Fatigue in Primary Sjögren's Syndrome

NCT04802577 | Completed

• 1 other identifier: 2011-KAEK-25 2020/12-10
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Conditions

Sjogren's Syndrome; Fatigue; Pain Syndrome; Depression; Anxiety; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• FACIT-F

  FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE

  day 1

Secondary Outcomes (4)

• BDI

  day 1

• BAI

  day 1

• ISS

  day 1

• PDQ

  day 1

Study Arms (2)

Primary Sjögren's syndrome

The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria

Diagnostic Test: FACT-F questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: Insomnia severity index.; Other: ESSPRI; Other: ESSDAI; Other: Pain Detect Questionnaire

Healthy Controls

Healthy hospital workers without any chronic disease

Diagnostic Test: FACT-F questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: Insomnia severity index.; Other: Pain Detect Questionnaire

Interventions

FACT-F questionnaire DIAGNOSTIC_TEST

The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.

Healthy Controls; Primary Sjögren's syndrome

Beck Depression Inventory DIAGNOSTIC_TEST

The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.

Healthy Controls; Primary Sjögren's syndrome

Beck Anxiety Inventory DIAGNOSTIC_TEST

The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.

Healthy Controls; Primary Sjögren's syndrome

Insomnia severity index. DIAGNOSTIC_TEST

The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.

Healthy Controls; Primary Sjögren's syndrome

ESSPRI OTHER

The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.

Primary Sjögren's syndrome

ESSDAI OTHER

Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator.

Primary Sjögren's syndrome

Pain Detect Questionnaire OTHER

The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.

Healthy Controls; Primary Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.

You may qualify if:

• Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
• Healthy hospital staff

You may not qualify if:

• Pregnant women
• Cancer patients
• Those with other connective tissue diseases other than PSS
• Multiple sclerosis patients
• Chronic obstructive pulmonary disease
• Those with heart failure and adrenal insufficiency
• Those with renal failure: GFR \<60 ml/min
• Anemia: Hemoglobin \<11 g / dl in women, hemoglobin \<12 g / dl in men
• Hypothyroidism: TSH \>5 mu / L
• Those with electrolyte disturbance

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Koray Ayar

Yıldırım, Bursa, 16310, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Erythrocyte sedimentation rate, CRP, routine biochemical tests, and hemogram

MeSH Terms

Conditions

Sjogren's Syndrome; Fatigue; Somatoform Disorders; Depression; Anxiety Disorders; Fibromyalgia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Koray Ayar, M.D.

  Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 17, 2021
• Study Start: January 4, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)