleep quality

    To evaluate the association between sleep quality and quality of life, depression, and fatigue in individuals with multiple sclerosis.

    6 month

Study Arms (1)

Multiple Sclerosis

Data were collected using a patient Information Form, the Pittsburgh Sleep Quality Index (PSQI), the

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Having a confirmed diagnosis of multiple sclerosis

You may qualify if:

  • Being over 18 years of age
  • Having a confirmed diagnosis of multiple sclerosis
  • Being a registered patient at a multiple sclerosis clinic
  • Not experiencing communication difficulties
  • Volunteering to participate in the study

You may not qualify if:

  • Being under 18 years of age
  • Not having a confirmed diagnosis of multiple sclerosis
  • Not currently attending a multiple sclerosis clinic
  • Experiencing communication difficulties
  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University Faculty of Medicine Dean'S Office Building

Merkez, Edirne, 22100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionMultiple SclerosisFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Ayfer Gunes

    Trakya University Medical Research and Application Centre, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. (PhD), RN, Principal Investigator

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 2, 2026

Study Start

July 15, 2025

Primary Completion

December 30, 2025

Study Completion

January 5, 2026

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations