Fatigue in Primary Sjögren's Syndrome

The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Depression; Fatigue; Fibromyalgia; Anxiety; Sjogren's Syndrome; Pain Syndrome
• Intervention / Treatment: 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

Detailed Description

While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Turkey
  • Bursa
    • Yıldırım, Bursa, Turkey, 16310
      • Koray Ayar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Sjögren's syndrome; The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria	Diagnostic test: FACT-F questionnaire; The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.; Diagnostic test: Beck Depression Inventory; The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.; Diagnostic test: Beck Anxiety Inventory; The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.; Diagnostic test: Insomnia severity index.; The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.; Other: ESSPRI; The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.; Other: ESSDAI; 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.; Other: Pain Detect Questionnaire; 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; Healthy hospital workers without any chronic disease	Diagnostic test: FACT-F questionnaire; The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.; Diagnostic test: Beck Depression Inventory; The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.; Diagnostic test: Beck Anxiety Inventory; The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.; Diagnostic test: Insomnia severity index.; The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.; Other: Pain Detect Questionnaire; The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACIT-F	FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BDI	Beck Depression Inventory	day 1
BAI	Beck Anxiety Inventory	day 1
ISS	Insomnia Severity Scale	day 1
PDQ	Pain Detect Questionnaire	day 1

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Koray Ayar, M.D., Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Fatigue; Fibromyalgia; Sjogren's Syndrome
• Other Study ID Numbers: 2011-KAEK-25 2020/12-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No