Predictors of fatigue over three months in people with Sjögren's disease
Official title: Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-Month Longitudinal Study
Run by Kahramanmaras Sutcu Imam University · NCT07544394 · Data updated 2026-11-12
This project will try to see if measures taken at baseline—like pain sensitivity, mood, sleep, and activity—predict how fatigue changes over three months in adults with Sjögren's disease who attend a rheumatology clinic.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | April 20, 2028 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07544394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with a diagnosis of Sjögren's disease who are followed in routine care at the Kahramanmaras Sutcu Imam University rheumatology outpatient clinic and can give written informed consent are ideal candidates.
✕Probably not a fit
People with severe somatic or psychiatric disorders, active malignancy, or who are pregnant (and those unable or unwilling to give consent) are excluded and would not be eligible to participate or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective longitudinal observational study following adults with a clinical diagnosis of Sjögren's disease at a rheumatology outpatient clinic. Baseline data will include routine clinical and laboratory information, measurement of pressure pain threshold with a digital algometer, and validated questionnaires on fatigue, disease activity, symptoms, mood, pain catastrophizing, sleep quality, and physical activity. The same assessments will be repeated at a follow-up visit approximately three months later to measure change in fatigue. The primary aim is to determine which baseline clinical and biopsychosocial variables explain variation in fatigue over time, with secondary analyses exploring relationships between fatigue and pain sensitivity, psychological status, sleep, and activity.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify people at higher risk of persistent or worsening fatigue and guide targeted supportive care or referrals.
How similar studies have gone: Prior research in rheumatic diseases has linked mood, sleep, pain sensitivity, and activity to fatigue, but longitudinal studies specifically in Sjögren's disease using pressure pain threshold measures are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Sjögren's syndrome * Age ≥ 18 years * Willingness to participate and provide written informed consent Exclusion Criteria: * Presence of severe somatic or psychiatric disorders * Presence of malignancy * Pregnancy * Refusal to participate or inability to provide written informed consent
Where it's running
-
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Nazli Elif Nacar, phd
- Email: nelifnacar@ksu.edu.tr
- Phone: +90 344 40 85
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.