The Impact of Good Versus Poor Sleep Quality on Quality o... | NCT07681037

Studies
The Impact of Good Versus Poor Sleep Quality on Quality of Life, Depression, and Fatigue in Individuals With Multiple Sclerosis

NCT07681037

Sponsor

Trakya University

Status

Completed

Last Update Posted

Jul 2, 2026Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Quality of Life
Depression
Multiple Sclerosis

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2025Actual

Primary Completion Date

Dec 30, 2025Actual

Completion Date

Jan 5, 2026Actual

First Submitted Date

Jun 10, 2026

First Submission Date that Met QC Criteria

Jun 26, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Sleep disorders are common among individuals with multiple sclerosis and negatively impact their physical and psychological well-being. This 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.

Material and Methods: The study was conducted between july 15, 2025 and December 30, 2025 with 121 patients diagnosed with Multiple Sclerosis at the Neurology outpatient clinic of a university hospital in Edirne. Data were collected using "Patient Information 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.

Financial Support: The present study was supported by the Research Fund of Trakya University. Project No: 2025/278

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple Sclerosis		Data were collected using a patient Information Form, the Pittsburgh Sleep Quality Index (PSQI), the

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determining sleep quality	To evaluate the association between sleep quality and quality of life, depression, and fatigue in individuals with multiple sclerosis.	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Having a confirmed diagnosis of multiple sclerosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayfer Gunes	Trakya University Medical Research and Application Centre, Department of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trakya University Faculty of Medicine Dean'S Office Building		Merkez	Edirne	22100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D009103	Multiple Sclerosis
D005221	Fatigue
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided