- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07032480
- Original Trial
Association Between Sleep Disorders, Neck Pain, and Depression
June 26, 2025 updated by: ESRA PEHLIVAN, Saglik Bilimleri Universitesi
Association Between Sleep Disorders, Neck Pain, and Depression in Young Adults: A Cross-Sectional Study
This cross-sectional observational study investigates the association between sleep quality, neck pain-related disability, and depression symptoms in young adults aged 18-28.
The research reveals that poor sleep quality is significantly associated with higher depression scores and increased neck disability, emphasizing the need for integrative approaches targeting sleep quality to improve mental and musculoskeletal health outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
265
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
- Name: Esra Pehlivan
- Email: esra.pehlivan@sbu.edu.tr
Study Contact Backup
- Name: Ayşegül Demirel
- Phone Number: +90 539 308 99 38
- Email: demirelaysenur18@gmail.com
Study Locations
-
-
Üsküdar
-
İstanbul, Üsküdar, Turkey, 34668
- Recruiting
- Saglik Bilimleri Universitesi
-
Contact:
- Esra Pehlivan, Associate Professor
- Phone Number: 02164189616
- Email: fztesrakambur@yahoo.com
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy young adults aged 18-28 residing in Istanbul, Turkey.
Participants were recruited via university student pools and personal networks of the researchers.
Description
Inclusion Criteria:
- Aged 18-28
- No history of physical or psychological illness
- Able to provide informed consent
- Voluntarily agreed to participate
Exclusion Criteria:
- History of chronic illness or psychiatric disorder
- Communication difficulties
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 |
Intervention / Treatment |
|---|---|
|
Healthy Sleep Group
Participants who scored 0-5 on the Pittsburgh Sleep Quality Index (PSQI), indicating good sleep quality.
|
Participants completed standardized questionnaires including the Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Neck Disability Index (NDI) to evaluate psychological and functional outcomes associated with sleep quality.
No experimental intervention was administered.
|
|
Poor Sleep Group
Participants who scored between 6-10 on the PSQI, indicating impaired sleep quality.
|
Participants completed standardized questionnaires including the Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Neck Disability Index (NDI) to evaluate psychological and functional outcomes associated with sleep quality.
No experimental intervention was administered.
|
|
Chronic Sleep Disorder Group
Participants who scored above 10 on the PSQI, indicating persistent and clinically relevant sleep disturbances.
|
Participants completed standardized questionnaires including the Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Neck Disability Index (NDI) to evaluate psychological and functional outcomes associated with sleep quality.
No experimental intervention was administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Single assessment at baseline
|
The PSQI is a validated self-report instrument that evaluates sleep quality and disturbances over a 1-month period.
It includes 7 subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component is scored from 0 (no difficulty) to 3 (severe difficulty), resulting in a global score from 0 to 21.
|
Single assessment at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Neck Disability as Measured by the Neck Disability Index (NDI)
Time Frame: Single assessment at baseline
|
The NDI is a 10-item questionnaire that assesses how neck pain affects daily activities such as personal care, lifting, reading, concentration, work, driving, sleeping, and recreation.
Each item is scored from 0 to 5, for a total possible score of 0 to 50.
|
Single assessment at baseline
|
|
Depression Severity as Measured by the Beck Depression Inventory (BDI)
Time Frame: Single assessment at baseline
|
The BDI is a 21-item self-report questionnaire assessing depressive symptoms in individuals.
Each item is rated on a 4-point scale (0 to 3), with a total possible score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
|
Single assessment at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 26, 2025
Primary Completion (Estimated)
June 22, 2026
Study Completion (Estimated)
June 22, 2026
Study Registration Dates
First Submitted
June 14, 2025
First Submitted That Met QC Criteria
June 14, 2025
First Posted (Actual)
June 24, 2025
Study Record Updates
Last Update Posted (Estimated)
July 1, 2025
Last Update Submitted That Met QC Criteria
June 26, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sleep&Neck&Depression
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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 Health Risk Behaviors
-
Istanbul University - Cerrahpasa (IUC)CompletedHealth Risk Behaviors | Reproductive Health | Sexual HealthTurkey
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaNot yet recruitingHealth Risk Behaviors
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaCompleted
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaCompleted
-
University Medicine GreifswaldUniversity Hospital Schleswig-Holstein; Deutsche Krebshilfe e.V., Bonn (Germany) and other collaboratorsCompleted
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaCompleted
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedHealth Risk Behaviors | Risk Reduction BehaviorUnited States
-
Laura RichardsonCompleted
-
University of CalgaryCanadian Institutes of Health Research (CIHR); British Columbia Farmers' Market...CompletedDiet, Healthy | Health Risk BehaviorsCanada
Clinical Trials on Survey-Based Assessment
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingUterine Neoplasms | Ovarian NeoplasmsItaly
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)WithdrawnStage II Uterine Corpus Cancer AJCC v7 | Uterine Carcinosarcoma | Endometrial Carcinoma | Stage II Cervical Cancer AJCC v7 | Stage IIA Cervical Cancer AJCC v7 | Stage IIB Cervical Cancer AJCC v6 and v7 | Stage IIIB Cervical Cancer AJCC v6 and v7 | Stage IVA Cervical Cancer AJCC v6 and v7 | Stage 0 Fallopian... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI); Hope FoundationCompletedCancer Survivor | Stage I Rectosigmoid Cancer | Stage II Rectosigmoid Cancer | Stage III Rectosigmoid CancerUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic Cell Transplantation RecipientUnited States
-
Thomas Jefferson UniversityWithdrawnAcute Myeloid LeukemiaUnited States
-
Suleyman Demirel UniversityRecruitingPain | Knee Osteoarthritis | Kinesiophobia | Amplification | Psychological DisabilityTurkey
-
Penn State UniversityAmerican Heart AssociationCompletedCardiovascular Diseases | Diet Modification | Health Promotion | Preventive Medicine | NutritionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Yale UniversityCompletedSelf Efficacy | Cognitive ReappraisalUnited States
-
St. Jude Children's Research HospitalRecruitingGenetic PredispositionUnited States