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Fatigue in Primary Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT04802577
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital

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.

Condition or disease Intervention/treatment
Sjogren's Syndrome Fatigue Pain Syndrome Depression Anxiety Fibromyalgia 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 130 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. FACIT-F [ Time Frame: 1 day ]
    FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE


Secondary Outcome Measures :
  1. BDI [ Time Frame: 1 day ]
    Beck Depression Inventory

  2. BAI [ Time Frame: 1 day ]
    Beck Anxiety Inventory

  3. ISS [ Time Frame: 1 day ]
    Insomnia Severity Scale

  4. PDQ [ Time Frame: 1 day ]
    Pain Detect Questionnaire


Biospecimen Retention:   Samples Without DNA
Erythrocyte sedimentation rate, CRP, routine biochemical tests, and hemogram


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802577


Contacts
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Contact: Koray Ayar, M.D. +902242955000 ayarkoray@hotmail.com

Locations
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Turkey
Koray Ayar Recruiting
Yıldırım, Bursa, Turkey, 16310
Contact: Koray Ayar, M.D.    02242955000    ayarkoray@hotmail.com   
Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital
Investigators
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Principal Investigator: Koray Ayar, M.D. Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
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Responsible Party: Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04802577    
Other Study ID Numbers: 2011-KAEK-25 2020/12-10
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Sjogren's Syndrome
Syndrome
Fatigue
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases